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The Effects of The Use of Baby Mobile Accompanied With Brahms Lullaby On The Infants During Sternum Dressing

Primary Purpose

Pain, Procedural (During Sternum Dressing on Infants), Physiological Parameters During Sternum Dressing in Babies

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Procedural (During Sternum Dressing on Infants) focused on measuring Sternum Dressing, Infant, Brahms Lullaby, Baby Mobile, Pain, Physiological Parameters

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Pediatric Cardiovascular Surgery Intensice Care Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABIES GROUP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's pain levels during sternum dressing
FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Bad) to 10 (Good)).
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's heart beat during sternum dressing
heart beat- bpm
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's blood pressure sternum dressing
blood pressure- mmHg
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's body temperature during sternum dressing
body temperature-- degrees centigrade
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing
SpO2

Secondary Outcome Measures

Full Information

First Posted
May 10, 2021
Last Updated
May 18, 2021
Sponsor
Okan University
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1. Study Identification

Unique Protocol Identification Number
NCT04894487
Brief Title
The Effects of The Use of Baby Mobile Accompanied With Brahms Lullaby On The Infants During Sternum Dressing
Official Title
The Effect of The Use of Baby Mobile Accompanied With Brhams Lullaby On The Infant's Physiologicak Parameters and Pain Level During Sternum Dressing
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural (During Sternum Dressing on Infants), Physiological Parameters During Sternum Dressing in Babies
Keywords
Sternum Dressing, Infant, Brahms Lullaby, Baby Mobile, Pain, Physiological Parameters

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled two groups ( control group and experiment group)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABIES GROUP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY
Intervention Description
Using of baby mobile and listening Brahms Lullaby during sternum dressing process
Primary Outcome Measure Information:
Title
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's pain levels during sternum dressing
Description
FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Bad) to 10 (Good)).
Time Frame
30 minutes
Title
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's heart beat during sternum dressing
Description
heart beat- bpm
Time Frame
30 minutes
Title
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's blood pressure sternum dressing
Description
blood pressure- mmHg
Time Frame
30 minutes
Title
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's body temperature during sternum dressing
Description
body temperature-- degrees centigrade
Time Frame
30 minutes
Title
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing
Description
SpO2
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Facility Information:
Facility Name
Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Pediatric Cardiovascular Surgery Intensice Care Unit
City
Küçükçekmece
State/Province
Istanbul
ZIP/Postal Code
34303
Country
Turkey

12. IPD Sharing Statement

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The Effects of The Use of Baby Mobile Accompanied With Brahms Lullaby On The Infants During Sternum Dressing

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