Making inhalation therapy less scary for preschool children using distraction
Effects of Two Different Distraction Methods on Fear and Anxiety Levels in Preschool Children Receiving Inhalation Treatment
This project will test whether a movable 3D book or a hand puppet helps 4–6-year-olds feel less afraid and anxious during their first inhalation therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | Ataturk University Academic / other |
| Locations | 1 site (Erzurum) |
| Trial ID | NCT06874491 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will compare a specially designed movable 3D book and a hand puppet as distraction methods for preschool children receiving inhalation therapy. Children aged 4–6 who receive inhalation therapy for the first time in the pediatric emergency department at Erzincan Mengücek Gazi Education and Research Hospital will be randomly assigned to one of the two intervention groups. The 3D book includes animated models of masks, nebulizers, medication vials, nurses, and the treatment environment to attract attention, while the puppet is used to provide interactive distraction during mask placement. Fear and anxiety will be measured using a questionnaire, the Child Fear Scale, and the Child Anxiety Scale-State before and after the intervention.
Who should consider this trial
Good fit: Children aged 4–6 who are receiving inhalation therapy for the first time, have no developmental disability or chronic disease, have not used sedatives/analgesics/narcotics in the prior 24 hours, and are accompanied by a parent.
Not a fit: Children outside the 4–6 age range, those with developmental disabilities or chronic diseases, those with recent sedative/analgesic/narcotic use, or those who have previously received inhalation therapy are unlikely to be eligible or to benefit from these specific distraction methods.
Why it matters
Potential benefit: If successful, these low-cost distraction tools could reduce fear and anxiety during inhalation therapy and make the procedure easier for children and caregivers.
How similar studies have performed: Similar non-pharmacological distraction methods (books, puppets, and other attention-focused techniques) have previously shown benefit in reducing procedural fear and anxiety in children, so this study builds on existing positive findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * -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. Exclusion Criteria: * Being under 4 years old or over 6 years old * having a chronic disease
Where this trial is running
Erzurum
- Ataturk University Nursing of Faculty — Erzurum, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Arzu Sarialioglu
- Email: arzu.celebi@atauni.edu.tr
- Phone: 04422315795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.