Fibromyalgia
Conditions
Brief 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. 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
Interventions
BEHAVIORALBox Breathing Exercise
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.
Sponsors
Artvin Coruh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Assessed by the Visual Analog Scale | Baseline and Day 30 | 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. |
| Change in Gastrointestinal Symptom Severity Assessed by the Gastrointestinal Symptom Rating Scale | Baseline and Day 30 | 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. |
| Change in Comfort Assessed by the General Comfort Scale | Baseline and Day 30 | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEmre ERKAL, PhD
Outcome results
None listed