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Completed

NCT Number: NCT05580874

The Effect of Massage on Stress in Premature Babies

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.

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Key information

Conditions

Stress Cortisol Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

30 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage

Other

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

Swaddling

Other

Control group

Primary outcomes

  1. Salivary cortisol levels

    Time frame: 5 minutes before massage

  2. Salivary cortisol levels

    Time frame: 5 minutes before swaddling

  3. Salivary cortisol levels

    Time frame: 30 minutes after massage

  4. Salivary cortisol levels

    Time frame: 30 minutes after swaddling

  5. "Newborn Stress Scale"

    Time frame: After the massage

  6. "Newborn Stress Scale"

    Time frame: After the swaddling

Secondary outcomes

  1. Baby's heart rate

    Time frame: A minutes before massage

  2. Baby's respiratory rate

    Time frame: A minutes before massage

  3. Baby's oxygen saturation

    Time frame: A minutes before massage

  4. Baby's body temperature

    Time frame: A minutes before massage

  5. Baby's heart rate

    Time frame: 5th minute of the massage

  6. Baby's respiratory rate

    Time frame: 5th minute of the massage

  7. Baby's oxygen saturation

    Time frame: 5th minute of the massage

  8. Baby's body temperature

    Time frame: 5th minute of the massage

  9. Baby's heart rate

    Time frame: A minutes after massage

  10. Baby's respiratory rate

    Time frame: A minutes after massage

  11. Baby's oxygen saturation

    Time frame: A minutes after massage

  12. Baby's body temperature

    Time frame: A minutes after massage

  13. Baby's heart rate

    Time frame: A minutes before swaddling

  14. Baby's respiratory rate

    Time frame: A minutes before swaddling

  15. Baby's oxygen saturation

    Time frame: A minutes before swaddling

  16. Baby's body temperature

    Time frame: A minutes before swaddling

  17. Baby's heart rate

    Time frame: In the fifth minute of the swaddling

  18. Baby's respiratory rate

    Time frame: 5th minute of the swaddling

  19. Baby's oxygen saturation

    Time frame: 5th minute of the swaddling

  20. Baby's body temperature

    Time frame: 5th minute of the swaddling

  21. Baby's heart rate

    Time frame: A minutes after swaddling

  22. Baby's respiratory rate

    Time frame: A minutes after swaddling

  23. Baby's oxygen saturation

    Time frame: A minutes after swaddling

  24. Baby's body temperature

    Time frame: A minutes after swaddling

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Collaborators

  • Ege University
  • Tepecik Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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