Clinical trial NCT06909318: Animated Video and Booklet Education for Improving Asthma Control and Medication Compliance in Children
Official title: The Effect of Animated Video and Booklet Education on Asthma Control and Medication Compliance in Children With Asthma: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma Bronchiale
Keywords: pediatric
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 66
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed description: Asthma is a chronic inflammatory airway disease that affects millions of children worldwide and significantly impacts their quality of life, school attendance, and overall health. Despite the availability of effective treatments, asthma control remains suboptimal in many pediatric patients, often due to poor adherence, misinformation, and inadequate education. Educational interventions tailored to children's developmental levels are essential for improving disease management and medication compliance.

This study is designed as a randomized controlled trial to evaluate the impact of an educational program using both an animated video and an illustrated booklet developed specifically for children aged 7 to 11 with a diagnosis of asthma. The intervention focuses on key topics such as asthma triggers, correct inhaler use, symptom recognition, and medication adherence strategies.

Participants will be randomly assigned to either an intervention group receiving the animation and booklet-based education or a control group receiving standard care. Asthma control levels and medication adherence will be measured before and after the intervention using validated scales.

The findings of this study are expected to contribute to the development of child-friendly, visual educational tools that can be used by healthcare professionals in routine asthma care to enhance disease understanding, improve symptom control, and foster treatment adherence in pediatric populations.

Eligibility criteria: 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 outcomes:
measure: Asthma control score (Childhood Asthma Control Test - C-ACT)
timeFrame: Baseline, 1st month, and 2nd month follow-up
measure: Medication Adherence (MARS-5)
timeFrame: Baseline, 1st month, and 2nd month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University Faculty of Health Sciences
Study officials:
References: