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Clinical Trials/NCT05881941
NCT05881941
Completed
Not Applicable

The Effect of Sound-Insulated Music Playing and Fıgured Mask Nebulızer Application on the Processing Anxiety of Children

Eda SORKUN1 site in 1 country120 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Eda SORKUN
Enrollment
120
Locations
1
Primary Endpoint
The Wong-Baker Faces Pain Scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this is a randomized controlled intervention study. The study was carried out to determine the effect of nebulization treatment applied to 3-6-year-old children with a soundproof, music player and figured mask nebulizer on the child's anxiety during the procedure. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine.

Detailed Description

This is a randomized controlled intervention study. The research was carried out in Kütahya Health Sciences University Evliya Çelebi Training and Research Hospital Paediatrics Emergency Service between 1st May 2022 and 1st June 2022. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine. In order to collect data, Descriptive Information Form, State Trait Anxiety Inventory for Parents, Child Fear Scale and Child Emotional Indicators Scale were used. The data obtained in the study were evaluated with the IBM SPSS Statistics 24 (Statistical Package for Social Sciences) package program.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
August 8, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Eda SORKUN
Responsible Party
Sponsor Investigator
Principal Investigator

Eda SORKUN

principal investigator

Eskisehir Osmangazi University

Eligibility Criteria

Inclusion Criteria

  • the child should be between the ages of 3-6,
  • will receive inhaler treatment,
  • the mother or father should be with the child during the procedure,
  • not have used any sedative drugs in the last 8 hours before the application,
  • written consent has been obtained from the parents after the procedure,
  • the child is not crying before the start

Exclusion Criteria

  • the child is younger than 3 years old, older than 6 years oldu,
  • the childe has a mental disability,
  • communication with the parent havinh a problem (they cannot understand and speak Turkish, etc.),
  • the child has pain,
  • the child is the terminal period,
  • the parent has a situation that prevents the assessment of the scale (mental disability, etc.)

Outcomes

Primary Outcomes

The Wong-Baker Faces Pain Scale

Time Frame: pre-processing

was developed by Donna Wong and Connie Morain Baker (1981) to be used to assess children's pain levels. It was revised in 1983 for assessing pain in children over the age of three (Wong-Baker Faces Foundation-http://wongbakerfaces.org/). In this scale, the pain score is determined according to the numerical values given to the various faces (Wong \& Baker, 1988; Wong-Baker Faces Foundation-http://wongbakerfaces.org/). In our study, the researcher filled in the Wong-Baker Faces Pain Scale before the procedure in order to identify the children who were experiencing pain so that they could be excluded from the study. Only children with a pain score of "0" were taken into the study.

The Child Fear Scale (CFS)

Time Frame: order of operation

was adapted by McMurty et al. (2011) from the Faces Anxiety Scale to measure anxiety in children undergoing painful medical procedures. The Child Fear Scale displays five faces with a range of expressions, from a neutral expression (0 = no anxiety) to a fearful face (4 = serious anxiety) (McMurtry et al., 2011). Permission is not required for the clinical and research usage of CFS. This scale was used in the study to determine the anxiety level of children before and during the procedure

The Children's Emotional Indicators Scale (CIAS)

Time Frame: order of operation

This scale is an easy-to-evaluate and easy-to-apply scale used to objectively define the emotional indicators of children during medical procedures.

Study Sites (1)

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