Trial Outcomes & Findings for Oxytocin Pathways and the Health Effects of Human-Animal Interaction (NCT NCT03852264)
NCT ID: NCT03852264
Last Updated: 2024-11-12
Results Overview
Change from baseline measured as the area under the curve with respect to the initial value (AUCi).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
baseline, 15 minutes
Results posted on
2024-11-12
Participant Flow
Participants were recruited from the local community through email listservs, print advertisements, social media, and flyers distributed to schools, libraries, museums, and veterinary clinics. Recruitment occurred between February 1, 2019 and February 1, 2022.
None / not applicable
Participant milestones
| Measure |
Pet Dog Interaction First, Then Nonsocial Control, Then Unfamiliar Dog Interaction
Participant's first study visit involved 25 minutes of interaction with the participant's pet dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with an unfamiliar dog.
|
Unfamiliar Dog Interaction First, Then Nonsocial Control, Then Pet Dog Interaction
Participant's first study visit involved 25 minutes of interaction with an unfamiliar dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with the participant's pet dog.
|
|---|---|---|
|
First Research Visit
STARTED
|
30
|
25
|
|
First Research Visit
COMPLETED
|
30
|
25
|
|
First Research Visit
NOT COMPLETED
|
0
|
0
|
|
Second Research Visit
STARTED
|
30
|
25
|
|
Second Research Visit
COMPLETED
|
30
|
25
|
|
Second Research Visit
NOT COMPLETED
|
0
|
0
|
|
Third Research Visit
STARTED
|
30
|
25
|
|
Third Research Visit
COMPLETED
|
29
|
25
|
|
Third Research Visit
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Pet Dog Interaction First, Then Nonsocial Control, Then Unfamiliar Dog Interaction
Participant's first study visit involved 25 minutes of interaction with the participant's pet dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with an unfamiliar dog.
|
Unfamiliar Dog Interaction First, Then Nonsocial Control, Then Pet Dog Interaction
Participant's first study visit involved 25 minutes of interaction with an unfamiliar dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with the participant's pet dog.
|
|---|---|---|
|
Third Research Visit
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Oxytocin Pathways and the Health Effects of Human-Animal Interaction
Baseline characteristics by cohort
| Measure |
Pet Dog Interaction First, Then Nonsocial Control, Then Unfamiliar Dog Interaction
n=30 Participants
Participant's first study visit involved 25 minutes of interaction with the participant's pet dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with an unfamiliar dog.
|
Unfamiliar Dog Interaction First, Then Nonsocial Control, Then Pet Dog Interaction
n=25 Participants
Participant's first study visit involved 25 minutes of interaction with an unfamiliar dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with the participant's pet dog.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
25 participants
n=107 Participants
|
55 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, 15 minutesPopulation: All study participants for whom saliva samples were available for analysis
Change from baseline measured as the area under the curve with respect to the initial value (AUCi).
Outcome measures
| Measure |
Pet Dog Interaction
n=55 Participants
Participants interacted with their pet dog
|
Unfamiliar Dog Interaction
n=53 Participants
Participants interacted with a dog who was unfamiliar to them
|
Toys Interaction
n=55 Participants
Participants interacted with an assortment of toys
|
|---|---|---|---|
|
Salivary Oxytocin, Area Under the Curve
|
-3.03 pg/mL x minutes
Standard Error 1.59
|
-3.83 pg/mL x minutes
Standard Error 1.67
|
-5.57 pg/mL x minutes
Standard Error 1.73
|
PRIMARY outcome
Timeframe: baseline, 50 minutesPopulation: All children with urine samples available for analysis
Change from baseline measured as the area under the curve with respect to the initial value (AUCi).
Outcome measures
| Measure |
Pet Dog Interaction
n=52 Participants
Participants interacted with their pet dog
|
Unfamiliar Dog Interaction
n=46 Participants
Participants interacted with a dog who was unfamiliar to them
|
Toys Interaction
n=50 Participants
Participants interacted with an assortment of toys
|
|---|---|---|---|
|
Urinary Oxytocin, Area Under the Curve
|
0.261 pg/ml x minutes
Standard Error 0.372
|
-0.219 pg/ml x minutes
Standard Error 0.366
|
-0.180 pg/ml x minutes
Standard Error 0.407
|
SECONDARY outcome
Timeframe: baseline, 50 minutesPopulation: All participants with saliva samples available for analysis
Change from baseline measured as the area under the curve with respect to the initial value (AUCi).
Outcome measures
| Measure |
Pet Dog Interaction
n=55 Participants
Participants interacted with their pet dog
|
Unfamiliar Dog Interaction
n=54 Participants
Participants interacted with a dog who was unfamiliar to them
|
Toys Interaction
n=54 Participants
Participants interacted with an assortment of toys
|
|---|---|---|---|
|
Salivary Cortisol, Area Under the Curve
|
-99.7 pg/mL x minutes
Standard Error 20.2
|
-221.1 pg/mL x minutes
Standard Error 70.1
|
-103.0 pg/mL x minutes
Standard Error 29.2
|
SECONDARY outcome
Timeframe: baseline, 50 minutesPopulation: unable to complete assay for this outcome
Change from baseline measured as the area under the curve with respect to the initial value (AUCi).
Outcome measures
Outcome data not reported
Adverse Events
Pet Dog Interaction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unfamiliar Dog Interaction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Toys Interaction
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