Trial Outcomes & Findings for Pilot Study of Nursing Touch and Biobehavioral Stress (NCT NCT05030233)
NCT ID: NCT05030233
Last Updated: 2025-02-18
Results Overview
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
during intervention or control period, approximately 20 minutes
Results posted on
2025-02-18
Participant Flow
Participant milestones
| Measure |
Experimental: Nurse-Administered Touch Intervention, Then Standard Care
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care provided as standard care.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine.
|
Experimental: Standard Care, Then Nurse-Administered Touch Intervention
Preterm infants will receive one episode of essential nursing care delivered as standard care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care that includes the nurse-administered touch intervention.
Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
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|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Experimental: Nurse-Administered Touch Intervention, Then Standard Care
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care provided as standard care.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine.
|
Experimental: Standard Care, Then Nurse-Administered Touch Intervention
Preterm infants will receive one episode of essential nursing care delivered as standard care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care that includes the nurse-administered touch intervention.
Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
|
|---|---|---|
|
Overall Study
withdrawn for transfer
|
1
|
0
|
Baseline Characteristics
Pilot Study of Nursing Touch and Biobehavioral Stress
Baseline characteristics by cohort
| Measure |
Experimental: Nurse-Administered Touch Intervention, Then Standard Care
n=10 Participants
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care provided as standard care.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine.
|
Experimental: Standard Care, Then Nurse-Administered Touch Intervention
n=9 Participants
Preterm infants will receive one episode of essential nursing care delivered as standard care followed by a 24-hour washout period. Then, infants will receive an episode of essential nursing care that includes the nurse-administered touch intervention.
Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 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
|
|
Age, Continuous
|
28.9 weeks gestation at birth
n=99 Participants
|
28.7 weeks gestation at birth
n=107 Participants
|
28.8 weeks gestation at birth
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 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
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Birthweight
|
1339 grams
n=99 Participants
|
1158.4 grams
n=107 Participants
|
1253.5 grams
n=206 Participants
|
PRIMARY outcome
Timeframe: during intervention or control period, approximately 20 minutesPopulation: 19 enrolled infants in randomized cross-over trial
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Outcome measures
| Measure |
Nurse-Administered Touch Intervention
n=16 Participants
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
|
Standard Care
n=16 Participants
Preterm infants will receive one episode of essential nursing care delivered as standard care.
|
|---|---|---|
|
Average Heart Rate -- During Intervention
|
172.6 beats per minute
Standard Deviation 10.5
|
168.6 beats per minute
Standard Deviation 9.2
|
PRIMARY outcome
Timeframe: recovery, 30 minutes after intervention delivery or control periodPopulation: 19 total infants participated in randomized cross-over trial
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Outcome measures
| Measure |
Nurse-Administered Touch Intervention
n=16 Participants
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
|
Standard Care
n=16 Participants
Preterm infants will receive one episode of essential nursing care delivered as standard care.
|
|---|---|---|
|
Average Heart Rate -- Recovery
|
161.7 beats per minute
Standard Deviation 10.0
|
158.6 beats per minute
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutesPopulation: 19 total participants in randomized cross-over trial
Spectral analysis of high-frequency heart rate variability averaged over the episode of caregiving during which infants received either the nurse-administered touch intervention or standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.
Outcome measures
| Measure |
Nurse-Administered Touch Intervention
n=16 Participants
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
|
Standard Care
n=16 Participants
Preterm infants will receive one episode of essential nursing care delivered as standard care.
|
|---|---|---|
|
Average High-frequency Heart Rate Variability -- During Caregiving Episode
|
3.2 ln(ms^2)
Interval 2.1 to 4.8
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3.2 ln(ms^2)
Interval 2.5 to 4.3
|
SECONDARY outcome
Timeframe: recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard carePopulation: 19 total participants in randomized cross-over trial
Spectral analysis of high-frequency heart rate variability averaged over the 30-minute period following caregiving that included the nurse-administered touch intervention or was delivered as standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.
Outcome measures
| Measure |
Nurse-Administered Touch Intervention
n=16 Participants
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
|
Standard Care
n=16 Participants
Preterm infants will receive one episode of essential nursing care delivered as standard care.
|
|---|---|---|
|
Average High-frequency Heart Rate Variability -- Recovery
|
3.0 ln(ms^2)
Interval 2.1 to 5.5
|
3.0 ln(ms^2)
Interval 2.3 to 4.9
|
SECONDARY outcome
Timeframe: during caregiving episode, approximately 20 minutesPopulation: 19 total participants in randomized cross-over trial
Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the caregiving episode that includes either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of caregiving.
Outcome measures
| Measure |
Nurse-Administered Touch Intervention
n=17 Participants
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
|
Standard Care
n=17 Participants
Preterm infants will receive one episode of essential nursing care delivered as standard care.
|
|---|---|---|
|
Average Frequency of Skin Conductance Responses -- During Caregiving Episode
|
0.14 waves per second
Standard Deviation 0.05
|
0.14 waves per second
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: recovery, 30 minutes after intervention delivery or control periodPopulation: 19 total participants in randomized cross-over trial
Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the 30-minute period following the caregiving episode that included either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of the 30-minute recovery period.
Outcome measures
| Measure |
Nurse-Administered Touch Intervention
n=17 Participants
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
|
Standard Care
n=16 Participants
Preterm infants will receive one episode of essential nursing care delivered as standard care.
|
|---|---|---|
|
Average Frequency of Skin Conductance Responses -- Recovery
|
0.06 waves per second
Standard Deviation 0.04
|
0.06 waves per second
Standard Deviation 0.05
|
Adverse Events
Nurse-Administered Touch Intervention
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nurse-Administered Touch Intervention
n=19 participants at risk
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.
Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
|
Standard Care
n=18 participants at risk
Preterm infants will receive one episode of essential nursing care delivered as standard care.
|
|---|---|---|
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General disorders
bradycardia or oxygen desaturation
|
26.3%
5/19 • Number of events 6 • Essential nursing care is scheduled to occur every 3 hours in the NICU. Study electrodes were attached to enrolled infants during the caregiving episode preceding the observed caregiving episode during which data collection occurred. Adverse events were documented from the time study electrodes were attached to the infant until the end of the 30-minute recovery period following the observed caregiving episode. Thus, total recording of adverse events was approximately 3.5 hours.
standard definition applied
|
44.4%
8/18 • Number of events 8 • Essential nursing care is scheduled to occur every 3 hours in the NICU. Study electrodes were attached to enrolled infants during the caregiving episode preceding the observed caregiving episode during which data collection occurred. Adverse events were documented from the time study electrodes were attached to the infant until the end of the 30-minute recovery period following the observed caregiving episode. Thus, total recording of adverse events was approximately 3.5 hours.
standard definition applied
|
Additional Information
Marliese D. Nist
The Ohio State University College of Nursing
Phone: 614-247-5781
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60