The Effect of Massage on Stress in Premature Babies

Not Applicable

Completed

• Conditions: Stress; Cortisol

• Registration Number: NCT05580874
• Lead Sponsor: Izmir Katip Celebi University

Brief Summary

The practices of the neonatal intensive care unit that reduce the stress of premature babies and respond to behavioral cues have a positive effect on the development of newborns. The stress experienced by premature infants affects the baby's behavior and laboratory findings. Massage is an effective application in facilitating the adaptation of premature babies to extrauterine life and ensuring that they are least affected by adverse environmental conditions. Massage in premature babies has an important place in reducing stress and supporting psychological, mental and physiological development as a healthy tactile stimulus.

Detailed Description

This study was planned to examine the effects of massage on stress behaviors and salivary cortisol levels in premature infants. The research was planned on a randomized controlled experimental. In the research, the group to which massage will be procedure is the experimental group, and the group to which the swaddling procedure will be the control group will form.

Study Timeline

• Study Start: 2022-06-17
• Study First Submitted: 2022-06-30
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-14
• Primary Completion: 2023-06-23
• Study Completion: 2023-06-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Families being voluntary to participate in the study
• Babies being born between 30 and 36 weeks plus 6 days of gestation
• Postnatal 3-5. premature babies between days
• Not taking analgesics or sedatives
• Absence of congenital anomaly
• Absence of skin disease
• The premature babies passing to oral feeding
• Not having a proven sepsis diagnosis
• No need for mechanical ventilator support

Exclusion Criteria

• Having a congenital anomaly
• Presence of skin disease
• Having intracranial bleeding
• Having sepsis
• Receiving phototherapy
• Taking analgesic / sedative type drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
"Newborn Stress Scale"	After the swaddling
Salivary cortisol levels	30 minutes after swaddling

Secondary Outcome Measures

Name	Time	Method
Baby's heart rate	A minutes after swaddling
Baby's oxygen saturation	A minutes after swaddling
Baby's respiratory rate	A minutes after swaddling
Baby's body temperature	A minutes after swaddling

Trial Locations

Locations (1)

Tepecik Training and Research Hospital; 🇹🇷 İzmir, Turkey