The Effect of Distraction Methods on Children Aged 3-6 Years Receiving Inhaler Therapy

The aim of this study is to observe the effect of distraction methods on children aged 3-6 years who apply to the emergency department due to respiratory complaints and receive inhaler medication.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiration Disorders
• Intervention / Treatment: Other: musical book; Other: musical piano; Other: sham

Detailed Description

The research was designed based on voluntary participation in threegroups: the experimental group (doll and musical keyboard or musical book) and the control group. The inhaler drug application process is planned to be 10 minutes.

First, routine explanations are given to the children in the experimental group, and the child is ensured to be in an upright position for the parent to be present and to administer the inhaler medication. The child is explained that a doll will accompany him during the inhaler medication administration, and a nebulization mask is attached to the doll. Before starting the inhaler medication administration, the doll is placed next to the child in a sitting position. The child is asked to sit with the doll for 5 minutes and the child is asked whether he/she will play with a musical book or a musical piano.After the child decides which toy he/she will play with and plays with the toy for 5 minutes, the Child Fear Scale (CCS) and the Children's Emotional Indicators Scale (ÇEGÖ) are evaluated by the child, parent, researcher, nurse and vital signs before starting the procedure. Later, when the researcher decides that the child is ready for the procedure, inhaler medication administration is started. After the drug administration is completed, the child, parent, researcher and nurse evaluate the CQS and CEGRS, and vital signs are evaluated by the researcher, and the parent gives a parental satisfaction score.

In the control group, a routine explanation of the emergency department is given to the child and the parent, the parent is next to the child and the child is ensured to sit upright during the inhaler medication administration. To the children in the control group, the researcher shows how the procedure will be done with a nebula mask on himself. The procedure begins after the necessary explanations are made and the researcher decides that the child is ready for inhaler medication administration. Before starting the procedure, the child, parent, researcher, nurse and vital signs are evaluated by the researcher. After the inhaler intake is completed, ÇÖS and ÇEGÖ child, researcher, nurse, parent; Vital signs are evaluated by the researcher and parental satisfaction score is given by the parent.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Berna Sözen; Phone Number: +90(535)8780200; Email: bernasozenn55@gmail.com
• Study Contact Backup: Name: Associate Professor Esra Tural Büyük; Phone Number: +90(505)2795196; Email: esratural55@gmail.com

Study Locations

• Turkey
  • Samsun
    • Ayvacik, Samsun, Turkey, 55550
      • Samsun Ayvacık State Hospital
      • Contact: Berna Sözen; Phone Number: +90(535)8780200; Email: bernasozenn55@gmail.com
      • Contact: Associate Professor Esra Tural Büyük; Phone Number: +90(505)2795196; Email: esratural55@gmail.com
      • Contact: Associate Professor Esra Tural Büyük

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• people who volunteer
• Children between 3 and 6 years old
• children without mental problems Children presenting to the emergency department with respiratory illnesses

Exclusion Criteria:

• children with a mental problem
• non-volunteers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: musical book group; During the inhaler medication treatment, the child will be accompanied by a toy doll with a nebul mask attached to its mouth, and the child will be asked which toy he would like to play with during the procedure. Children who answer musical books will be in this group.	Other: musical book; The child will indicate that he wants to play with the musical book. The child will play with toys for 5 minutes before treatment. Once the child is ready, inhaler medication will begin and the treatment will last 10 minutes. The treatment is terminated at the end of the 10th minute. The child's playing time with the toy is approximately 15 minutes.
Active Comparator: musical piano group; During the inhaler medication treatment, the child will be accompanied by a toy doll with a nebul mask attached to its mouth, and the child will be asked which toy he or she would like to play with during the procedure. Children who answer musical piano will be included in this group.	Other: musical piano; The child will indicate that he wants to play with the musical piano. The child will play with toys for 5 minutes before treatment. Once the child is ready, inhaler medication will begin and the treatment will last 10 minutes. The treatment is terminated at the end of the 10th minute. The child's playing time with the toy is approximately 15 minutes.
Sham Comparator: group without toys; Children will not be given toys, and the researcher will show the child how to apply the inhaler medication on herself with a nebul mask before the treatment.	Other: sham; The child will not play with toys during treatment. Before the treatment, the researcher demonstrates the process on himself with a nebul mask. Treatment begins after the child is ready. The process will take 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
child fear scale	Child Fear Scale:It is used to measure the child's anxiety level. It ranges from neutral expression (0=no anxiety). A scale ranging from 0 to 4, consisting of five drawn facial expressions ranging from a scared face (4=severe anxiety). is the scale	5 minutes before the intervention, during the process and just after the intervention was completed. 20 minutes in total.
Emotional Indicators Scale in Children	It was developed by Ho Cheung, William Li and Violeta Lopez in 2005. In the scale, emotional indicators are evaluated according to 5 parameters. These parameters; facial expression, voice, activity, interaction and cooperation level. These five parameters are from 1 to 5. The lowest score in total is "5" and the highest score is "25".	5 minutes before the intervention, during the process and just after the intervention was completed. 20 minutes in total.

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Principal Investigator: Associate Professor Esra Tural Büyük, Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Estimated): February 25, 2025
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders
• Other Study ID Numbers: OndkusMU-SBF-BS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I do not want my data to be used

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