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Starting soon Not applicable

Animated Video and Booklet Education for Improving Asthma Control and Medication Compliance in Children

NCT06909318 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-05-15
Last updated
2025-04-08

Condition(s) studied

Asthma Bronchiale

Investigational drug(s) / intervention(s)

Asthma Education - Animated VideoBooklet Group

Asthma Education - Animated Video: This intervention consists of a 7-minute and 39-second animated video titled "Living with Asthma," specifically designed for children aged 7 to 11. The video features two characters, Mert and Robo, who explain asthma, its symptoms, triggers, and correct inhaler techniques in a child-friendly manner. The content is based on the latest GINA (2020) and NHLBI (2020) guidelines. The video is first watched in the clinic setting using a tablet device and then shared with parents via WhatsApp, email, or CD for home viewing. Parents are asked to watch the video with their child at least twice per week for two months and record viewing frequency using a structured observation form. This visual and engaging format distinguishes the intervention from conventional text-based education.

Booklet Group: This intervention involves the distribution of a 12-page, full-color, illustrated educational booklet titled "Living with Asthma," developed for children aged 7 to 11. The booklet covers topics such as asthma symptoms, triggers, medication use, and device techniques using simple language and visual aids. Its content was developed in line with GINA (2020) and National Heart, Lung, and Blood Institute (2020) recommendations. During the initial clinic visit, children and parents are introduced to the booklet and instructed to review it together at least twice per week over two months. Parents are also asked to log reading sessions using a structured observation form. This printed, interactive material offers a visually supported, age-appropriate alternative to standard asthma education methods.

Study summary

Asthma is a chronic inflammatory disease that causes wheezing, coughing, and shortness of breath, and it is a significant cause of morbidity and mortality in the pediatric population. The World Health Organization (WHO) estimated that 262 million people were affected by asthma in 2019, with 461,000 asthma-related deaths annually. In Turkey, the prevalence of asthma in children aged 6-12 ranges from 2% to 16%. Inadequate asthma control in children is often associated with poor medication adherence, lack of knowledge, misbeliefs, and ineffective communication with healthcare professionals. Education is therefore a crucial element of successful asthma management.

Recently, the use of digital tools such as animated videos has become increasingly popular in pediatric education due to their engaging and interactive nature. Studies have shown that visual and interactive materials can improve knowledge, satisfaction, and adherence in children with chronic illnesses.

This randomized controlled study aims to evaluate the effect of an educational intervention using an animated video and booklet on asthma control and medication compliance in children aged 7-11 diagnosed with asthma. It is expected that this child-friendly, visually enriched educational approach will enhance asthma management and support medication adherence in children.

Eligibility

Sex
ALL
Min age
7 Years
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria: * Children aged between 7 and 11 years * Diagnosed with asthma by a pediatric allergy specialist * Mild or moderate asthma severity according to GINA criteria * No communication difficulties * Have not received any asthma-related education outside of routine clinical care during the study period * No known mental or neurological disabilities * No serious chronic illness other than asthma (e.g., cardiac, neurological conditions) * At least one parent owns a smartphone or tablet * Child and parent volunteer to participate and provide informed consent Exclusion Criteria: * Children younger than 7 or older than 11 * Severe persistent asthma according to GINA criteria * Communication difficulties * Prior asthma education outside of routine clinical care * Children with cognitive or neurological impairments * Children who frequently require emergency care due to asthma exacerbations * Families without access to communication tools (e.g., no internet, smartphone, or unable to communicate) * Lack of consent from either the child or parent

Primary outcome measure(s)

  • Asthma control score (Childhood Asthma Control Test - C-ACT) — Baseline, 1st month, and 2nd month follow-up
    Asthma control will be assessed using the Childhood Asthma Control Test (C-ACT), a 7-item validated scale for children aged 4-11. Scores range from 0 to 27. A score ≥20 indicates controlled asthma; ≤19 indicates uncontrolled asthma. It will be administered at baseline, 1st month, and 2nd month follow-up.
  • Medication Adherence (MARS-5) — Baseline, 1st month, and 2nd month follow-up
    Medication adherence will be measured with the MARS-5 (Medication Adherence Report Scale), a 5-item Likert-type questionnaire. Scores range from 5 to 25; higher scores indicate better adherence. The scale will be administered at baseline, 1st month, and 2nd month.

Trial sites (1)

FacilityCityRegionStatus
Trakya University Faculty of Health Sciences Edirne Turkey
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06909318 on ClinicalTrials.gov ↗ ← All trials in Turkey