Pilot Study of Nursing Touch and Biobehavioral Stress

Not Applicable

Completed

• Conditions: Stress Reaction; Prematurity
• Interventions: Behavioral: Nurse-Administered Touch Intervention

• Registration Number: NCT05030233
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-01
• Study Start: 2021-09-10
• Primary Completion: 2022-04-20
• Study Completion: 2022-05-17
• Results First Submitted: 2024-12-12
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Results First Posted: 2025-02-18
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nurse-Administered Touch Intervention	Nurse-Administered Touch Intervention	Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.

Primary Outcome Measures

Name	Time	Method
Average Heart Rate -- During Intervention	during intervention or control period, approximately 20 minutes	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	recovery, 30 minutes after intervention delivery or control period	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

Name	Time	Method
Average High-frequency Heart Rate Variability -- During Caregiving Episode	during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes	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.
Average High-frequency Heart Rate Variability -- Recovery	recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care	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.
Average Frequency of Skin Conductance Responses -- During Caregiving Episode	during caregiving episode, approximately 20 minutes	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.
Average Frequency of Skin Conductance Responses -- Recovery	recovery, 30 minutes after intervention delivery or control period	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States