NCT07722923

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

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 20, 2026

Last Update Submit

July 20, 2026

Conditions

Fibromyalgia

Outcome Measures

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.

    Baseline and Day 30

Secondary Outcomes (3)

  • Change in Pain Intensity Assessed by the Visual Analog Scale

    Baseline and Day 30

  • Change in Gastrointestinal Symptom Severity Assessed by the Gastrointestinal Symptom Rating Scale

    Baseline and Day 30

  • Change in Comfort Assessed by the General Comfort Scale

    Baseline and Day 30

Study Arms (2)

Box Breathing Exercise

EXPERIMENTAL

Participants in this arm will continue their routine treatment and 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.

Behavioral: Box Breathing Exercise

Routine Treatment

NO INTERVENTION

Participants in this arm will continue their routine treatment for 30 days and will not receive the box breathing exercise intervention. Outcome assessments will be completed at baseline and at the end of the 30-day study period.

Interventions

Box Breathing ExerciseBEHAVIORAL

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.

Box Breathing Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Emre ERKAL, PhD

CONTACT

+90 5433750709emreerkal@hotmail.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

September 15, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share