NCT06988254

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

May 17, 2025

Last Update Submit

May 24, 2025

Conditions

Keywords

ChildrenBreathingStressSchoolWell-being

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (11)

  • Chest Expansion Measurement

    After six-week period

  • Peak Expiratory Flow

    Baseline

  • Peak Expiratory Flow

    After six-week period

  • 10-Meter Walk Test

    Baseline

  • 10-Meter Walk Test

    After six-week period

  • +6 more secondary outcomes

Study Arms (2)

Animation-based breathing therapy

EXPERIMENTAL

The intervention includes the animation-based breathing therapy for six weeks (two sessions per day, five days per week).

Other: Animation-based breathing therapy

Control

NO INTERVENTION

No Intervention

Interventions

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).

Animation-based breathing therapy

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \-- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kartal, 34862, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tansu Birinci Olgun, PT, PhD

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2025

First Posted

May 23, 2025

Study Start

May 20, 2025

Primary Completion

June 27, 2025

Study Completion

June 30, 2025

Last Updated

May 30, 2025

Record last verified: 2025-05

Locations