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Pilot Study of Nursing Touch and Biobehavioral Stress

NCT05030233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-02-18

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

  • Marliese D. Nist, PhD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-10
Primary Completion
2022-04-20
Completion
2022-05-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05030233 on ClinicalTrials.gov