Inhalation Treatment Distraction in Children

October 2, 2025 updated by: ARZU SARIALİOĞLU, Ataturk University

Effects of Two Different Distraction Methods on Fear and Anxiety Levels in Preschool Children Receiving Inhalation Treatment

The aim of the project is to examine the effects of two different distraction methods used in preschool children receiving inhalation therapy on fear and anxiety levels. Children are exposed to various hospital procedures throughout their lives. These procedures cause children to experience fear, pain and anxiety. One of these procedures is inhalation therapy. When children wear the face masks required for inhalation, they experience intense fear and anxiety. Non-pharmacological techniques are used for the effective management of this fear and anxiety. Among these techniques, distraction is the easy-to-apply. When applying distraction techniques, the child's developmental period, age group and interest should be taken into consideration. The project is a randomized controlled trial. The universe of the study will consist of children between the ages of 4-6 who received inhalation therapy for the first time in the pediatric emergency department of Erzincan Mengücek Gazi Education and Research Hospital between September 2025 and September 2026. In collecting the research data, "Questionnaire Form", "Child Fear Scale" and "Child Anxiety Scale-State" will be used.

The two different methods to be used will be designed to attract the attention and interest of the age groups of the children to be included in the research. In this way, it is thought that the child will focus his/her attention and curiosity on the two different methods to be used and the level of fear and anxiety will be affected during the inhalation treatment. This will increase the child's compliance and cooperation with the treatment and will encourage the child.

When the international and national literature was scanned, no study was found that investigated the effects of the two different distraction methods covered in the research during inhalation treatment. With the two different distraction methods to be used, inhalation treatment, which is a source of fear and anxiety for children, will become fun.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Children are exposed to various hospital procedures throughout their lives. These procedures cause children to experience fear, pain and anxiety. One of these procedures is inhalation therapy. When children wear the face masks required for inhalation, they experience intense fear and anxiety. Non-pharmacological techniques are used for the effective management of this fear and anxiety. Among these techniques, distraction is the easy-to-apply. When applying distraction techniques, the child's developmental period, age group and interest should be taken into consideration. The project is a randomized controlled trial. The universe of the study will consist of children between the ages of 4-6 who received inhalation therapy for the first time in the pediatric emergency department of Erzincan Mengücek Gazi Education and Research Hospital between September 2025 and September 2026. In collecting the research data, "Questionnaire Form", "Child Fear Scale" and "Child Anxiety Scale-State" will be used.

Movable and 3D book: Movable and 3D book that will be suitable and specially designed for inhalation therapy will be used. The book will include materials that children frequently encounter in inhalation therapy (mask, nebulizer, drug models used for treatment, a model of the nurse administering the treatment, and a model of the environment where inhalation therapy is performed). The book is aimed to attract children's attention by being made in an animated and three-dimensional form. The prepared book is presented to the opinions of experts in the field of child health and improvements will be made in line with the feedback. The final version of the book, which is specially designed and suitable for inhalation therapy, will be converted into two different formats and made ready for use in research. The aim of preparing it in two formats is to increase the child's interest in the book by giving him the right to choose. It is thought that this innovative book will have significant effects on children's fear and anxiety levels.

Hand Puppet: A hand puppet that is specially designed for inhalation therapy will be used. Hand puppets that aim to make inhalation therapy fun will be prepared (by playing with children the situations of different characters receiving inhalation therapy in the form of a game). The hand puppets that will be designed with the researcher, preschool teacher and child development specialist who receive play therapy will be prepared in a hypoallergenic form. In order to provide children with the right to choose, different forms will be prepared and children's ideas will be given importance. It is thought that the hand puppet that is specially designed for inhalation therapy will have significant effects on children's fear and anxiety levels.

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • -Being between 4-6 years old
  • Not having a developmental disability
  • Not having a history of sedative, analgesic or narcotic substance use within 24 hours before application
  • Receiving inhalation therapy for the first time
  • Not having a chronic disease
  • Children who are accompanied by their mother or father during the procedure will be included in the study.

Exclusion Criteria:

  • Being under 4 years old or over 6 years old
  • having a chronic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The data collector will be taken to the environment where the child will receive inhalation treatment and the routine procedures will be continued. Then, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes.
Experimental: Moving and 3D Book Group
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled. During the inhaler treatment, the researcher will ensure that the child spends time with a moving and 3D book that will be specially designed and suitable for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes.
Behavioral: Moving and 3D Book
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled out. During the inhaler treatment, the child will spend time with a moving and 3D book that will be specially designed for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled out again. Filling out the forms will take an average of 5-10 minutes.
Experimental: Hand Puppet Group
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and parent will be introduced and the purpose of the study will be explained and the scales will be filled. During the inhaler treatment, the researcher will ensure that the child spends time with a hand puppet that will be specially designed and suitable for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes.
Behavioral: Hand Puppet
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled out. During the inhaler treatment, the child will spend time with a hand puppet that will be specially designed for inhalation treatment by the researcher. After the treatment is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Fear Scale
Time Frame: 1 YEAR
The Child Fear Scale was developed by McMurty and colleagues in 2011 to measure fear in children undergoing painful medical procedures. The Turkish validity and reliability of the scale was performed by Özalp Gerçeker and colleagues in 2018. The Child Fear Scale is a 0-4 scale showing five faces ranging from a neutral expression (0 = no anxiety at all) to the feared face (4 = severe anxiety).
1 YEAR
Child Anxiety Scale-State
Time Frame: 1 YEAR
The scale, developed by Ersig and his colleagues in 2013, was validated in Turkish by Özalp Gerçeker and his colleagues in 2018. The "Children's Anxiety Scale-State, which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4 to 10. When the scale is introduced to the child, it is said that there is no anxiety, that anxiety increases as it goes up, and that the anxiety level is very high at the top. The child is then asked to draw a line in the section that shows how anxious or nervous he is.
1 YEAR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 25, 2026

Study Registration Dates

First Submitted

March 8, 2025

First Submitted That Met QC Criteria

March 8, 2025

First Posted (Actual)

March 13, 2025

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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