Clinical trial NCT06988254: Animation-Based Breathing Therapy for School-Age Children
Official title: Animation-Based Breathing Therapy for Children: A Novel Approach for School Settings
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Children
Breathing Patterns
Stress
School Health
Keywords: Children
Breathing
Stress
School
Well-being
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 130
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

-- 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.

Exclusion Criteria:

* 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,
* Diagnosed with psychotic disorder, bipolar disorder, or autism spectrum disorder,
* History of epilepsy or serious head trauma,
* Current use of psychotropic medications.

Primary outcomes:
measure: Chest Expansion Measurement
timeFrame: Baseline
Secondary outcomes:
measure: Chest Expansion Measurement
timeFrame: After six-week period
measure: Peak Expiratory Flow
timeFrame: Baseline
measure: Peak Expiratory Flow
timeFrame: After six-week period
measure: 10-Meter Walk Test
timeFrame: Baseline
measure: 10-Meter Walk Test
timeFrame: After six-week period
measure: Perceived Stress Scale in Children
timeFrame: Baseline
measure: Perceived Stress Scale in Children
timeFrame: After six-week period
measure: WHO-5 Child Wellbeing Index
timeFrame: Baseline
measure: WHO-5 Child Wellbeing Index
timeFrame: After six-week period
measure: Bourdon Attention Test
timeFrame: Baseline
measure: Bourdon Attention Test
timeFrame: After six-week period
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
state: Kartal
Study officials:
affiliation: Istanbul Medeniyet University
name: Tansu Birinci Olgun, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: