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Clinical Trials/NCT06823869
NCT06823869Not yet recruitingNot Applicable

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

Ondokuz Mayıs University1 site in 1 country80 target enrollmentStarted: February 25, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
child fear scale

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

ın this study , both the participants and the investigators are aware of the intervention being applied. participants in the musical piano group, musical book group and control group are informed about the specific treatment they receive

Eligibility Criteria

Ages
3 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

musical book group

Active Comparator

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.

Intervention: musical book (Other)

musical piano group

Active Comparator

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.

Intervention: musical piano (Other)

group without toys

Sham Comparator

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.

Intervention: sham (Other)

Outcomes

Primary Outcomes

child fear scale

Time Frame: 5 minutes before the intervention, during the process and just after the intervention was completed. 20 minutes in total.

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

Emotional Indicators Scale in Children

Time Frame: 5 minutes before the intervention, during the process and just after the intervention was completed. 20 minutes in total.

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".

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ondokuz Mayıs University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Berna Sözen

Nurse

Ondokuz Mayıs University

Study Sites (1)

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