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Completed

NCT Number: NCT05881941

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Child, Only Mental Disorders

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osmangazi University

Eskişehir, Centre, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.)

Treatment and study plan

using a soundproof nebulizer with a music and a funny mask added

Device

There were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer

using a silent nebulizer with no extra attachments

Device

There were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer

using a routinely employed nebulizer

Device

There were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Eda SORKUN

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 31, 2023
Registry last updated
May 31, 2023

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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