FibromyalgiaNCT07722923
Effects of Box Breathing Exercise in Patients With Fibromyalgia
A study testing Box Breathing Exercise in people with Fibromyalgia, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Box Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Sep 2026to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Having a diagnosis of fibromyalgia
- Having a Visual Analog Scale pain score of 5 or higher
- Having a Pittsburgh Sleep Quality Index score of 5 or higher
- Being able to communicate and complete the study assessments
- Voluntarily agreeing to participate and providing informed consent
Who cannot join
- Having a respiratory condition such as asthma or chronic obstructive pulmonary disease
- Having a communication problem that prevents participation in the study procedures or completion of the assessment tools
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hitit University Çorum Erol Olçok Training and Research Hospital
Çorum
Ayşe Gülşen DOĞAN, MD, 5433750709, emreerkal@hotmail.de
About this study
Official title: Effects of Box Breathing Exercise on Sleep Quality, Pain, Gastrointestinal Symptoms, and Comfort in Patients With Fibromyalgia
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
- Conditions
- Fibromyalgia
- Being tested
- Box Breathing Exercise
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Box Breathing ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Box Breathing Exercise | Experimental | 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. Receives: Behavioral: Box Breathing Exercise |
| Routine Treatment | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 30
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start14 Sep 2026
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMRE ERKAL, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722923
- Sponsor's protocol ID
- ACU-FM-BB-2026-01
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Box Breathing Exercise on Sleep Quality, Pain, Gastrointestinal Symptoms, and Comfort in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07722923
- Acronym / sponsor ID
- ACU-FM-BB-2026-01
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Box Breathing Exercise | Experimental | Behavioral: Box Breathing ExerciseParticipants 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. |
| Routine Treatment | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older
- Having a diagnosis of fibromyalgia
- Having a Visual Analog Scale pain score of 5 or higher
- Having a Pittsburgh Sleep Quality Index score of 5 or higher
- Being able to communicate and complete the study assessments
Key exclusion criteria (2 listed)
- Having a respiratory condition such as asthma or chronic obstructive pulmonary disease
- Having a communication problem that prevents participation in the study procedures or completion of the assessment tools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Box Breathing ExerciseParticipants 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. | Behavioural | Box Breathing Exercise |
Primary outcome
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index
Time frame: Baseline and Day 30
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.
3 secondary outcomes
Change in Pain Intensity Assessed by the Visual Analog Scale
Time frame: Baseline and Day 30
Change in Gastrointestinal Symptom Severity Assessed by the Gastrointestinal Symptom Rating Scale
Time frame: Baseline and Day 30
Change in Comfort Assessed by the General Comfort Scale
Time frame: Baseline and Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Box Breathing Exercise in people with Fibromyalgia, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emre ERKAL, PhD (+90 5433750709, emreerkal@hotmail.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (time frame: Baseline and Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.