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

Primary Purpose

Anxiety, Child, Only

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
using a soundproof nebulizer with a music and a funny mask added
using a silent nebulizer with no extra attachments
using a routinely employed nebulizer
Sponsored by
Eda SORKUN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring mask, Child, Anxiety, Nebulizer, Atraumatic Care

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • Osmangazi University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

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

using a silent nebulizer with no extra attachments

using a routinely employed nebulizer

Arm Description

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

Control group: using a routinely employed nebulizer

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
December 13, 2022
Last Updated
May 30, 2023
Sponsor
Eda SORKUN
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1. Study Identification

Unique Protocol Identification Number
NCT05881941
Brief Title
The Effect of Sound-Insulated Music Playing and Fıgured Mask Nebulızer Application on the Processing Anxiety of Children
Official Title
The Effect of Sound-Insulated Music Playing and Fıgured Mask Nebulızer Application on the Processing Anxiety of Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eda SORKUN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Child, Only
Keywords
mask, Child, Anxiety, Nebulizer, Atraumatic Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
. 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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
using a soundproof nebulizer with a music and a funny mask added
Arm Type
Experimental
Arm Description
Experimental group 1: using a soundproof nebulizer with a music and a funny mask added
Arm Title
using a silent nebulizer with no extra attachments
Arm Type
Experimental
Arm Description
Experimental group 2: using a silent nebulizer with no extra attachments
Arm Title
using a routinely employed nebulizer
Arm Type
Experimental
Arm Description
Control group: using a routinely employed nebulizer
Intervention Type
Device
Intervention Name(s)
using a soundproof nebulizer with a music and a funny mask added
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
using a silent nebulizer with no extra attachments
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
using a routinely employed nebulizer
Intervention Description
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 Outcome Measure Information:
Title
The Wong-Baker Faces Pain Scale
Description
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.
Time Frame
pre-processing
Title
The Children's Emotional Indicators Scale (CIAS)
Description
This scale is an easy-to-evaluate and easy-to-apply scale used to objectively define the emotional indicators of children during medical procedures.
Time Frame
order of operation
Title
The Child Fear Scale (CFS)
Description
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
Time Frame
order of operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayfer Açıkgöz
Organizational Affiliation
aacikgoz@ogu.edu.tr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osmangazi University
City
Eskişehir
State/Province
Centre
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
starting 6 months after publication

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

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