- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06949202
Diaphragmatic Breathing Exercises on Stress and Exam Anxiety in High School Seniors: A Randomized Study
The Effect of Diaphragmatic Breathing Exercises on Stress and Exam Anxiety in Final-Year High School Students During the Exam Period: "I Breathe, I Relieve"
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will be conducted in the city of Iğdır, Türkiye, and will involve final-year high school students currently enrolled in educational institutions in the region. Necessary permissions will be obtained from the Iğdır Provincial Directorate of National Education prior to the study.
The project is supported by TÜBİTAK 2209-A - University Students Research Projects Support Program.
Parental meetings will be organized, during which detailed information about the study will be provided to the families. The study will begin six weeks prior to the national university entrance examination.
After obtaining informed consent from both students and their families, demographic data including age, height, weight, and socio-cultural background will be recorded.
Oxygen saturation levels will be measured using a pulse oximeter.
To assess exam anxiety levels, the Tex Anxiety Inventory (TAI) will be used. This scale, developed by Spielberger and adapted into Turkish, consists of 20 items and two subscales: Worry (8 items) and Emotionality (12 items). Each item is rated on a 4-point Likert scale ranging from "almost never" to "always". The inventory evaluates the level of anxiety and its components experienced by individuals (References 8, 9).
To measure perceived stress levels, the Perceived Stress Scale (PSS) will be administered. The PSS assesses the degree to which individuals perceive situations in their lives as stressful. It consists of 14 items scored on a 5-point Likert scale ranging from 0 (never) to 4 (very often), with total scores ranging from 0 to 56. Higher scores indicate higher perceived stress levels (Reference 10).
Following initial evaluations, participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive training in diaphragmatic breathing, relaxation techniques, and respiratory exercises, including respiratory muscle training using a spirometer (References 4, 11).
These training sessions will be conducted once a week for 4 consecutive weeks, with each session lasting approximately 20 minutes. Oxygen saturation will be measured with a pulse oximeter before and after each session.
At the end of the 4-week intervention period, both the Test Anxiety Inventory and Perceived Stress Scale will be re-administered to assess changes in stress and anxiety levels. Statistical analyses will be conducted accordingly.
This is a randomized controlled trial (RCT). Students in the control group will undergo assessments but will not receive any training during the study period. However, to prevent ethical concerns, the same respiratory training will be offered to the control group participants after the completion of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
State
-
Iğdır, State, Turkey, 76000
- Iğdır Uni
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Breathing Exercises
diaphragmatic breating breath control exercises
|
diaphragmatic breathing
|
|
No Intervention: Control Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Exam Anxiety Level
Time Frame: Baseline and 4 weeks after intervention
|
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
Time Frame: Baseline and 4 weeks after intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Oxygen Saturation
Time Frame: During each training session (weekly, over 4 weeks)
|
Measured before and after each respiratory training session using pulse oximeter.
|
During each training session (weekly, over 4 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: sema büğüşan oruç, Iğdır Uni
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I1.25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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