Asthma BronchialeNCT06909318
Animated Video and Booklet Education for Improving Asthma Control and Medication Compliance in Children
A study testing Asthma Education - Animated Video and Booklet Group in people with Asthma Bronchiale, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Asthma Bronchiale
- What is being tested?
- Asthma Education - Animated Video and Booklet Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Trakya University Faculty of Health Sciences
Edirne, Turkey, 22050
Esra Kocaaslan, 05058888278, esranurkocaaslan27@gmail.com
About this study
Official title: The Effect of Animated Video and Booklet Education on Asthma Control and Medication Compliance in Children With Asthma: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Asthma Bronchiale
- Being tested
- Asthma Education - Animated Video, Booklet Group
- Keywords
- pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma Education - Animated VideoBehavioural
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 GroupBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1st month, and 2nd month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start15 May 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma BronchialeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Nur Kocaaslan Mutlu, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909318
- Sponsor's protocol ID
- TUTF-SBF-ENK-06
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animated Video and Booklet Education on Asthma Control and Medication Compliance in Children With Asthma: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06909318
- Acronym / sponsor ID
- TUTF-SBF-ENK-06
- Conditions
- Asthma Bronchiale
- Keywords
- pediatric
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Animation Video Group | Experimental | Behavioral: Asthma Education - Animated VideoChildren 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. |
| Arm 2 - Booklet Group | Active comparator | Behavioral: Booklet GroupChildren 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. |
| 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma Education - Animated VideoThis 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. | Behavioural | Arm 1 - Animation Video Group |
| Booklet GroupThis 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. | Behavioural | Arm 2 - Booklet Group |
Primary outcome
Asthma control score (Childhood Asthma Control Test - C-ACT)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Education - Animated Video and Booklet Group in people with Asthma Bronchiale, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Esra Nur Kocaaslan Mutlu, PhD (5058888278, esranurkocaaslan27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control score (Childhood Asthma Control Test - C-ACT) (time frame: Baseline, 1st month, and 2nd month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.