CompletedNot Applicable

Preparation Methods on PFT Performance

Turkey (Türkiye)96 participantsStarted 2022-03-15

Plain-language summary

Background: Successful spirometry in children depends on adequate cooperation and correct performance of respiratory maneuvers. Although several preparation strategies have been proposed, evidence comparing their effects on both spirometry performance and procedure-related fear remains limited. This study compared the effects of routine verbal instruction, verbal instruction with demonstration, and animation-assisted preparation on pulmonary function test (PFT) performance and procedure-related fear in children undergoing spirometry. Methods: This three-arm randomized controlled trial was conducted in the Pediatric Pulmonary Function Test Unit of a tertiary children's allergy and immunology outpatient clinic. Ninety-six children aged 6-12 years referred for spirometry were allocated using stratified randomization to routine verbal instruction (control, n = 32), verbal instruction with demonstration (n = 32), or animation-assisted preparation (n = 32). Data were collected using Descriptive Characteristics Form, Pulmonary Function Test Parameters Form, and Children's Fear Scale (CFS). Pulmonary function parameters were recorded during the first three acceptable spirometry maneuvers, and procedure-related fear was assessed immediately before and after testing.

Who can participate

Age range

6 Years – 12 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 were eligible for inclusion if they were 6-12 years of age and had no cognitive, visual, or hearing impairments that could interfere with understanding or performing the spirometry procedure. Exclusion Criteria: * Children were excluded if they were unable to understand or communicate in Turkish, had communication difficulties, declined to participate, had conditions that could interfere with spirometry performance (e.g., cleft lip, cleft palate, jaw anomalies, or oral/dental problems preventing an adequate seal around the mouthpiece), or had previously viewed or used the Fish Animation employed in the animation-assisted preparation to avoid familiarity and learning effects. Withdrawn criteria: \- Participants were withdrawn from the study if they completed fewer than three acceptable spirometry maneuvers, discontinued the procedure before completion, or requested to withdraw during testing.

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

Descriptive Characteristics Form

Timeframe: First measurement-5. minutes before the start of the pulmonary function test

Children's Fear Scale

Timeframe: First measurement- 1 minutes before the start of the pulmonary function test

Trial details

NCT IDNCT07713225

SponsorSelcuk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-15

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