Active — Not RecruitingNot Applicable

The Effect of Distraction Methods Used During Inhalation Therapy on Children's Fear and Anxiety

Turkey (Türkiye)120 participantsStarted 2024-04-08

Plain-language summary

It was aimed to examine the effects of distraction methods used during inhalation therapy on children's fear and anxiety. Hypothesis: Hypothesis 0 (H0): There is no difference between the fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques and toy type nebulizer + toy mask during inhaler treatment and the children in the control group. Hypothesis 1 (H1): The fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques during inhaler treatment are lower than the children in the control group. Hypothesis 2 (H2): The fear and anxiety levels of children who were applied a toy type nebulizer + toy mask during inhaler treatment are lower than the children in the control group. Hypothesis 3 (H3): The fear and anxiety levels of children who were treated with a toy type nebulizer + toy mask during inhaler treatment were lower than those of children who were treated with a normal nebulizer + mask + distraction techniques.

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: * Parent and child volunteer to participate in the study, * The child is between 3-6 years old, * Presentation due to upper and lower respiratory tract infection, * Inhaler treatment will be applied with a nebulizer, * No request for any other intravenous, intramuscular or invasive treatment, * The child does not have any genetic, congenital, chronic or metabolic disease, Exclusion Criteria: * Parent and child are not willing to participate in the study, * The child is not between 3-6 years old, * Presentation for a reason other than upper and lower respiratory tract infection, * No inhaler treatment with a nebulizer, * Request for any other intravenous, intramuscular or invasive treatment, * The child has any genetic, congenital, chronic or metabolic disease

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

changing the anxiety

Timeframe: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'

changing the fear

Timeframe: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'

Trial details

NCT IDNCT06510166

SponsorOndokuz Mayıs University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-08

View on ClinicalTrials.gov More Child trials

Plain-language summary

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.

What they're measuring

changing the anxiety

Timeframe: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'

changing the fear

Timeframe: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'