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Not yet recruiting NCT07722923

Effects of Box Breathing Exercise in Patients With Fibromyalgia

No phase Interventional Fibromyalgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Box Breathing Exercise.
Who it may be relevant to
Registry conditions: Fibromyalgia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral Box 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.

Primary outcome measures

  • Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index [Time frame: Baseline and Day 30]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07722923 · ACU-FM-BB-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗