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The Effect of Massage on Stress in Premature Babies

I

Izmir Katip Celebi University

Status

Completed

Conditions

Cortisol
Stress

Treatments

Other: Swaddling
Other: Massage

Study type

Interventional

Funder types

Other

Identifiers

NCT05580874
22-1.1T/54

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

30 to 37 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Massage group
Experimental group
Description:
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.
Treatment:
Other: Massage
Control group
Other group
Description:
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.
Treatment:
Other: Swaddling

Trial contacts and locations

1

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Central trial contact

Pınar DOGAN; Hatice BAL YILMAZ, Prof.

Data sourced from clinicaltrials.gov

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