Effects of Conscious Connected Breathing Exercises on Fibromyalgia

NCT ID: NCT07030374

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-09
• Study Completion Date: 2025-04-21

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.

Detailed Description

Natural CCB sessions were conducted 3 times monthly (every Monday) for approximately 1.5 hours from 16:30 to 18:00 pm by qualified breathing coach (GU). Volunteer participants were recruited randomly. Initially, they were apprised of the study's objectives and methodologies. Secondly, a researcher (GYO) gathered sociodemographic data to ascertain admission criteria. Demographic information, including the duration of follow-up since the diagnosis of FMS, chronic disease history, medications utilized, age, body mass index, and marital status, will be solicited and documented. Participants completed the Fibromyalgia Impact Questionnaire (FIQ), Hospital Anxiety and Depression Scale (HADS), and Jenkins Sleep Rating Scale (JSS) and 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 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

intervention (breathing session) group

conscious connected breathing exercises

Group Type: ACTIVE_COMPARATOR

conscious connected breathing exercises

Intervention Type: OTHER

conscious connected mouth breathing session where the diaphragm is activated

control group

no breathing exercises

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

conscious connected breathing exercises

conscious connected mouth breathing session where the diaphragm is activated

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Adana City Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gulsum Uysal

Ass. Professor Gulsum Uysal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Adana City Hospital

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

253/05.12.2024

Identifier Type: -

Identifier Source: org_study_id