Effects of Conscious Connected Breathing Exercises on Fibromyalgia

NCT07030374 | Completed DMC

• 1 other identifier: 253/05.12.2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim in this study is to investigate the effects of conscious connected breathing exercises on sexual function, sleep, and mood in fibromyalgia patients. The investigators want to clearly show how breathing exercises affect sexual function, sleep, and mood in fibromyalgia patients by comparing the results from the control and study groups before and immediately after the sessions. By experiencing and learning breathing sessions, participants can do it on their own, wherever they want, without the need for a specific tool or examination, and change their lifestyle.

Conditions

Fibromyalgia Syndrome; Fibromyalgia Impact Questionnaire; Breathing Pattern Disorder; Female Sexual Dysfunction (FSD); Sleep; Anxiety State

Outcome Measures

Primary Outcomes (4)

• Fibromyalgia Impact Questionnaire (FIQ)

  The assessments will be administered again to the same participants following three sessions. The results of the pre- and post-surveys will be compared. Statistical analyses were conducted to compare the scores before and immediately after the breathing exercises and evaluate the differences between the groups (study and controls). The control group consists of women diagnosed with fibromyalgia who did not participate in breathing sessions.FIQ is to assess the effects of fibromyalgia. The questionnaire comprises ten principal inquiries. The maximum attainable score is 100, signifying a more severe clinical condition as value rise.

  comparision of scales before and immediately breathing exercises among groups

• Hospital Anxiety and Depression Scale (HADS)

  The assessments will be administered again to the same participants following three sessions. The results of the pre- and post-surveys will be compared. Statistical analyses were conducted to compare the scores before and immediately after the breathing exercises and evaluate the differences between the groups (study and controls). The control group consists of women diagnosed with fibromyalgia who did not participate in breathing sessions. The HADS consists of two subscales that evaluate both anxiety and depression. The scale typically consists of 14 items, divided equally into seven questions for the anxiety subscale and seven for the depression subscale. Each question pertains to a distinct emotional condition and allows patients to assess the emotional states they have encountered during a specified timeframe (usually within the last week).

  comparision of scales before and immediately breathing exercises among groups

• Jenkins Sleep Rating Scale (JSS)

  The assessments will be administered again to the same participants following three sessions. The results of the pre- and post-surveys will be compared. Statistical analyses were conducted to compare the scores before and immediately after the breathing exercises and evaluate the differences between the groups (study and controls). The control group consists of women diagnosed with fibromyalgia who did not participate in breathing sessions. The Jenkins Sleep Rating Scale (JSS), a measurement instrument for evaluating sleep disturbances. The questionnaire assessed issues such as "difficulty falling asleep, waking up several times during the night, not being able to sleep without waking up during the night, feeling tired and exhausted after waking up during a normal sleep period."

  comparision of scales before and immediately breathing exercises among groups

• Female Sexual Function Index (FSFI)

  The assessments will be administered again to the same participants following three sessions. The results of the pre- and post-surveys will be compared. Statistical analyses were conducted to compare the scores before and immediately after the breathing exercises and evaluate the differences between the groups (study and controls). The control group consists of women diagnosed with fibromyalgia who did not participate in breathing sessions. FSFI higher score means better sexual function (maximum score 36).

  comparision of scales before and immediately breathing exercises among groups

Study Arms (2)

intervention (breathing session) group

ACTIVE COMPARATOR

conscious connected breathing exercises

Other: conscious connected breathing exercises

control group

NO INTERVENTION

no breathing exercises

Interventions

conscious connected breathing exercises OTHER

conscious connected mouth breathing session where the diaphragm is activated

intervention (breathing session) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: women with Fibromyalgia Syndrome
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female fibromyalgia patients who applied to the Adana City Training and Research Hospital for physical therapy and rehabilitation outpatient clinic
• Patients with stable period of the disease (fibromyalgia)

You may not qualify if:

• Individuals diagnosed with schizoaffective illness,
• Individuals utilizing antipsychotic medications,
• Pregnant participants,
• Participants who did not finish three sessions

Sponsors & Collaborators

• Adana City Training and Research Hospital: lead

Study Sites (1)

Adana City Hospital

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Professor Gulsum Uysal

Model Details: intervention group (participating breathing sessions) and control group (not participating breathing sessions)

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 22, 2025
• Study Start: December 9, 2024
• Primary Completion: April 14, 2025
• Study Completion: April 21, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

TU (1)