Inhalation Treatment Distraction in Children

NCT06874491 | Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/136
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fear Anxiety

Outcome Measures

Primary Outcomes (2)

• Child Fear Scale

  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

  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

Study Arms (3)

Moving and 3D Book Group

EXPERIMENTAL

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

Hand Puppet Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Moving and 3D Book BEHAVIORAL

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.

Moving and 3D Book Group

Hand Puppet BEHAVIORAL

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.

Hand Puppet Group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, Turkey (Türkiye)

RECRUITING

Central Study Contacts

ARZU SARIALIOGLU

CONTACT

04422315795; arzu.celebi@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)