Back to resultsThe Effect of Massage on Stress in Premature Babies
Primary Purpose
Stress, Cortisol
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Massage
Swaddling
Sponsored by
About this trial
This is an interventional supportive care trial for Stress focused on measuring Massage, Premature, Stress
Eligibility Criteria
Inclusion Criteria:
- Families being voluntary to participate in the study
- Babies being born between 30 and 37 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
Sites / Locations
- Tepecik Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Massage group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Salivary cortisol levels
Salivary cortisol levels
Salivary cortisol levels
Salivary cortisol levels
"Newborn Stress Scale"
"Newborn Stress Scale"
Secondary Outcome Measures
Baby's heart rate
Baby's respiratory rate
Baby's oxygen saturation
Baby's body temperature
Baby's heart rate
Baby's respiratory rate
Baby's oxygen saturation
Baby's body temperature
Baby's heart rate
Baby's respiratory rate
Baby's oxygen saturation
Baby's body temperature
Baby's heart rate
Baby's respiratory rate
Baby's oxygen saturation
Baby's body temperature
Baby's heart rate
Baby's respiratory rate
Baby's oxygen saturation
Baby's body temperature
Baby's heart rate
Baby's respiratory rate
Baby's oxygen saturation
Baby's body temperature
Full Information
NCT ID
NCT05580874
First Posted
June 30, 2022
Last Updated
September 19, 2023
Sponsor
Izmir Katip Celebi University
Collaborators
Tepecik Training and Research Hospital, Ege University
1. Study Identification
Unique Protocol Identification Number
NCT05580874
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University
Collaborators
Tepecik Training and Research Hospital, Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Cortisol
Keywords
Massage, Premature, Stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Massage group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
The babies in the massage group were given a massage once a day.
Intervention Type
Other
Intervention Name(s)
Swaddling
Intervention Description
Control group
Primary Outcome Measure Information:
Title
Salivary cortisol levels
Time Frame
5 minutes before massage
Title
Salivary cortisol levels
Time Frame
5 minutes before swaddling
Title
Salivary cortisol levels
Time Frame
30 minutes after massage
Title
Salivary cortisol levels
Time Frame
30 minutes after swaddling
Title
"Newborn Stress Scale"
Time Frame
After the massage
Title
"Newborn Stress Scale"
Time Frame
After the swaddling
Secondary Outcome Measure Information:
Title
Baby's heart rate
Time Frame
A minutes before massage
Title
Baby's respiratory rate
Time Frame
A minutes before massage
Title
Baby's oxygen saturation
Time Frame
A minutes before massage
Title
Baby's body temperature
Time Frame
A minutes before massage
Title
Baby's heart rate
Time Frame
5th minute of the massage
Title
Baby's respiratory rate
Time Frame
5th minute of the massage
Title
Baby's oxygen saturation
Time Frame
5th minute of the massage
Title
Baby's body temperature
Time Frame
5th minute of the massage
Title
Baby's heart rate
Time Frame
A minutes after massage
Title
Baby's respiratory rate
Time Frame
A minutes after massage
Title
Baby's oxygen saturation
Time Frame
A minutes after massage
Title
Baby's body temperature
Time Frame
A minutes after massage
Title
Baby's heart rate
Time Frame
A minutes before swaddling
Title
Baby's respiratory rate
Time Frame
A minutes before swaddling
Title
Baby's oxygen saturation
Time Frame
A minutes before swaddling
Title
Baby's body temperature
Time Frame
A minutes before swaddling
Title
Baby's heart rate
Time Frame
In the fifth minute of the swaddling
Title
Baby's respiratory rate
Time Frame
5th minute of the swaddling
Title
Baby's oxygen saturation
Time Frame
5th minute of the swaddling
Title
Baby's body temperature
Time Frame
5th minute of the swaddling
Title
Baby's heart rate
Time Frame
A minutes after swaddling
Title
Baby's respiratory rate
Time Frame
A minutes after swaddling
Title
Baby's oxygen saturation
Time Frame
A minutes after swaddling
Title
Baby's body temperature
Time Frame
A minutes after swaddling
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pınar DOGAN
Phone
00902323293535
Email
dgnn.pinarr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hatice BAL YILMAZ, Prof.
Phone
00902323115503
Email
haticebalyilmaz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice BAL YILMAZ, Prof.
Organizational Affiliation
Ege University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pınar DOGAN
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tepecik Training and Research Hospital
City
İzmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pınar DOGAN
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Massage on Stress in Premature Babies
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