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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cortisol
• Premature Birth
• Stress

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