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Completed

NCT Number: NCT07030374

Effects of Conscious Connected Breathing Exercises on Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Syndrome Anxiety Disorders Anxiety State Breathing Pattern Disorder Female Sexual Dysfunction (FSD) Fibromyalgia Fibromyalgia Impact Questionnaire Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Sleep

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Adana City Hospital

Adana, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conscious connected breathing exercises

Other

conscious connected mouth breathing session where the diaphragm is activated

Primary outcomes

  1. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: comparision of scales before and immediately breathing exercises among groups

    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.

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: comparision of scales before and immediately breathing exercises among groups

    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).

  3. Jenkins Sleep Rating Scale (JSS)

    Time frame: comparision of scales before and immediately breathing exercises among groups

    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."

  4. Female Sexual Function Index (FSFI)

    Time frame: comparision of scales before and immediately breathing exercises among groups

    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).

Sponsors and collaborators

Lead sponsor

Adana City Training and Research Hospital

Other

Registry information

Official study title

Effects of Conscious Connected Breathing Exercises on Sexual Function, Sleep and Mood in Women With Fibromyalgia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

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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