ChildrenNCT06988254
Animation-Based Breathing Therapy for School-Age Children
A study testing Animation-based breathing therapy in people with Children and Breathing Patterns, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to investigate the efficacy of animation-based breathing therapy on the physical (cough strength, chest expansion, and walking speed) and psychological health (perceived stress level, well-being, and attention) of school-age children. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Breathing Patterns, Stress
- What is being tested?
- Animation-based breathing therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -- Children aged between 8 and 12 years,
- Attending school and formal education regularly,
- Volunteers whose parents and themselves agreed to participate after being informed about the purpose of the study and the procedures involved, and who provided written informed consent.
Who cannot join
- Children with any condition that may prevent them from completing self-reported questionnaires during the assessment (e.g., difficulty in understanding forms, physical disabilities, illiteracy),
- History of any upper or lower extremity injury within the past six months,
- History of any upper or lower extremity surgery within the past six months,
- Presence of any soft tissue disorder,
- Diagnosed with serious gastrointestinal, cardiovascular, pulmonary, or hematological disorders following examination by a specialist physician,
- Diagnosed spinal problems such as scoliosis, kyphosis, or kyphoscoliosis,
Show all 9Show fewer
- Diagnosed with psychotic disorder, bipolar disorder, or autism spectrum disorder,
- History of epilepsy or serious head trauma,
- Current use of psychotropic medications.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University
Istanbul, Kartal, 34862
About this study
Official title: Animation-Based Breathing Therapy for Children: A Novel Approach for School Settings
This randomized controlled trial aims to investigate the efficacy of animation-based breathing therapy on the physical (cough strength, chest expansion, and walking speed) and psychological health (perceived stress level, well-being, and attention) of school-age children.
Read the detailed description
One hundred thirty school-age children, aged between 8 and 12, will be randomly assigned to one of two groups: an animation-based breathing therapy group or a control group. The intervention group will receive animation-based breathing therapy for six weeks (two sessions per day, five days per week). Assessments will be conducted at baseline and at the end of the six-week period. Cough strength will be measured using a peak expiratory flow meter. Chest expansion will be assessed with a measuring tape at the axillary, epigastric, and subcostal levels. Walking speed will be evaluated using the 10-Meter Walk Test. Perceived stress will be assessed using the Perceived Stress Scale for Children, well-being will be measured using the WHO-5 Child Wellbeing Index, and attention will be assessed using the Bourdon Attention Test.
- Conditions
- Children, Breathing Patterns, Stress, School Health
- Being tested
- Animation-based breathing therapy
- Keywords
- Children, Breathing, Stress, School, Well-being
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animation-based breathing therapyOther
The animation-based breathing therapy includes breathing exercises for children, such as lion, crab, and rainbow breathing. The intervention will continue for six weeks (two sessions per day, five days per week).
| Study group | Role | What they receive |
|---|---|---|
| Animation-based breathing therapy | Experimental | The intervention includes the animation-based breathing therapy for six weeks (two sessions per day, five days per week). Receives: Other: Animation-based breathing therapy |
| Control | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest Expansion Measurement
Chest expansion will be assessed using a measuring tape. While the children are in a relaxed seated position, measurements will be taken from the axillary, epigastric, and subcostal regions. The difference between the chest circumference at maximal inspiration and maximal expiration will be calculated and recorded.
Measured: Baseline
Secondary outcomes (11)
Chest Expansion Measurement
Chest expansion will be assessed using a measuring tape. While the children are in a relaxed seated position, measurements will be taken from the axillary, epigastric, and subcostal regions. The difference between the chest circumference at maximal inspiration and maximal expiration will be calculated and recorded.
Measured: After six-week period
Peak Expiratory Flow
Peak expiratory flow will be measured using a peak expiratory flow meter. The children will be instructed to take a deep breath and then exhale as forcefully and as quickly as possible into the device while in a standing position. The highest value from three consecutive trials will be recorded for analysis.
Measured: Baseline
Peak Expiratory Flow
Peak expiratory flow will be measured using a peak expiratory flow meter. The children will be instructed to take a deep breath and then exhale as forcefully and as quickly as possible into the device while in a standing position. The highest value from three consecutive trials will be recorded for analysis.
Measured: After six-week period
10-Meter Walk Test
Walking speed will be assessed using the 10-Meter Walk Test (10MWT). The 10MWT is a performance-based measure used to evaluate walking ability or gait speed over a short distance, expressed in meters per second. A 14-meter walkway will be marked, with 2-meter acceleration and deceleration zones at each end and a central 10-meter section for timing. Children will be asked to walk at their comfortable walking speed. Timing will begin when the child crosses the 2-meter mark and will stop when they pass the 12-meter mark. The time taken to walk the middle 10 meters will be recorded. The average of three trials will be calculated for analysis.
Measured: Baseline
10-Meter Walk Test
Walking speed will be assessed using the 10-Meter Walk Test (10MWT). The 10MWT is a performance-based measure used to evaluate walking ability or gait speed over a short distance, expressed in meters per second. A 14-meter walkway will be marked, with 2-meter acceleration and deceleration zones at each end and a central 10-meter section for timing. Children will be asked to walk at their comfortable walking speed. Timing will begin when the child crosses the 2-meter mark and will stop when they pass the 12-meter mark. The time taken to walk the middle 10 meters will be recorded. The average of three trials will be calculated for analysis.
Measured: After six-week period
Perceived Stress Scale in Children
Perceived stress levels of the children will be assessed using the "Perceived Stress Scale in Children." The scale consists of 9 items, rated on a 4-point Likert scale ranging from 1 (never), 2 (sometimes), 3 (often), to 4 (always). Higher scores indicate higher levels of perceived stress, and there are no reverse-coded items in the scale. The total score ranges from a minimum of 9 to a maximum of 36.
Measured: Baseline
Perceived Stress Scale in Children
Perceived stress levels of the children will be assessed using the "Perceived Stress Scale in Children." The scale consists of 9 items, rated on a 4-point Likert scale ranging from 1 (never), 2 (sometimes), 3 (often), to 4 (always). Higher scores indicate higher levels of perceived stress, and there are no reverse-coded items in the scale. The total score ranges from a minimum of 9 to a maximum of 36.
Measured: After six-week period
WHO-5 Child Wellbeing Index
Children's well-being will be assessed using the WHO-5 Child Wellbeing Index developed by the World Health Organization. The index consists of five positively worded items that reflect the participant's feelings over the past two weeks. Each item is rated on a 6-point Likert scale ranging from 0 to 5, where 0 indicates the absence of positive feelings during the past two weeks, and 5 indicates the constant presence of such feelings. The raw score is calculated by summing the scores of the five items, resulting in a total score between 0 and 25. To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A score of 0% represents the worst possible well-being, whereas a score of 100% indicates the best possible well-being.
Measured: Baseline
WHO-5 Child Wellbeing Index
Children's well-being will be assessed using the WHO-5 Child Wellbeing Index developed by the World Health Organization. The index consists of five positively worded items that reflect the participant's feelings over the past two weeks. Each item is rated on a 6-point Likert scale ranging from 0 to 5, where 0 indicates the absence of positive feelings during the past two weeks, and 5 indicates the constant presence of such feelings. The raw score is calculated by summing the scores of the five items, resulting in a total score between 0 and 25. To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A score of 0% represents the worst possible well-being, whereas a score of 100% indicates the best possible well-being.
Measured: After six-week period
Bourdon Attention Test
Attention will be assessed using the Bourdon Attention Test. In this test, children are asked to identify and mark specific target letters within a sequence of randomly arranged letters. A total of 660 letters are presented on a single page, divided into three sections. Participants are given four minutes to complete the task. During this period, they are instructed to locate and mark the designated letters (e.g., a, b, d, g) as quickly and accurately as possible. Scoring is based on the number of correctly marked target letters. Each correct identification is awarded one point, and the total number of accurate responses constitutes the individual's attention score.
Measured: Baseline
Bourdon Attention Test
Attention will be assessed using the Bourdon Attention Test. In this test, children are asked to identify and mark specific target letters within a sequence of randomly arranged letters. A total of 660 letters are presented on a single page, divided into three sections. Participants are given four minutes to complete the task. During this period, they are instructed to locate and mark the designated letters (e.g., a, b, d, g) as quickly and accurately as possible. Scoring is based on the number of correctly marked target letters. Each correct identification is awarded one point, and the total number of accurate responses constitutes the individual's attention score.
Measured: After six-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start19 May 2025
- Primary completion27 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tansu Birinci, Istanbul University - Cerrahpasa
- Investigators
- Tansu Birinci Olgun, PT, PhD, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988254
- Sponsor's protocol ID
- 17052025
- Status last verified
- May 2026
- First submitted
- 17 May 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animation-Based Breathing Therapy for Children: A Novel Approach for School Settings
- ClinicalTrials.gov ID
- NCT06988254
- Acronym / sponsor ID
- 17052025
- Conditions
- Children, Breathing Patterns, Stress, School Health
- Keywords
- Children, Breathing, Stress, School, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 May 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.
This randomized controlled trial aims to investigate the efficacy of animation-based breathing therapy on the physical (cough strength, chest expansion, and walking speed) and psychological health (perceived stress level, well-being, and attention) of school-age children.
Detailed description
One hundred thirty school-age children, aged between 8 and 12, will be randomly assigned to one of two groups: an animation-based breathing therapy group or a control group. The intervention group will receive animation-based breathing therapy for six weeks (two sessions per day, five days per week). Assessments will be conducted at baseline and at the end of the six-week period. Cough strength will be measured using a peak expiratory flow meter. Chest expansion will be assessed with a measuring tape at the axillary, epigastric, and subcostal levels. Walking speed will be evaluated using the 10-Meter Walk Test. Perceived stress will be assessed using the Perceived Stress Scale for Children, well-being will be measured using the WHO-5 Child Wellbeing Index, and attention will be assessed using the Bourdon Attention Test.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animation-based breathing therapy | Experimental | Other: Animation-based breathing therapyThe intervention includes the animation-based breathing therapy for six weeks (two sessions per day, five days per week). |
| Control | No intervention | –No Intervention |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- -- Children aged between 8 and 12 years,
- Attending school and formal education regularly,
- Volunteers whose parents and themselves agreed to participate after being informed about the purpose of the study and the procedures involved, and who provided written informed consent.
Key exclusion criteria (9 listed)
- Children with any condition that may prevent them from completing self-reported questionnaires during the assessment (e.g., difficulty in understanding forms, physical disabilities, illiteracy),
- History of any upper or lower extremity injury within the past six months,
- History of any upper or lower extremity surgery within the past six months,
- Presence of any soft tissue disorder,
- Diagnosed with serious gastrointestinal, cardiovascular, pulmonary, or hematological disorders following examination by a specialist physician,
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 |
|---|---|---|
| Animation-based breathing therapyThe animation-based breathing therapy includes breathing exercises for children, such as lion, crab, and rainbow breathing. The intervention will continue for six weeks (two sessions per day, five days per week). | Other | Animation-based breathing therapy |
Primary outcome
Chest Expansion Measurement
Time frame: Baseline
Chest expansion will be assessed using a measuring tape. While the children are in a relaxed seated position, measurements will be taken from the axillary, epigastric, and subcostal regions. The difference between the chest circumference at maximal inspiration and maximal expiration will be calculated and recorded.
11 secondary outcomes
Chest Expansion Measurement
Time frame: After six-week period
Peak Expiratory Flow
Time frame: Baseline
Peak Expiratory Flow
Time frame: After six-week period
10-Meter Walk Test
Time frame: Baseline
10-Meter Walk Test
Time frame: After six-week period
Perceived Stress Scale in Children
Time frame: Baseline
Perceived Stress Scale in Children
Time frame: After six-week period
WHO-5 Child Wellbeing Index
Time frame: Baseline
WHO-5 Child Wellbeing Index
Time frame: After six-week period
Bourdon Attention Test
Time frame: Baseline
Bourdon Attention Test
Time frame: After six-week period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Tansu Birinci Olgun, PT, PhD principal investigator
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animation-based breathing therapy in people with Children and Breathing Patterns, run by Istanbul University - Cerrahpasa 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 15 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest Expansion Measurement (time frame: Baseline). 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 15 May 2026.