The Effect of Massage on Stress in Premature Babies

NCT05580874 | Completed

• 1 other identifier: 22-1.1T/54
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Cortisol

Keywords

Massage; Premature; Stress

Outcome Measures

Primary Outcomes (6)

• Salivary cortisol levels

  5 minutes before massage

• Salivary cortisol levels

  5 minutes before swaddling

• Salivary cortisol levels

  30 minutes after massage

• Salivary cortisol levels

  30 minutes after swaddling

• "Newborn Stress Scale"

  After the massage

• "Newborn Stress Scale"

  After the swaddling

Secondary Outcomes (24)

• Baby's heart rate

  A minutes before massage

• Baby's respiratory rate

  A minutes before massage

• Baby's oxygen saturation

  A minutes before massage

• Baby's body temperature

  A minutes before massage

• Baby's heart rate

  5th minute of the massage

Study Arms (2)

Massage group

EXPERIMENTAL

Infants in the massage group received a ten-minute massage once a day, one hour after the morning feeding (between 9.30-11.30 am). Video recordings were made to observe the stress behaviors of the infants before, during and after the massage. Vital signs will be recorded a minute before the starting of the massage, at fifth minutes during the procedure and a minute after the end of the massage, and a video will be recorded during these processes. A saliva cortisol sample will be taken the massage five minutes before and 30 minutes after the massage. The scores given to the "Newborn Stress Scale" will be evaluated by watching the videos recorded after the procedure by experts in the field.

Other: Massage

Control group

OTHER

Infants in the swaddling group will form the control group. The swaddling process will be done one hour after the babies are feding (between 9.30-11.30 am). Before, during and after the swaddling procedure, the video will be recorded to observe the stress behavior of the babies. A minute before swaddling, video recording will start. Infants will be swaddling for ten minutes and video recording will be continue. After this process, a minute video recording will be made while the baby is not swaddling. Vital signs will be recorded one minute before starting the swaddling at fifth minutes during the procedure, and a minute after the swaddling. A saliva cortisol sample will be taken five minutes before and 30 minutes after the swaddling. The scores given to the "Newborn Stress Scale" will be evaluated by watching the videos recorded after the procedure by experts in the field.

Other: Swaddling

Interventions

Massage OTHER

The babies in the massage group were given a massage once a day.

Massage group

Swaddling OTHER

Control group

Control group

Eligibility Criteria

• Age: 30 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Tepecik Training and Research Hospital: collaborator
• Ege University: collaborator

Study Sites (1)

Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Massage

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Hatice BAL YILMAZ, Prof.

  Ege University

  STUDY DIRECTOR

• Pınar DOGAN

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, MSc

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: October 14, 2022
• Study Start: June 17, 2022
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)