Not Yet RecruitingNot Applicable

Effect of Using a Dragon Design Nebulizer Mask on Treatment Duration, Compliance and Fear in Children

Turkey (Türkiye)140 participantsStarted 2024-10

Plain-language summary

Incorporating playful elements into medical devices has been shown to enhance the overall experience for pediatric patients. Children want a healthcare setting that is spacious, creative, imaginative, and contemporary. Additionally, a current retrospective study of 127,368 pediatric patients indicates that 71.26% of the visits involved children under five years old, and 23.64% of the cases were due to respiratory infections. This information highlights the prevalence of inhaler therapy in emergency departments, particularly among young children with respiratory issues. This study aims to evaluate the impact of using dragon/turtle-themed nebulizer masks on treatment application time, treatment adherence, and fear levels in children who present to emergency rooms. By addressing these environmental and procedural challenges, the study seeks to improve the overall experience and outcomes for pediatric patients undergoing inhaler therapy.

Who can participate

Age range

3 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged between 3-6 years, * Presenting to the emergency department with a respiratory problem (such as an upper respiratory tract infection) requiring nebulizer treatment, * In general good health and suitable for nebulizer treatment (i.e., not having conditions like severe allergies or chronic respiratory failure), * Possessing age-appropriate language and communication skills, * Not previously familiar with the dragon-themed masks, * Having parental consent. Exclusion Criteria: * Children with major medical or psychiatric comorbidities as reported by the physician, nurse, or parent, * Children with a chronic health condition requiring regular nebulizer use (such as asthma), * Children with a fever of 38°C (100.4°F) or higher, * Children who have started treatment with sedative or anticonvulsant medications, * Children and parents with visual, auditory, verbal, or cognitive impairments that would interfere with the use of the intervention equipment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fear - Child Fear Scale

Timeframe: Immediately before (baseline) treatment (approximately 5 minutes before), each child's fear level will be assessed by the child and the nurse. Similarly, fear levels will be measured again during the intervention.

Trial details

NCT IDNCT06568120

SponsorKoç University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10

Contact for this trial

Eyşan Hanzade Savaş, PhD

5068418841 eumac14@ku.edu.tr

View on ClinicalTrials.gov More Fear trials