Clinical trial NCT05580874: The Effect of Massage on Stress in Premature Babies
Official title: Investigation of the Effect of Massage on Stress Behaviors and Salivary Cortisol Levels in Premature Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Cortisol
Keywords: Massage
Premature
Stress
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Tepecik Training and Research Hospital
name: Ege University
First posted: 2022-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Salivary cortisol levels
timeFrame: 5 minutes before massage
measure: Salivary cortisol levels
timeFrame: 5 minutes before swaddling
measure: Salivary cortisol levels
timeFrame: 30 minutes after massage
measure: Salivary cortisol levels
timeFrame: 30 minutes after swaddling
measure: "Newborn Stress Scale"
timeFrame: After the massage
measure: "Newborn Stress Scale"
timeFrame: After the swaddling
Secondary outcomes:
measure: Baby's heart rate
timeFrame: A minutes before massage
measure: Baby's respiratory rate
timeFrame: A minutes before massage
measure: Baby's oxygen saturation
timeFrame: A minutes before massage
measure: Baby's body temperature
timeFrame: A minutes before massage
measure: Baby's heart rate
timeFrame: 5th minute of the massage
measure: Baby's respiratory rate
timeFrame: 5th minute of the massage
measure: Baby's oxygen saturation
timeFrame: 5th minute of the massage
measure: Baby's body temperature
timeFrame: 5th minute of the massage
measure: Baby's heart rate
timeFrame: A minutes after massage
measure: Baby's respiratory rate
timeFrame: A minutes after massage
measure: Baby's oxygen saturation
timeFrame: A minutes after massage
measure: Baby's body temperature
timeFrame: A minutes after massage
measure: Baby's heart rate
timeFrame: A minutes before swaddling
measure: Baby's respiratory rate
timeFrame: A minutes before swaddling
measure: Baby's oxygen saturation
timeFrame: A minutes before swaddling
measure: Baby's body temperature
timeFrame: A minutes before swaddling
measure: Baby's heart rate
timeFrame: In the fifth minute of the swaddling
measure: Baby's respiratory rate
timeFrame: 5th minute of the swaddling
measure: Baby's oxygen saturation
timeFrame: 5th minute of the swaddling
measure: Baby's body temperature
timeFrame: 5th minute of the swaddling
measure: Baby's heart rate
timeFrame: A minutes after swaddling
measure: Baby's respiratory rate
timeFrame: A minutes after swaddling
measure: Baby's oxygen saturation
timeFrame: A minutes after swaddling
measure: Baby's body temperature
timeFrame: A minutes after swaddling
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Tepecik Training and Research Hospital
Study officials:
affiliation: Ege University
name: Hatice BAL YILMAZ, Prof.
role: STUDY_DIRECTOR
affiliation: Izmir Katip Celebi University
name: Pınar DOGAN
role: PRINCIPAL_INVESTIGATOR
References: