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

NCT06909318 | Not Yet Recruiting

• 1 other identifier: TUTF-SBF-ENK-06
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Bronchiale

Keywords

pediatric

Outcome Measures

Primary Outcomes (2)

• Asthma control score (Childhood Asthma Control Test - C-ACT)

  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.

  Baseline, 1st month, and 2nd month follow-up

• Medication Adherence (MARS-5)

  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.

  Baseline, 1st month, and 2nd month follow-up

Study Arms (3)

Arm 1 - Animation Video Group

EXPERIMENTAL

Children receive a 7-minute animated video titled "Living with Asthma" designed for ages 7-11, explaining asthma, its symptoms, triggers, and inhaler techniques through engaging characters. The video is watched initially during a clinic visit and then repeatedly at home with parental guidance over a two-month follow-up period. Parents record viewing frequency using the Parent Observation Form.

Behavioral: Asthma Education - Animated Video

Arm 2 - Booklet Group

ACTIVE COMPARATOR

Children receive a 12-page, illustrated asthma education booklet developed in accordance with GINA guidelines. The booklet is designed with child-friendly visuals and simple language. Parents are instructed to review the booklet with their children at least twice per week over two months and record reading activities using the Parent Observation Form.

Behavioral: Booklet Group

Arm 3- Control Group

NO INTERVENTION

Children receive routine care provided by the Pediatric Allergy and Immunology Outpatient Clinic. This includes standard written forms about allergen avoidance and treatment recommendations based on clinical assessments. No additional asthma education is given during the study period.

Interventions

Asthma Education - Animated Video BEHAVIORAL

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.

Arm 1 - Animation Video Group

Booklet Group BEHAVIORAL

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.

Arm 2 - Booklet Group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Faculty of Health Sciences

Edirne, Turkey, 22050, Turkey (Türkiye)

Location

Central Study Contacts

Dr. Esra Nur Kocaaslan Mutlu, PhD

CONTACT

5058888278; esranurkocaaslan27@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Dr. Esra Nur Kocaaslan Mutlu, Assistant Professor of Pediatric Nursing, Trakya University

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: May 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 15, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)