NCT05030233

Pilot Study of Nursing Touch and Biobehavioral Stress

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 10 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity
• Stress Reaction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-10
• Primary completion: 2022-04-20
• Completion: 2022-05-17
• First posted: 2021-09-01
• Last updated: 2025-02-18
• Results posted: 2025-02-18

Locations

1 site across 1 country: United States