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

Not Applicable

Completed

• Conditions: Pain, Procedural (During Sternum Dressing on Infants); Physiological Parameters During Sternum Dressing in Babies
• Interventions: Behavioral: THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY

• Registration Number: NCT04894487
• Lead Sponsor: Okan University

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".

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-25
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2021-05
• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-18
• Last Update Submitted: 2021-05-18
• Study First Posted: 2021-05-20
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABIES GROUP	THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY	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.

Primary Outcome Measures

Name	Time	Method
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's pain levels during sternum dressing	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)).
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing	30 minutes	SpO2
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's blood pressure sternum dressing	30 minutes	blood pressure- mmHg
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's heart beat during sternum dressing	30 minutes	heart beat- bpm
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's body temperature during sternum dressing	30 minutes	body temperature-- degrees centigrade

Trial Locations

Locations (1)

Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Pediatric Cardiovascular Surgery Intensice Care Unit; 🇹🇷 Küçükçekmece, Istanbul, Turkey