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NCT05580874 Clinical Trial

The Effect of Massage on Stress in Premature Babies

Stress Clinical Trial

Official title:
Investigation of the Effect of Massage on Stress Behaviors and Salivary Cortisol Levels in Premature Babies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05580874
Other study ID # 22-1.1T/54
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 17, 2022
Est. completion date June 23, 2023

Study information
Verified date May 2024
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 23, 2023
Est. primary completion date June 23, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Weeks to 37 Weeks
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Massage
The babies in the massage group were given a massage once a day.
• Swaddling
Control group

Locations
Country Name City State
Turkey Tepecik Training and Research Hospital Izmir

Sponsors (3)
Lead Sponsor Collaborator
Izmir Katip Celebi University Ege University, Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Salivary cortisol levels 5 minutes before massage
Primary Salivary cortisol levels 5 minutes before swaddling
Primary Salivary cortisol levels 30 minutes after massage
Primary Salivary cortisol levels 30 minutes after swaddling
Primary "Newborn Stress Scale" After the massage
Primary "Newborn Stress Scale" After the swaddling
Secondary Baby's heart rate A minutes before massage
Secondary Baby's respiratory rate A minutes before massage
Secondary Baby's oxygen saturation A minutes before massage
Secondary Baby's body temperature A minutes before massage
Secondary Baby's heart rate 5th minute of the massage
Secondary Baby's respiratory rate 5th minute of the massage
Secondary Baby's oxygen saturation 5th minute of the massage
Secondary Baby's body temperature 5th minute of the massage
Secondary Baby's heart rate A minutes after massage
Secondary Baby's respiratory rate A minutes after massage
Secondary Baby's oxygen saturation A minutes after massage
Secondary Baby's body temperature A minutes after massage
Secondary Baby's heart rate A minutes before swaddling
Secondary Baby's respiratory rate A minutes before swaddling
Secondary Baby's oxygen saturation A minutes before swaddling
Secondary Baby's body temperature A minutes before swaddling
Secondary Baby's heart rate In the fifth minute of the swaddling
Secondary Baby's respiratory rate 5th minute of the swaddling
Secondary Baby's oxygen saturation 5th minute of the swaddling
Secondary Baby's body temperature 5th minute of the swaddling
Secondary Baby's heart rate A minutes after swaddling
Secondary Baby's respiratory rate A minutes after swaddling
Secondary Baby's oxygen saturation A minutes after swaddling
Secondary Baby's body temperature A minutes after swaddling
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