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NCT Number: NCT07722923

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

Primary location

Hitit University Çorum Erol Olçok Training and Research Hospital

Çorum, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayşe Gülşen DOĞAN, MD

CONTACT

[email protected]

5433750709

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

  1. 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

  1. 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.

  2. 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). 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.

  3. 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
Sep 16, 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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