Active — Not RecruitingNot Applicable

The Effect of Using Nebula Bear on Anxiety and Fear During Nebulizer Application in Children

Turkey (Türkiye)40 participantsStarted 2024-12-28

Plain-language summary

Many respiratory system diseases are treated with inhalers. Providing inhaler treatment is provided by nebulizer devices. Taking the exact and effective dose of inhaler treatment affects the patient's recovery process. The use of nebulizer devices in children differs from that in adults. For children, the nebulizer may seem foreign and scary, which may cause them to reject inhaler treatment. Therefore, it is important to reduce anxiety and fear in children during nebulizer treatment. Since it is thought that the nebulizer bear, which is planned to be used in the study to reduce these negative situations caused by nebulizer treatment, may be effective in reducing anxiety and fear in children, it is thought that the study will have a positive physical and psychological contribution to children and parents.

Who can participate

Age range

4 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: Are between the ages of 4-6, Parent's ability to read and write Turkish, Accompanied by their parents, Children who are willing to participate in the research will be included in the research, They receive the first nebule treatment of their hospitalization. Exclusion Criteria: Have mental disabilities or communication problems, Visual or hearing impairment, Those who have any body function deficiency Children who routinely use nebulizers \-

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

Parent and Child Information Form

Timeframe: It will be filled out by the parent within the first 60 minutes of the child's hospitalization. (Approximately 5 minute.)

Child Fear Scale

Timeframe: It will be filled out by the researcher and parent 5 minutes before the procedure and 5 minutes after the procedure (Approximately 10 minute).

Children's Anxiety Meter-State (CAM-S)

Timeframe: It will be filled out by the child 5 minutes before the procedure and 5 minutes after the procedure (Approximately 5 minute).

Trial details

NCT IDNCT06769802

SponsorHavva Nur Özlenir

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-30

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