Clinical trial NCT06823869: The Effect of Distraction Methods on Children Aged 3-6 Years Receiving Inhaler Therapy
Official title: The Effect of Distraction Methods on Children Aged 3-6 Years Receiving Inhaler Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiration Disorders
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: this is a randoized controlled trial with a parallel assisnent design. participants will be randoly assgnrf to one of three groups: musical piano group, musical book group and control group (standard inhaler medication group). During the inhaler drug intake process, the child's fear and anxiety level will be compared between the three groups using distraction techniques.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: child fear scale
timeFrame: 5 minutes before the intervention, during the process and just after the intervention was completed. 20 minutes in total.
measure: Emotional Indicators Scale in Children
timeFrame: 5 minutes before the intervention, during the process and just after the intervention was completed. 20 minutes in total.
Secondary outcomes:
Other outcomes:
Locations:
city: Ayvacik
country: Turkey
facility: Samsun Ayvacık State Hospital
state: Samsun
Study officials:
affiliation: Ondokuz Mayıs University
name: Associate Professor Esra Tural Büyük
role: PRINCIPAL_INVESTIGATOR
References: