Effects of Box Breathing Exercise in Patients With Fibromyalgia
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArtvin Coruh University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Box Breathing Exercise
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Box Breathing ExerciseExperimental treatment 1 intervention
Group B: Routine TreatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 30Secondary outcomes
1
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 302
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 303
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 30Sponsors and contacts
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Source ClinicalTrials.gov