(Effect of Toy Nebulizer Versus Distraction Cards on Children's Fear and Parental Satisfaction Du… (NCT07417839) | Clinical Trial Compass
RecruitingNot Applicable
(Effect of Toy Nebulizer Versus Distraction Cards on Children's Fear and Parental Satisfaction During Nebulization Therapy: A Comparative Study
Iraq120 participantsStarted 2026-04-08
Plain-language summary
Goal To compare the effectiveness of a toy nebulizer versus distraction cards in reducing fear among children during nebulization therapy while improving parental satisfaction.
Aim To evaluate and measure children's fear levels and parents' satisfaction when using toy nebulizers compared to distraction cards in nebulization sessions.
Null hypothesis: (Hᴏ) There is no statistically significant difference in fear levels among children, and parental satisfaction scores in in the toy nebulizer, distraction cards, and control groups.
Alternative hypothesis: (H₁) There is a statistically significant difference in fear levels among children, and parental satisfaction scores in the toy nebulizer, distraction cards, and control groups.
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:Children aged 3-6 years receiving nebulization therapy for the first time due to acute respiratory conditions (e.g., asthma or bronchitis).
2\. Presence of at least one parent (preferably the mother) during the procedure who is capable of evaluation and communication in Arabic or Kurdish.
3\. Children who are alert and able to cooperate (absence of severe pain or any condition preventing basic communication).
4\. Voluntary written informed consent obtained from the parents and assent from the child (where applicable).
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Exclusion Criteria:Prior history of nebulization therapy (to ensure the fear response is not conditioned by past experiences).
2\. Children with cognitive, neurological, or developmental disabilities, or severe chronic illnesses (e.g., terminal cancer).
3\. Parental inability to complete fear or satisfaction questionnaires due to disability or illiteracy.
4\. Refusal to participate by the child or parent, or the presence of emergency conditions requiring immediate life-saving intervention.
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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.