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Completed

NCT Number: NCT04894487

The Effects of The Use of Baby Mobile Accompanied With Brahms Lullaby On The Infants 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".

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Key information

Conditions

Pain, Procedural (During Sternum Dressing on Infants) Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Physiological Parameters During Sternum Dressing in Babies Signs and Symptoms

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Küçükçekmece, Istanbul, 34303, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY

Behavioral

Using of baby mobile and listening Brahms Lullaby during sternum dressing process

Primary outcomes

  1. 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)).

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 20, 2021
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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