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

NCT06823869 | Not Yet Recruiting

• 1 other identifier: OndkusMU-SBF-BS-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiration Disorders

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

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.

Other: musical book

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.

Other: musical piano

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.

Other: sham

Interventions

musical book OTHER

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.

musical book group

musical piano OTHER

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.

musical piano group

sham OTHER

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.

group without toys

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• children with a mental problem
• non-volunteers

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Samsun Ayvacık State Hospital

Ayvacık, Samsun, 55550, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiration Disorders

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Associate Professor Esra Tural Büyük

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Berna Sözen

CONTACT

+90(535)8780200; bernasozenn55@gmail.com

Associate Professor Esra Tural Büyük

CONTACT

+90(505)2795196; esratural55@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 12, 2025
• Study Start: February 25, 2025
• Primary Completion: June 15, 2025
• Study Completion: July 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)