The Effect of Massage on Stress in Premature Babies

Sponsor
Izmir Katip Celebi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05580874
Collaborator
Tepecik Training and Research Hospital (Other), Ege University (Other)
40
1
2
29.5
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Massage
  • Other: Swaddling
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Investigation of the Effect of Massage on Stress Behaviors and Salivary Cortisol Levels in Premature Babies
Actual Study Start Date :
Jun 17, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Massage group

Babies in the massage group will be given a five-minute massage once a day, one hour after the morning feeding (between 9.30-11.30 am). Before, during and after the massage procedure, the video will be recorded to observe the stress behavior of the babies. 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
The babies in the massage group were given a massage once a day.

Other: Control group

Babies 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. Babies will be swaddling for five 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
Control group

Outcome Measures

Primary Outcome Measures

  1. Salivary cortisol levels [5 minutes before massage]

  2. Salivary cortisol levels [5 minutes before swaddling]

  3. Salivary cortisol levels [30 minutes after massage]

  4. Salivary cortisol levels [30 minutes after swaddling]

  5. "Newborn Stress Scale" [After the massage]

  6. "Newborn Stress Scale" [After the swaddling]

Secondary Outcome Measures

  1. Baby's heart rate [A minutes before massage]

  2. Baby's respiratory rate [A minutes before massage]

  3. Baby's oxygen saturation [A minutes before massage]

  4. Baby's body temperature [A minutes before massage]

  5. Baby's heart rate [5th minute of the massage]

  6. Baby's respiratory rate [5th minute of the massage]

  7. Baby's oxygen saturation [5th minute of the massage]

  8. Baby's body temperature [5th minute of the massage]

  9. Baby's heart rate [A minutes after massage]

  10. Baby's respiratory rate [A minutes after massage]

  11. Baby's oxygen saturation [A minutes after massage]

  12. Baby's body temperature [A minutes after massage]

  13. Baby's heart rate [A minutes before swaddling]

  14. Baby's respiratory rate [A minutes before swaddling]

  15. Baby's oxygen saturation [A minutes before swaddling]

  16. Baby's body temperature [A minutes before swaddling]

  17. Baby's heart rate [In the fifth minute of the swaddling]

  18. Baby's respiratory rate [5th minute of the swaddling]

  19. Baby's oxygen saturation [5th minute of the swaddling]

  20. Baby's body temperature [5th minute of the swaddling]

  21. Baby's heart rate [A minutes after swaddling]

  22. Baby's respiratory rate [A minutes after swaddling]

  23. Baby's oxygen saturation [A minutes after swaddling]

  24. Baby's body temperature [A minutes after swaddling]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Weeks to 38 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Families being voluntary to participate in the study

  • Babies being born between 30 and 37 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tepecik Training and Research Hospital İzmir Turkey

Sponsors and Collaborators

  • Izmir Katip Celebi University
  • Tepecik Training and Research Hospital
  • Ege University

Investigators

  • Study Director: Hatice BAL YILMAZ, Prof., Ege University
  • Principal Investigator: Pınar DOGAN, Izmir Katip Celebi University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pınar Dogan, RN, MSc, Izmir Katip Celebi University
ClinicalTrials.gov Identifier:
NCT05580874
Other Study ID Numbers:
  • 22-1.1T/54
First Posted:
Oct 14, 2022
Last Update Posted:
Oct 14, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pınar Dogan, RN, MSc, Izmir Katip Celebi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2022