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

  • Turkey
    • 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.
Behavioral: THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY
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

Okan University

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

Keywords

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.

Clinical Trials on Pain, Procedural (During Sternum Dressing on Infants)

Clinical Trials on THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe