Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-06-17
2023-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Massage group
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.
Massage
The babies in the massage group were given a massage once a day.
Control group
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.
Swaddling
Control group
Interventions
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Massage
The babies in the massage group were given a massage once a day.
Swaddling
Control group
Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of skin disease
* Having intracranial bleeding
* Having sepsis
* Receiving phototherapy
* Taking analgesic / sedative type drugs
30 Weeks
37 Weeks
ALL
No
Sponsors
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Tepecik Training and Research Hospital
OTHER
Ege University
OTHER
Izmir Katip Celebi University
OTHER
Responsible Party
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Pınar Dogan
RN, MSc
Principal Investigators
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Hatice BAL YILMAZ, Prof.
Role: STUDY_DIRECTOR
Ege University
Pınar DOGAN
Role: PRINCIPAL_INVESTIGATOR
Izmir Katip Celebi University
Locations
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Tepecik Training and Research Hospital
Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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22-1.1T/54
Identifier Type: -
Identifier Source: org_study_id
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