An interventional study of Box Breathing Exercise in Fibromyalgia, sponsored by Artvin Coruh University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Artvin Coruh University · Not applicable, Interventional, and Supportive care
Fibromyalgia is a chronic condition that can cause widespread pain, sleep problems, fatigue, gastrointestinal symptoms, and reduced comfort. This study will evaluate whether box breathing exercise improves sleep quality, pain, gastrointestinal symptoms, and comfort in patients with fibromyalgia.
A total of 60 participants will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will continue their routine treatment and perform box breathing exercises for 10 minutes twice daily for 30 days. Participants in the control group will continue their routine treatment without receiving the breathing exercise. Sleep quality, pain, gastrointestinal symptoms, and comfort will be assessed at the beginning and at the end of the 30-day study period
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Artvin Coruh University is the lead sponsor of 29 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will continue their routine treatment and perform box breathing exercises for 10 minutes twice daily, in the morning and evening, for 30 days. Each breathing cycle consists of inhaling through the nose for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding the breath again for 4 seconds.
Behavioral: Box Breathing Exercise
Participants in this arm will continue their routine treatment for 30 days and will not receive the box breathing exercise intervention. Outcome assessments will be completed at baseline and at the end of the 30-day study period.
Participants will perform box breathing exercises for 10 minutes twice daily, in the morning and evening, for 30 days. Each breathing cycle consists of inhaling through the nose for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding the breath again for 4 seconds.
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The change in total PSQI score from baseline to the end of the intervention will be evaluated.
Time frame: Baseline and Day 30
Change in Pain Intensity Assessed by the Visual Analog Scale
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. The change in VAS score from baseline to the end of the intervention will be evaluated.
Time frame: Baseline and Day 30
Change in Gastrointestinal Symptom Severity Assessed by the Gastrointestinal Symptom Rating Scale
Gastrointestinal symptoms will be assessed using the 15-item Gastrointestinal Symptom Rating Scale (GSRS). Each item is rated on a 7-point scale ranging from 1 to 7. The total GSRS score ranges from 15 to 105, with higher scores indicating greater gastrointestinal symptom severity. The change in the total GSRS score from baseline to the end of the intervention will be evaluated.
Time frame: Baseline and Day 30
Change in Comfort Assessed by the General Comfort Scale
Comfort will be assessed using the 48-item General Comfort Scale. After reverse-scoring the negatively worded items, the total score will be divided by the number of items to obtain a mean score ranging from 1 to 4. Higher scores indicate greater comfort. The change in the mean score from baseline to the end of the intervention will be evaluated.
Time frame: Baseline and Day 30
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.
Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 12 months is below that.
Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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Artvin Coruh University