Back to resultsPilot Study of Nursing Touch and Biobehavioral Stress (P-NAT-BIO)
Primary Purpose
Prematurity, Stress Reaction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse-Administered Touch Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Prematurity focused on measuring preterm infant, stress, nursing care, touch
Eligibility Criteria
Inclusion Criteria:
- Born prematurely between 27 and 30 weeks post-menstrual age.
- Born to mothers who are English-speaking and able to provide informed consent.
- No more than 10 days old at the time of enrollment.
Exclusion Criteria:
- Diagnosed with Grade III/IV intraventricular hemorrhage or other neurologic abnormality (e.g. seizure disorder) affecting sensory perception or motor function.
- Diagnosed with a congenital anomaly requiring surgery during the neonatal period.
- Receiving scheduled steroids or vasopressors.
- Skin conditions that preclude the attachment of sensors.
- Diagnosed with Neonatal Abstinence Syndrome or born to mothers with known illicit drug use, except marijuana, during pregnancy.
- Diagnosed with chromosomal abnormalities.
- Requiring special isolation with universal gloving for potentially infectious pathogens.
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nurse-Administered Touch Intervention
Standard Care
Arm Description
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.
Preterm infants will receive one episode of essential nursing care delivered as standard care.
Outcomes
Primary Outcome Measures
Average heart rate -- during intervention
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Average heart rate -- recovery
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Secondary Outcome Measures
Average heart rate variability -- during intervention
high frequency heart rate variability averaged over the intervention or control period
Average heart rate variability -- recovery
high frequency heart rate variability averaged over the intervention or control period
Average skin conductance responses -- during intervention
skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the intervention or control period
Average skin conductance responses -- recovery
skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the intervention or control period
Salivary cortisol
saliva will be collected using cellulose surgical sponges and quantified by enzyme-linked immunosorbent assay
Salivary cortisol -- recovery
saliva will be collected using cellulose surgical sponges and quantified by enzyme-linked immunosorbent assay
Full Information
NCT ID
NCT05030233
First Posted
August 23, 2021
Last Updated
May 19, 2022
Sponsor
Ohio State University
Collaborators
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05030233
Brief Title
Pilot Study of Nursing Touch and Biobehavioral Stress
Acronym
P-NAT-BIO
Official Title
Pilot Study of Nurse-Administered Touch and Biobehavioral Stress Responses of Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
May 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Nationwide Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized cross-over clinical trial to determine the effect of a nurse-administered comforting touch intervention on the biobehavioral stress responses of preterm infants hospitalized in the neonatal intensive care unit.
Detailed Description
Preterm infants will receive one episode of essential nursing care as standard care and one episode of essential nursing care that includes a nurse-administered comforting touch intervention approximately 24 hours apart in a randomized sequence. For 10 minutes prior to the start of the two observed care episodes, during the care episodes, and for 60 minutes after the conclusion of the care episodes, researchers will measure infants' biobehavioral stress responses. When infants reach 35 weeks post-menstrual age, researchers will perform a neurobehavioral assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Stress Reaction
Keywords
preterm infant, stress, nursing care, touch
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized cross-over design
Masking
None (Open Label)
Masking Description
The statistician performing the data analysis will be blinded to group.
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nurse-Administered Touch Intervention
Arm Type
Experimental
Arm Description
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Preterm infants will receive one episode of essential nursing care delivered as standard care.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-Administered Touch Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average heart rate -- during intervention
Description
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Time Frame
during intervention or control period, approximately 20 minutes
Title
Average heart rate -- recovery
Description
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Time Frame
recovery, 30 minutes after intervention delivery or control period
Secondary Outcome Measure Information:
Title
Average heart rate variability -- during intervention
Description
high frequency heart rate variability averaged over the intervention or control period
Time Frame
during intervention or control period, approximately 20 minutes
Title
Average heart rate variability -- recovery
Description
high frequency heart rate variability averaged over the intervention or control period
Time Frame
recovery, 30 minutes after intervention delivery or control period
Title
Average skin conductance responses -- during intervention
Description
skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the intervention or control period
Time Frame
during intervention or control period, approximately 20 minutes
Title
Average skin conductance responses -- recovery
Description
skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the intervention or control period
Time Frame
recovery, 30 minutes after intervention delivery or control period
Title
Salivary cortisol
Description
saliva will be collected using cellulose surgical sponges and quantified by enzyme-linked immunosorbent assay
Time Frame
immediately after intervention or control period
Title
Salivary cortisol -- recovery
Description
saliva will be collected using cellulose surgical sponges and quantified by enzyme-linked immunosorbent assay
Time Frame
recovery, 60 minutes after intervention delivery or control period
Other Pre-specified Outcome Measures:
Title
neurobehavior
Description
neurobehavior will be assessed using the Neurobehavioral Assessment of the Preterm Infant when infants reach 35 weeks post-menstrual age
Time Frame
35 weeks post-menstrual age
Title
Anderson Behavioral State Scale
Description
behavioral states (ranging from quiet sleep to crying) will be measured during the recovery period as a further behavioral measure of infant recovery from essential nursing care
Time Frame
recovery, 30 minutes after intervention delivery or control period
10. Eligibility
Sex
All
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Born prematurely between 27 and 30 weeks post-menstrual age.
Born to mothers who are English-speaking and able to provide informed consent.
No more than 10 days old at the time of enrollment.
Exclusion Criteria:
Diagnosed with Grade III/IV intraventricular hemorrhage or other neurologic abnormality (e.g. seizure disorder) affecting sensory perception or motor function.
Diagnosed with a congenital anomaly requiring surgery during the neonatal period.
Receiving scheduled steroids or vasopressors.
Skin conditions that preclude the attachment of sensors.
Diagnosed with Neonatal Abstinence Syndrome or born to mothers with known illicit drug use, except marijuana, during pregnancy.
Diagnosed with chromosomal abnormalities.
Requiring special isolation with universal gloving for potentially infectious pathogens.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marliese D. Nist, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pilot Study of Nursing Touch and Biobehavioral Stress
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