The Effects of The Use of Baby Mobile Accompanied With Brahms Lullaby On The Infants During Sternum Dressing
May 18, 2021 updated by: Kamil KARAKAYA, Okan University
The Effect of The Use of Baby Mobile Accompanied With Brhams Lullaby On The Infant's Physiologicak Parameters and Pain Level During Sternum Dressing
The study was conducted experimentally in a randomized controlled manner in order to determine the effect of the use of baby mobile accompanied by Brahms Lullaby on physiological parameters and pain level during sternum dressing in babies.
The research was carried out with 76 babies followed up in the Pediatric Cardiovascular Surgery Intensive Care Unit between August 2020 and February 2021 (Baby Mobile Group accompanied by Brahms Lullaby: 38, Control Group: 38).
Data were collected by using the "Baby Monitoring Form" and "FLACC Pain Scale".
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Istanbul
-
Küçükçekmece, Istanbul, Turkey, 34303
- Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Pediatric Cardiovascular Surgery Intensice Care Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being 1-12 months
- Being volunteer for research
- Operated for Congenital Heart Disease
- Got Sternum incision
- No other chronic illness
- No similar surgical experiment before
- No visual impairment
- No hearing impairment
- No mental or neurological impairment
- Hospitalization experience
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
The babies have got sternum incision after the pediatric cardiac surgery.
Experiment is about the dressing of the sternum incision.
There is no extra intervention during sternum dressing at control group like routine of pediatric cardiovascular surgery intensive care clinic.
Saved pain scores and physiological parameters and pain scores; just before the sternum dressing, just after sternum dressing and after the 15 minutes sternum dressing.
|
|
|
Experimental: THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABIES GROUP
Baby mobile and Brahms Lullaby started before the 10 minutes of sternum dressing process and controlled permanence of the baby mobile and Brahms Lullaby during sternum dressing.
Saved pain scores and physiological parameters and pain scores; just before the sternum dressing, just after sternum dressing and after the 15 minutes sternum dressing.
|
Using of baby mobile and listening Brahms Lullaby during sternum dressing process
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's pain levels during sternum dressing
Time Frame: 30 minutes
|
FLACC Pain Scale was used for determain pain level in this research.
Scale got 0 to 10 points (0 (Bad) to 10 (Good)).
|
30 minutes
|
|
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's heart beat during sternum dressing
Time Frame: 30 minutes
|
heart beat- bpm
|
30 minutes
|
|
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's blood pressure sternum dressing
Time Frame: 30 minutes
|
blood pressure- mmHg
|
30 minutes
|
|
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's body temperature during sternum dressing
Time Frame: 30 minutes
|
body temperature-- degrees centigrade
|
30 minutes
|
|
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing
Time Frame: 30 minutes
|
SpO2
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2020
Primary Completion (Actual)
February 28, 2021
Study Completion (Actual)
February 28, 2021
Study Registration Dates
First Submitted
May 10, 2021
First Submitted That Met QC Criteria
May 18, 2021
First Posted (Actual)
May 20, 2021
Study Record Updates
Last Update Posted (Actual)
May 20, 2021
Last Update Submitted That Met QC Criteria
May 18, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15761188
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.