Trial Outcomes & Findings for Helping Improve Pediatric Patient Outcomes (NCT NCT03471221)
NCT ID: NCT03471221
Last Updated: 2026-06-15
Results Overview
The Pediatric Quality of Life Present Functioning Visual Analog Scale total score is a measure of present or in-the-moment distress. It is computed as the average of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower total distress.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Immediately after first visit (Intention to Treat)
Results posted on
2026-06-15
Participant Flow
Parent Participants are not counted as Enrolled in the Participant Flow numbers because only Child Participants are randomized and eligible to receive the Intervention. Parent Participants do not participate in any Intervention activities and only complete 1 data collection activity.
Participant milestones
| Measure |
Therapy Dog Visits
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
Control Group
Participants randomized to the Control Group will receive usual medical care.
|
Parents of Enrolled Children Randomized to Therapy Dog Visits
This group includes parents of children randomized to the Therapy Dog Visits Group who Enrolled to provide parent data for the STAI Measure
|
Parents of Enrolled Children Randomized to the Control Group
This group includes parents of children randomized to the Control Group who Enrolled to provide parent data for the STAI Measure
|
|---|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
1
|
|
Overall Study
STARTED
|
12
|
14
|
9
|
10
|
|
Overall Study
COMPLETED
|
12
|
12
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data on Age was only collected for Child Participants.
Baseline characteristics by cohort
| Measure |
Therapy Dog Visits
n=12 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
Control Group
n=14 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Parents of Enrolled Children Randomized to Therapy Dog Visits
n=9 Participants
This group includes parents of children randomized to the Therapy Dog Visits Group who Enrolled to provide parent data for the STAI Measure
|
Parents of Enrolled Children Randomized to the Control Group
n=10 Participants
This group includes parents of children randomized to the Control Group who Enrolled to provide parent data for the STAI Measure
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
11.7 years
STANDARD_DEVIATION 4.0 • n=12 Participants • Data on Age was only collected for Child Participants.
|
12.7 years
STANDARD_DEVIATION 2.7 • n=14 Participants • Data on Age was only collected for Child Participants.
|
—
|
—
|
12.3 years
STANDARD_DEVIATION 3.3 • n=26 Participants • Data on Age was only collected for Child Participants.
|
|
Sex: Female, Male
Female
|
5 Participants
n=12 Participants
|
6 Participants
n=14 Participants
|
8 Participants
n=9 Participants
|
8 Participants
n=10 Participants
|
27 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=12 Participants
|
8 Participants
n=14 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=10 Participants
|
18 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants • Data on Race was only collected for Child Participants
|
2 Participants
n=14 Participants • Data on Race was only collected for Child Participants
|
—
|
—
|
2 Participants
n=26 Participants • Data on Race was only collected for Child Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=12 Participants • Data on Race was only collected for Child Participants
|
0 Participants
n=14 Participants • Data on Race was only collected for Child Participants
|
—
|
—
|
0 Participants
n=26 Participants • Data on Race was only collected for Child Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=12 Participants • Data on Race was only collected for Child Participants
|
0 Participants
n=14 Participants • Data on Race was only collected for Child Participants
|
—
|
—
|
1 Participants
n=26 Participants • Data on Race was only collected for Child Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=12 Participants • Data on Race was only collected for Child Participants
|
0 Participants
n=14 Participants • Data on Race was only collected for Child Participants
|
—
|
—
|
0 Participants
n=26 Participants • Data on Race was only collected for Child Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=12 Participants • Data on Race was only collected for Child Participants
|
8 Participants
n=14 Participants • Data on Race was only collected for Child Participants
|
—
|
—
|
18 Participants
n=26 Participants • Data on Race was only collected for Child Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=12 Participants • Data on Race was only collected for Child Participants
|
0 Participants
n=14 Participants • Data on Race was only collected for Child Participants
|
—
|
—
|
0 Participants
n=26 Participants • Data on Race was only collected for Child Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=12 Participants • Data on Race was only collected for Child Participants
|
4 Participants
n=14 Participants • Data on Race was only collected for Child Participants
|
—
|
—
|
5 Participants
n=26 Participants • Data on Race was only collected for Child Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=12 Participants • Data on Ethnicity was only collected for child participants.
|
2 Participants
n=14 Participants • Data on Ethnicity was only collected for child participants.
|
—
|
—
|
4 Participants
n=26 Participants • Data on Ethnicity was only collected for child participants.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=12 Participants • Data on Ethnicity was only collected for child participants.
|
10 Participants
n=14 Participants • Data on Ethnicity was only collected for child participants.
|
—
|
—
|
20 Participants
n=26 Participants • Data on Ethnicity was only collected for child participants.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants • Data on Ethnicity was only collected for child participants.
|
2 Participants
n=14 Participants • Data on Ethnicity was only collected for child participants.
|
—
|
—
|
2 Participants
n=26 Participants • Data on Ethnicity was only collected for child participants.
|
|
Region of Enrollment
United States
|
12 Participants
n=12 Participants
|
14 Participants
n=14 Participants
|
9 Participants
n=9 Participants
|
10 Participants
n=10 Participants
|
45 Participants
n=45 Participants
|
|
PedsQLTM Present Functioning Visual Analog Scales total score
|
25 units on a scale
STANDARD_DEVIATION 25 • n=12 Participants • Data on the PedsQLTM Present Functioning Visual Analog Scales total score was only collected for Child Participants.
|
22 units on a scale
STANDARD_DEVIATION 17 • n=14 Participants • Data on the PedsQLTM Present Functioning Visual Analog Scales total score was only collected for Child Participants.
|
—
|
—
|
23 units on a scale
STANDARD_DEVIATION 21 • n=26 Participants • Data on the PedsQLTM Present Functioning Visual Analog Scales total score was only collected for Child Participants.
|
|
Total microbial load on left hand
|
2.93 CFU/mL on log 10 scale
STANDARD_DEVIATION 1.39 • n=12 Participants • Data on Total microbial load on left hand was only collected for Child Participants
|
3.61 CFU/mL on log 10 scale
STANDARD_DEVIATION 1.18 • n=14 Participants • Data on Total microbial load on left hand was only collected for Child Participants
|
—
|
—
|
3.29 CFU/mL on log 10 scale
STANDARD_DEVIATION 1.30 • n=26 Participants • Data on Total microbial load on left hand was only collected for Child Participants
|
|
Total microbial load on right hand
|
3.46 CFU/mL on log10 scale
STANDARD_DEVIATION 1.21 • n=12 Participants • Data on Total microbial load on right hand was only collected on Child Participants.
|
3.88 CFU/mL on log10 scale
STANDARD_DEVIATION 0.92 • n=14 Participants • Data on Total microbial load on right hand was only collected on Child Participants.
|
—
|
—
|
3.69 CFU/mL on log10 scale
STANDARD_DEVIATION 1.07 • n=26 Participants • Data on Total microbial load on right hand was only collected on Child Participants.
|
PRIMARY outcome
Timeframe: Immediately after first visit (Intention to Treat)Population: Two out of 14 patients randomized to the control arm did not have a visit 1; one out of 12 patients randomized to the intervention group did not complete the survey.
The Pediatric Quality of Life Present Functioning Visual Analog Scale total score is a measure of present or in-the-moment distress. It is computed as the average of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower total distress.
Outcome measures
| Measure |
Control Group
n=12 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=11 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Distress Score
|
13.6 score on a scale
Standard Deviation 12.8
|
—
|
—
|
11.0 score on a scale
Standard Deviation 12.5
|
PRIMARY outcome
Timeframe: Immediately after first visit (Intention to Treat and Per Protocol)Population: 12 intervention patients (24 hands) and 12 control patients (24 hands) \[excluding 2 control patients who did not have a visit 1\]
Microbial load on child hands
Outcome measures
| Measure |
Control Group
n=24 Hands
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=24 Hands
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Microbial Load (Colony Forming Units; Cfu) on Child Hands
|
3.39 Colony Forming Units/mL on log10 scale
Standard Deviation 1.01
|
—
|
—
|
3.03 Colony Forming Units/mL on log10 scale
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: Immediately after first visit (Per Protocol)Population: Per protocol analyses are equivalent to intention-to-treat analyses since all intervention patients received a dog visit and none of the control group patients who had a first visit were medically ineligible for a dog visit.
The PedsQL VAS total score is a measure of present or in-the-moment distress. It is computed as the average of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower total distress.
Outcome measures
| Measure |
Control Group
n=12 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=11 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Distress Score
|
13.6 units on a scale
Standard Deviation 12.8
|
—
|
—
|
11.0 units on a scale
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: Immediately after first visit (Intention to Treat)Population: Two out of 14 patients randomized to the control arm did not have a visit 1; one out of 12 patients randomized to the intervention group did not complete the survey.
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS). Each of 6 individual scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt) ranges from 0-100, with lower scores indicating a better outcome.
Outcome measures
| Measure |
Control Group
n=12 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=11 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Individual Scales (Afraid/Scared, Sad/Blue, Angry, Worry, Tired, Pain/Hurt)
Worry (worry)
|
11.8 score on a scale
Standard Deviation 17.0
|
—
|
—
|
13.9 score on a scale
Standard Deviation 20.7
|
|
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Individual Scales (Afraid/Scared, Sad/Blue, Angry, Worry, Tired, Pain/Hurt)
Anxiety (afraid/scared)
|
4.2 score on a scale
Standard Deviation 6.2
|
—
|
—
|
5.1 score on a scale
Standard Deviation 10.3
|
|
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Individual Scales (Afraid/Scared, Sad/Blue, Angry, Worry, Tired, Pain/Hurt)
Sadness (sad/blue)
|
8.8 score on a scale
Standard Deviation 12.0
|
—
|
—
|
5.3 score on a scale
Standard Deviation 8.4
|
|
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Individual Scales (Afraid/Scared, Sad/Blue, Angry, Worry, Tired, Pain/Hurt)
Anger (angry)
|
7.2 score on a scale
Standard Deviation 13.6
|
—
|
—
|
8.6 score on a scale
Standard Deviation 20.9
|
|
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Individual Scales (Afraid/Scared, Sad/Blue, Angry, Worry, Tired, Pain/Hurt)
Fatigue (tired)
|
33.6 score on a scale
Standard Deviation 26.9
|
—
|
—
|
26.7 score on a scale
Standard Deviation 35.0
|
|
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Individual Scales (Afraid/Scared, Sad/Blue, Angry, Worry, Tired, Pain/Hurt)
Pain (pain/hurt)
|
15.9 score on a scale
Standard Deviation 24.7
|
—
|
—
|
6.5 score on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Immediately after first visit (Intention to Treat)Population: Two out of 14 patients randomized to the control arm did not have a visit 1; one out of 12 patients randomized to the intervention group did not complete the survey
The PedsQL VAS emotional distress summary score is a measure of present or in-the-moment emotional distress. It is computed as the average of 4 scales (afraid/scared, sad/blue, angry, worry). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower emotional distress.
Outcome measures
| Measure |
Control Group
n=12 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=11 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Emotional Distress Summary Score.
|
8.0 units on a scale
Standard Deviation 11.4
|
—
|
—
|
8.2 units on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Immediately after first visit (Intention to Treat and Per Protocol)Population: excluding 2 control patients who did not have a visit 1
The presence of each of the following nine organisms: Staphylococcus aureus (further evaluated for methicillin-resistance); Vancomycin-resistant enterococci; Malassezia; Aspergillus; Pasteurella; Enterobacteriaceae (further assessed for multidrug resistance); Acinetobacter (further assessed for multidrug resistance); Pseudomonas aeruginosa (further assessed for multidrug resistance); Clostridium difficile
Outcome measures
| Measure |
Control Group
n=12 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=12 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Number of Participants With the Presence of Clinically Important Organisms
Staphylococcus aureus
|
3 Participants
|
—
|
—
|
1 Participants
|
|
Number of Participants With the Presence of Clinically Important Organisms
Vancomycin-resistant enterococci
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With the Presence of Clinically Important Organisms
Malassezia
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With the Presence of Clinically Important Organisms
Aspergillus
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With the Presence of Clinically Important Organisms
Pasteurella
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With the Presence of Clinically Important Organisms
Enterobacteriaceae
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With the Presence of Clinically Important Organisms
Acinetobacter
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Number of Participants With the Presence of Clinically Important Organisms
Pseudomonas aeruginosa
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With the Presence of Clinically Important Organisms
Clostridium difficile
|
0 Participants
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge, (Intention to Treat)Population: Patients who completed the follow-up assessment at each time point.
Treatment anxiety is one dimension measured within the PedsQL Cancer Module. It consists of 3 questions on a Likert scale. Items are reversed scored and linearly transformed on a 0-100 scale and then averaged. Higher scores indicate lower treatment anxiety.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=5 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL) Cancer Module: Treatment Anxiety Dimension
Hospital discharge
|
85.4 score on a scale
Standard Deviation 23.9
|
—
|
—
|
85.0 score on a scale
Standard Deviation 17.1
|
|
Pediatric Quality of Life Inventory (PedsQL) Cancer Module: Treatment Anxiety Dimension
3 days post-hospital discharge
|
94.4 score on a scale
Standard Deviation 13.6
|
—
|
—
|
83.3 score on a scale
Standard Deviation 28.9
|
|
Pediatric Quality of Life Inventory (PedsQL) Cancer Module: Treatment Anxiety Dimension
9-weeks post-hospital discharge
|
95.8 score on a scale
Standard Deviation 8.3
|
—
|
—
|
81.7 score on a scale
Standard Deviation 24.6
|
SECONDARY outcome
Timeframe: Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge), (Intention to Treat)Population: Patients who completed the follow-up assessment at each time point
Each feeling (afraid/scared, sad/blue, angry, worried) is measured as either, not present, a little bit present, present, or strongly present.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=5 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - 3 days post-hospital discharge · _____ (Experiences the emotion)
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - Hospital discharge · Not at all _____
|
5 Participants
|
—
|
—
|
3 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - Hospital discharge · A little _____
|
3 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - Hospital discharge · _____ (Experiences the emotion)
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - Hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - 3 days post-hospital discharge · Not at all _____
|
4 Participants
|
—
|
—
|
2 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - 3 days post-hospital discharge · A little _____
|
2 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - 3 days post-hospital discharge · Not at all _____
|
4 Participants
|
—
|
—
|
2 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - 3 days post-hospital discharge · A little _____
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - 9-weeks post-hospital discharge · Not at all _____
|
4 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - 9-weeks post-hospital discharge · A little _____
|
0 Participants
|
—
|
—
|
2 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - 3 days post-hospital discharge · Not at all _____
|
5 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - 3 days post-hospital discharge · _____ (Experiences the emotion)
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - 3 days post-hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - Hospital discharge · Not at all _____
|
4 Participants
|
—
|
—
|
2 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - Hospital discharge · Not at all _____
|
4 Participants
|
—
|
—
|
3 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - Hospital discharge · A little _____
|
3 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - Hospital discharge · _____ (Experiences the emotion)
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - Hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - 3 days post-hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - 9-weeks post-hospital discharge · Not at all _____
|
4 Participants
|
—
|
—
|
2 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - 9-weeks post-hospital discharge · A little _____
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - 9-weeks post-hospital discharge · _____ (Experiences the emotion)
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anxiety - 9-weeks post-hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - Hospital discharge · Not at all _____
|
2 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - Hospital discharge · A little _____
|
4 Participants
|
—
|
—
|
3 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - Hospital discharge · _____ (Experiences the emotion)
|
2 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - Hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - 3 days post-hospital discharge · _____ (Experiences the emotion)
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - 3 days post-hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - 9-weeks post-hospital discharge · Not at all _____
|
2 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - 9-weeks post-hospital discharge · A little _____
|
2 Participants
|
—
|
—
|
3 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - 9-weeks post-hospital discharge · _____ (Experiences the emotion)
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Sadness - 9-weeks post-hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - 3 days post-hospital discharge · A little _____
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - 9-weeks post-hospital discharge · Not at all _____
|
3 Participants
|
—
|
—
|
2 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - 9-weeks post-hospital discharge · A little _____
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - 9-weeks post-hospital discharge · _____ (Experiences the emotion)
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Anger - 9-weeks post-hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - Hospital discharge · A little _____
|
3 Participants
|
—
|
—
|
2 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - Hospital discharge · _____ (Experiences the emotion)
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - Hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - 3 days post-hospital discharge · Not at all _____
|
5 Participants
|
—
|
—
|
2 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - 3 days post-hospital discharge · A little _____
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - 3 days post-hospital discharge · _____ (Experiences the emotion)
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - 3 days post-hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - 9-weeks post-hospital discharge · _____ (Experiences the emotion)
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Worry - 9-weeks post-hospital discharge · Very _____
|
0 Participants
|
—
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)Population: Patients who completed the follow-up assessment at each time point
The parent report of the child's positive affect consists of 5 positive feelings/emotions each scored on a 5-point Likert scale. Low scores represent worse outcomes. The total score (range: 5-25) is obtained by summing the items.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=6 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
The Positive and Negative Affect Schedule (PANAS): Parent Measure of Child's Positive Affect
Hospital discharge
|
15.6 score on a scale
Standard Deviation 3.1
|
—
|
—
|
13.8 score on a scale
Standard Deviation 6.9
|
|
The Positive and Negative Affect Schedule (PANAS): Parent Measure of Child's Positive Affect
3 days post-hospital discharge
|
14.2 score on a scale
Standard Deviation 4.1
|
—
|
—
|
16.0 score on a scale
Standard Deviation 5.3
|
|
The Positive and Negative Affect Schedule (PANAS): Parent Measure of Child's Positive Affect
9-weeks post-hospital discharge
|
13.8 score on a scale
Standard Deviation 5.7
|
—
|
—
|
17.0 score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)Population: Patients who completed the follow-up assessment at each time point
The parent report of the child's negative affect consists of 5 negative feelings/emotions each scored on a 5-point Likert scale. Low scores represent better outcomes. The total score (range: 5-25) is obtained by summing the items.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=6 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
The Positive and Negative Affect Schedule (PANAS): Parent Measure of Child's Negative Affect
Hospital discharge
|
10.9 score on a scale
Standard Deviation 5.5
|
—
|
—
|
10.7 score on a scale
Standard Deviation 6.4
|
|
The Positive and Negative Affect Schedule (PANAS): Parent Measure of Child's Negative Affect
3 days post-hospital discharge
|
9.8 score on a scale
Standard Deviation 5.3
|
—
|
—
|
12.7 score on a scale
Standard Deviation 7.0
|
|
The Positive and Negative Affect Schedule (PANAS): Parent Measure of Child's Negative Affect
9-weeks post-hospital discharge
|
11.2 score on a scale
Standard Deviation 4.8
|
—
|
—
|
9.5 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Immediately after first visit, (Intention to Treat)Population: One out of 10 parents of patients randomized to the control group who consented to participate in the study did not complete the survey
The short form of the Spielberger State-Trait Anxiety scale will be used to measure parent anxiety. It consists of six items, each on a 4-point Likert scale. The total score is obtained by reverse scoring the three positive items, summing the six scores together, and then multiplying by 20/6. Total scores range from 20 to 80 with higher numbers representing worse outcomes. Nineteen parents participated (9 from the intervention group and 10 from the control group).
Outcome measures
| Measure |
Control Group
n=9 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=9 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Six-item Short-form of the State Scale of the Spielberger State-Trait Anxiety Inventory (STAI)
|
46.3 score on a scale
Standard Deviation 11.6
|
—
|
—
|
38.9 score on a scale
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)Population: Parents who completed the follow-up assessment at each time point
Parents rate the hospital on a 11-point Likert scale. Scores range from 0 to 10. Lower scores represent worse hospital ratings.
Outcome measures
| Measure |
Control Group
n=5 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=5 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Parent Rating of Hospital
Hospital discharge
|
8.6 score on a scale
Standard Deviation 0.5
|
—
|
—
|
9.4 score on a scale
Standard Deviation 0.5
|
|
Parent Rating of Hospital
3 days post-hospital discharge
|
8.6 score on a scale
Standard Deviation 0.9
|
—
|
—
|
10.0 score on a scale
Standard Deviation 0.0
|
|
Parent Rating of Hospital
9-weeks post-hospital discharge
|
8.0 score on a scale
Standard Deviation 1.4
|
—
|
—
|
10.0 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Immediately after first visitPopulation: Of the 24 hands of the 12 intervention patients who had a visit, 15 hands (from 10 patients) were included in this analysis; all 24 hands from 12 control group patients who had a visit were included.
Microbial load on hands that touched the dog versus hands of medically eligible controls
Outcome measures
| Measure |
Control Group
n=24 hands
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=15 hands
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Microbial Load (Colony Forming Units; Cfu) on Hands That Touched the Dog Versus Hands of Medically Eligible Controls
|
3.39 log10 CFU/mL
Standard Deviation 1.01
|
—
|
—
|
2.74 log10 CFU/mL
Standard Deviation 1.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately before and immediately after first visitMicrobial load change from pre-visit to post-visit in the intervention group; only among participants who got a dog visit and only the hand(s) that touched the dog.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment through 1-month post-completion of participation (participation = up to 4-weeks post-enrollment).Counts of persons and Infections/Positive Cultures, including descriptions
Outcome measures
| Measure |
Control Group
n=14 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=12 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Infections
No infections
|
11 Participants
|
—
|
—
|
8 Participants
|
|
Infections
1 infection
|
2 Participants
|
—
|
—
|
3 Participants
|
|
Infections
2 infections
|
1 Participants
|
—
|
—
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately before and immediately after first visitScore change from pre-visit to post-visit. The PedsQL VAS total score is a measure of present or in-the-moment distress. It is computed as the average of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower total distress. Score changes can range from -100 to 100. Negative changes in scores indicate better outcomes. Intervention Group only and only participants who received a dog visit.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately before and immediately after first visitScore change from pre-visit to post-visit. The PedsQL VAS emotional distress summary score is a measure of present or in-the-moment emotional distress. It is computed as the average of 4 scales (afraid/scared, sad/blue, angry, worry). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower emotional distress. Score changes can range from -100 to 100. Negative changes in scores indicate better outcomes. Intervention Group only and only participants who received a dog visit.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately before and immediately after first visitIndividual item change from pre-visit to post-visit. Each of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt) ranges from 0-100, with lower scores indicating a better outcome. Score changes can range from -100 to 100. Negative changes in scores indicate better outcomes. Intervention Group only and only participants who received a dog visit.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately after first visit, (Intention to Treat), Stratified by AgePopulation: Analysis includes patients with a visit 1 who completed the survey
The PedsQL VAS total score is a measure of present or in-the-moment distress. It is computed as the average of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower total distress.
Outcome measures
| Measure |
Control Group
n=4 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
n=8 Participants
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
n=4 Participants
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=7 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Score Stratified by Age
|
13.4 units on a scale
Standard Deviation 18.3
|
13.0 units on a scale
Standard Deviation 10.4
|
14.7 units on a scale
Standard Deviation 18.5
|
9.7 units on a scale
Standard Deviation 9.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Hospital discharge (hospital discharge date varies by patient, 3 days post-hospital discharge, and 9-weeks post-hospital discharge), (Intention to Treat)Population: Patients who completed the follow-up assessment at each time point.
The PedsQL Cancer Module measures quality of life in children and teens with cancer based on 8 dimensions (pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication). Items are reversed scored and linearly transformed on a 0-100 scale and then summed and divided by the number of items answered. Higher scores indicate better outcomes.
Outcome measures
| Measure |
Control Group
n=8 Participants
Participants randomized to the Control Group will receive usual medical care.
|
Control Group (Age 5-12)
Patients who were age 5-12 years in the control group
|
Control Group (Age 13-17)
Patients who were age 13-17 years in the control group
|
Therapy Dog Visits
n=5 Participants
Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity.
Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler.
All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Therapy Dog Visit: Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.
|
|---|---|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL) Cancer Module
Hospital discharge
|
75.9 score on a scale
Standard Deviation 12.0
|
—
|
—
|
79.1 score on a scale
Standard Deviation 9.7
|
|
Pediatric Quality of Life Inventory (PedsQL) Cancer Module
3 days post-hospital discharge
|
83.2 score on a scale
Standard Deviation 11.0
|
—
|
—
|
75.9 score on a scale
Standard Deviation 24.7
|
|
Pediatric Quality of Life Inventory (PedsQL) Cancer Module
9-weeks post-hospital discharge
|
81.9 score on a scale
Standard Deviation 16.6
|
—
|
—
|
76.9 score on a scale
Standard Deviation 13.7
|
Adverse Events
Therapy Dog Visits
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place