Pilot Study of Nursing Touch and Biobehavioral Stress

NCT05030233 | Completed Results DMC

• 1 other identifier: 2021N0006
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Stress Reaction

Keywords

preterm infant; stress; nursing care; touch

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• Average High-frequency Heart Rate Variability -- Recovery

  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

  during caregiving episode, approximately 20 minutes

• Average Frequency of Skin Conductance Responses -- Recovery

  recovery, 30 minutes after intervention delivery or control period

Study Arms (2)

Nurse-Administered Touch Intervention

EXPERIMENTAL

Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.

Behavioral: Nurse-Administered Touch Intervention

Standard Care

NO INTERVENTION

Preterm infants will receive one episode of essential nursing care delivered as standard care.

Interventions

Nurse-Administered Touch Intervention BEHAVIORAL

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.

Nurse-Administered Touch Intervention

Eligibility Criteria

• Age: Up to 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Premature Birth; Fractures, Stress

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fractures, Bone; Wounds and Injuries

Results Point of Contact

• Title: Marliese D. Nist
• Organization: The Ohio State University College of Nursing

nist.10@osu.edu

614-247-5781

Study Officials

• Marliese D. Nist, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistician performing the data analysis will be blinded to group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomized cross-over design

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 1, 2021
• Study Start: September 10, 2021
• Primary Completion: April 20, 2022
• Study Completion: May 17, 2022
• Last Updated: February 18, 2025
• Results First Posted: February 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)