Pilot Study of Nursing Touch and Biobehavioral Stress (P-NAT-BIO)

Pilot Study of Nurse-Administered Touch and Biobehavioral Stress Responses of Preterm Infants

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.

Study Overview

• Status: Completed
• Conditions: Prematurity; Stress Reaction
• Intervention / Treatment: Behavioral: Nurse-Administered Touch Intervention

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse-Administered Touch Intervention; Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.	Behavioral: 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.
No Intervention: Standard Care; Preterm infants will receive one episode of essential nursing care delivered as standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during intervention or control period, approximately 20 minutes
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	recovery, 30 minutes after intervention delivery or control period

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurobehavior	neurobehavior will be assessed using the Neurobehavioral Assessment of the Preterm Infant when infants reach 35 weeks post-menstrual age	35 weeks post-menstrual age
Anderson Behavioral State Scale	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	recovery, 30 minutes after intervention delivery or control period

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Nationwide Children's Hospital
• Investigators: Principal Investigator: Marliese D. Nist, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: stress; preterm infant; nursing care; touch
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Stress
• Other Study ID Numbers: 2021N0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No