Effects of Box Breathing Exercise 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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Box Breathing Exercise

Behavioral

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.

Primary outcomes

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.

Secondary outcomes

Change in Pain Intensity Assessed by the Visual Analog Scale

Time frame: 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

Time frame: Baseline and Day 30

Gastrointestinal symptoms will be assessed using the 15-item Gastrointestinal Symptom Rating Scale (GSRS). Items are rated on a 7-point scale, with higher scores indicating greater symptom severity. The change in the overall GSRS score from baseline to the end of the intervention will be evaluated.
Change in Comfort Assessed by the General Comfort Scale

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emre ERKAL, PhD

CONTACT

[email protected]

+90 5433750709

Sponsors and collaborators

Lead sponsor

Artvin Coruh University

Other

Registry information

Official study title

Effects of Box Breathing Exercise on Sleep Quality, Pain, Gastrointestinal Symptoms, and Comfort in Patients With Fibromyalgia

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 23, 2026
Registry last updated: Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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