NCT06949202

Brief Summary

This study aims to evaluate the effect of diaphragmatic breathing exercises on stress and exam anxiety in final-year high school students during the exam period. The intervention, named "I Breathe, I Relieve," will include a series of controlled breathing exercises designed to reduce stress and anxiety symptoms. Participants will be asked to practice diaphragmatic breathing techniques daily for a specific period leading up to their exams. The study will measure changes in stress levels and anxiety through standardized scales and questionnaires, comparing results before and after the intervention. The study will contribute to understanding the impact of breathing exercises on mental health in young individuals facing academic pressures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

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
completed

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

April 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

April 22, 2025

Last Update Submit

June 19, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Exam Anxiety Level

    Change in scores on the Exam Anxiety Inventory from baseline to 4 weeks after intervention.

    Baseline and 4 weeks after intervention

  • Change in Perceived Stress Level

    Change in scores on the Perceived Stress Scale (14-item version) from baseline to 4 weeks after intervention.

    Baseline and 4 weeks after intervention

Secondary Outcomes (1)

  • Change in Oxygen Saturation

    During each training session (weekly, over 4 weeks)

Study Arms (2)

Breathing Exercises

EXPERIMENTAL

diaphragmatic breating breath control exercises

Other: breating exercises

Control Group

NO INTERVENTION

Participants in this group will not receive any training during the intervention period. They will only undergo evaluations at baseline and 4 weeks later. To ensure ethical standards, respiratory training will be offered to this group after the study is completed.

Interventions

diaphragmatic breathing

Breathing Exercises

Eligibility Criteria

Age16 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participant and their parent/legal guardian must provide informed consent.
  • Must be a final-year high school student preparing for the national university entrance exam.
  • Must be in good general health.No chronic illnesses that pose a risk for participation.
  • Aged between 16 and 19 years.

You may not qualify if:

  • Participant and/or their parent/legal guardian do not provide informed consent.
  • Failure to fully complete data collection tools (questionnaires, forms, etc.).
  • Inability to actively participate in the exercise sessions.
  • Presence of chronic health conditions that contraindicate participation in respiratory exercises.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iğdır Uni

Iğdır, State, 76000, Turkey (Türkiye)

Location

Related Publications (1)

  • Rosenberg A, Hamiel D. Reducing Test Anxiety and Related Symptoms Using a Biofeedback Respiratory Practice Device: A Randomized Control Trial. Appl Psychophysiol Biofeedback. 2021 Mar;46(1):69-82. doi: 10.1007/s10484-020-09494-9. Epub 2021 Jan 2.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • sema büğüşan oruç

    Iğdır Uni

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in the Department of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

April 22, 2025

First Posted

April 29, 2025

Study Start

May 1, 2025

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations