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

NCT05881941 | Completed

• 1 other identifier: EskisehirOU2643
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Child, Only

Keywords

mask; Child; Anxiety; Nebulizer; Atraumatic Care

Outcome Measures

Primary Outcomes (3)

• The Wong-Baker Faces Pain Scale

  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.

  pre-processing

• The Children's Emotional Indicators Scale (CIAS)

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

  order of operation

• The Child Fear Scale (CFS)

  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

  order of operation

Study Arms (3)

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

EXPERIMENTAL

Experimental group 1: using a soundproof nebulizer with a music and a funny mask added

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

using a silent nebulizer with no extra attachments

EXPERIMENTAL

Experimental group 2: using a silent nebulizer with no extra attachments

Device: using a silent nebulizer with no extra attachments

using a routinely employed nebulizer

EXPERIMENTAL

Control group: using a routinely employed nebulizer

Device: using a routinely employed nebulizer

Interventions

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 soundproof nebulizer with a music and a funny mask added

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 silent nebulizer with no extra attachments

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

using a routinely employed nebulizer

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Eda SORKUN: lead

Study Sites (1)

Osmangazi University

Eskişehir, Centre, Turkey (Türkiye)

Location

Related Publications (1)

• Sorkun E, Acikgoz A, Sahin S. The Effect of Using Soundproof Nebulizers With Music and a Funny Mask Added to Reduce Children's Anxiety in Medical Procedures: A Randomized Controlled Experimental Study. J Eval Clin Pract. 2025 Aug;31(5):e70244. doi: 10.1111/jep.70244.

  PMID: 40838433 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ayfer Açıkgöz

  aacikgoz@ogu.edu.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: . 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

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: May 31, 2023
• Study Start: May 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: August 8, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: starting 6 months after publication

Locations

TU (1)