The Effect of Massage on Stress in Premature Babies

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress, Cortisol

Intervention / Treatment
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* Other: Massage
* Other: Swaddling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Massage group<br>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<br>* The babies in the massage group were given a massage once a day.<br>|
| Other: Control group<br>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<br>* Control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Baby's respiratory rate |  | 5th minute of the massage | 
| Baby's oxygen saturation |  | 5th minute of the massage | 
| Baby's body temperature |  | 5th minute of the massage | 
| Baby's heart rate |  | A minutes after massage | 
| Baby's respiratory rate |  | A minutes after massage | 
| Baby's oxygen saturation |  | A minutes after massage | 
| Baby's body temperature |  | A minutes after massage | 
| Baby's heart rate |  | A minutes before swaddling | 
| Baby's respiratory rate |  | A minutes before swaddling | 
| Baby's oxygen saturation |  | A minutes before swaddling | 
| Baby's body temperature |  | A minutes before swaddling | 
| Baby's heart rate |  | In the fifth minute of the swaddling | 
| Baby's respiratory rate |  | 5th minute of the swaddling | 
| Baby's oxygen saturation |  | 5th minute of the swaddling | 
| Baby's body temperature |  | 5th minute of the swaddling | 
| Baby's heart rate |  | A minutes after swaddling | 
| Baby's respiratory rate |  | A minutes after swaddling | 
| Baby's oxygen saturation |  | A minutes after swaddling | 
| Baby's body temperature |  | A minutes after swaddling | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage, Premature, Stress