Fibromyalgia SyndromeNCT07030374
Effects of Conscious Connected Breathing Exercises on Fibromyalgia
A study testing conscious connected breathing exercises in people with Fibromyalgia Syndrome and Fibromyalgia Impact Questionnaire, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia Syndrome, Fibromyalgia Impact Questionnaire, Breathing Pattern Disorder
- What is being tested?
- conscious connected breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2024to 21 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Individuals diagnosed with schizoaffective illness,
- Individuals utilizing antipsychotic medications,
- Pregnant participants,
- Participants who did not finish three sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Conscious Connected Breathing Exercises on Sexual Function, Sleep and Mood in Women With 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.
Read the 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
- Being tested
- conscious connected breathing exercises
- Medical subject headings
- Fibromyalgia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conscious connected breathing exercisesOther
conscious connected mouth breathing session where the diaphragm is activated
| Study group | Role | What they receive |
|---|---|---|
| intervention (breathing session) group | Active comparator | conscious connected breathing exercises Receives: Other: conscious connected breathing exercises |
| control group | No intervention | no breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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."
Measured: 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).
Measured: comparision of scales before and immediately breathing exercises among groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start9 Dec 2024
- Primary completion14 Apr 2025
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- intervention group (participating breathing sessions) and control group (not participating breathing sessions)
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adana City Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsum Uysal, Adana City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030374
- Sponsor's protocol ID
- 253/05.12.2024
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: demographical values could be shared. The questionaries answers are personal so only scale results may be shown.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Conscious Connected Breathing Exercises on Sexual Function, Sleep and Mood in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07030374
- Acronym / sponsor ID
- 253/05.12.2024
- Conditions
- Fibromyalgia Syndrome, Fibromyalgia Impact Questionnaire, Breathing Pattern Disorder, Female Sexual Dysfunction (FSD), Sleep, Anxiety State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Adana City Training and Research HospitalUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention group (participating breathing sessions) and control group (not participating breathing sessions)
| Arm | Type | Receives |
|---|---|---|
| intervention (breathing session) group | Active comparator | Other: conscious connected breathing exercisesconscious connected breathing exercises |
| control group | No intervention | –no breathing exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- Individuals diagnosed with schizoaffective illness,
- Individuals utilizing antipsychotic medications,
- Pregnant participants,
- Participants who did not finish three sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conscious connected breathing exercisesconscious connected mouth breathing session where the diaphragm is activated | Other | intervention (breathing session) group |
Primary outcome
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.
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).
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."
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Undecided. demographical values could be shared. The questionaries answers are personal so only scale results may be shown.
Related trials for Fibromyalgia Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conscious connected breathing exercises in people with Fibromyalgia Syndrome and Fibromyalgia Impact Questionnaire, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (FIQ) (time frame: comparision of scales before and immediately breathing exercises among groups). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.