FibromyalgiaNCT05840939
Pranayama and Diaphragmatic Breathing Exercise Applied to Female Patients With Fibromyalgia
A study testing Pranayama and diaphragm breathing exercise in people with Fibromyalgia, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Female patients diagnosed with fibromyalgia were divided into pranayama breathing exercise, diaphragm breathing exercise and control groups. The sleep quality, pain and fatigue levels of the patients in the intervention group were determined before and after the breathing exercise. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Pranayama and diaphragm breathing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2022to 30 Jun 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •● Being 18 years or older
- Being a female patient who has had pain for at least three months and has been diagnosed with fibromyalgia by a physician according to the ACR 2016 fibromyalgia diagnostic criteria.
- Having a PSQI score of five and above
- Complaint of fatigue and getting a score of 4 or above on the fatigue severity scale
- Pain score of one or above according to VAS
- Having no communication problems and knowing how to read, write and speak Turkish
- Not being pregnant and not breastfeeding
Who cannot join
- Having a malignancy related to the respiratory system (bronchus or lung)
- Having tuberculosis disease
- Having chest pain
- Having any psychiatric diagnosis during outpatient clinic screenings
- Having a nasal septum derivation or adenoid that will affect the ventilation process
- Having previously practiced/trained in pranayama or diaphragmatic breathing exercises
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pranayama and Diaphragmatic Breathing Exercise on Sleep Quality, Pain and Fatigue Level in Female Patients With Fibromyalgia
Female patients diagnosed with fibromyalgia were divided into pranayama breathing exercise, diaphragm breathing exercise and control groups. The sleep quality, pain and fatigue levels of the patients in the intervention group were determined before and after the breathing exercise.
Read the detailed description
Aim: This study was conducted to determine the effect of pranayama and diaphragm breathing exercises applied to female patients diagnosed with fibromyalgia on sleep quality, pain and fatigue levels.
Material and Method: This study, designed as a randomized controlled and experimental study, was conducted between November 2022 and June 2023. The data of the study consisted of 100 female patients diagnosed with fibromyalgia: 32 in the pranayama group, 33 in the diaphragm breathing exercise group and 35 in the control group. As data collection tools; Patient Information Form, Visual Analog Scale, Fatigue Severity Scale and Pittsburgh Sleep Quality Scale were used. During the study, the control group received routine treatment, while the two groups in the intervention group received the following training given by the researcher; They were asked to do pranayama and diaphragm breathing exercise 3 sets a day (morning-afternoon-evening), 7 days a week for 6 weeks. At the end of this process, sleep quality, pain and fatigue levels of three groups were evaluated again.
Results: It was observed that there was no statistically significant difference between the initial pain and sleep quality total scores of three groups (p>0.05), there was a significant difference between the groups in terms of pain, fatigue and sleep quality scores after the application (p<0.05).
Conclusion: As a result, it was determined that breathing exercises reduced the patients' pain and fatigue levels and improved their sleep quality.
Keywords: Pain, diaphragmatic breathing, fibromyalgia, pranayama, sleep quality, fatigue
- Conditions
- Fibromyalgia
- Being tested
- Pranayama, diaphragm breathing exercise
- Keywords
- Fibromyalgia, Pranayama, Diaphragmatic breathing, Quality of sleep, Pain, Fatigue
- Medical subject headings
- Fibromyalgia, Sleep Initiation and Maintenance Disorders, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PranayamaBehavioural
Pranayama, one of the practices of yoga, is a Sanskrit word consisting of a combination of two words, a technique of rhythmic, controlled breathing. So "prana" means life breath/life energy and "ayama" means expansion/regulation/control. Pranayama helps to improve lung capacity, heart and respiratory functions, nervous and hormonal systems, as well as mental activity.
diaphragm breathing exerciseBehavioural
Diaphragmatic breathing is also known as deep breathing or slow abdominal breathing. This breathing exercise uses the diaphragm muscle. The diaphragm is the muscle under the lungs that supports the lungs in up and down breathing.
| Study group | Role | What they receive |
|---|---|---|
| pranayama | Experimental | At the beginning, each patient in this group was shown one-on-one by the researcher and taught by applying them together, taking into account the application steps, how to practice pranayama. In the next step, the patients were asked to do this application themselves. Sleep quality, pain and fatigue levels of the patients were determined after 6 weeks. Receives: Behavioral: Pranayama |
| diaphragm breathing exercise group | Experimental | At the beginning, the patients in this group were shown how to do the diaphragm breathing exercise and how to do the diaphragm breathing exercise, taking into account the application steps, each patient was shown individually by the researcher and taught by applying them together. In the next step, the patients were asked to do this application themselves. Sleep quality, pain and fatigue levels of the patients were determined after 6 weeks. Receives: Behavioral: diaphragm breathing exercise |
| control group | No intervention | It is the group where no application has been made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
"0" indicates no pain and "10" indicates the most severe level of pain. On the scale, <3 mild pain, 3-6 moderate pain, >6 severe pain were specified.
Measured: [Time Frame: 6 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start11 Nov 2022
- Primary completion24 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted as a single-blind randomized controlled study with pretest-posttest.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Kilis 7 Aralik University
- Responsible party
- Principal investigator, Meltem Sungur, Inonu University
- Investigators
- MELTEM SUNGUR, Principal investigator, Kilis 7 Aralik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840939
- Sponsor's protocol ID
- 2344633
- Status last verified
- Jan 2024
- First submitted
- 6 Apr 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Can be reviewed by other researchers after the study has been published.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pranayama and Diaphragmatic Breathing Exercise on Sleep Quality, Pain and Fatigue Level in Female Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT05840939
- Acronym / sponsor ID
- 2344633
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pranayama, Diaphragmatic breathing, Quality of sleep, Pain, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- Kilis 7 Aralik University
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 May 2023 (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.
Female patients diagnosed with fibromyalgia were divided into pranayama breathing exercise, diaphragm breathing exercise and control groups. The sleep quality, pain and fatigue levels of the patients in the intervention group were determined before and after the breathing exercise.
Detailed description
Aim: This study was conducted to determine the effect of pranayama and diaphragm breathing exercises applied to female patients diagnosed with fibromyalgia on sleep quality, pain and fatigue levels.
Material and Method: This study, designed as a randomized controlled and experimental study, was conducted between November 2022 and June 2023. The data of the study consisted of 100 female patients diagnosed with fibromyalgia: 32 in the pranayama group, 33 in the diaphragm breathing exercise group and 35 in the control group. As data collection tools; Patient Information Form, Visual Analog Scale, Fatigue Severity Scale and Pittsburgh Sleep Quality Scale were used. During the study, the control group received routine treatment, while the two groups in the intervention group received the following training given by the researcher; They were asked to do pranayama and diaphragm breathing exercise 3 sets a day (morning-afternoon-evening), 7 days a week for 6 weeks. At the end of this process, sleep quality, pain and fatigue levels of three groups were evaluated again.
Results: It was observed that there was no statistically significant difference between the initial pain and sleep quality total scores of three groups (p>0.05), there was a significant difference between the groups in terms of pain, fatigue and sleep quality scores after the application (p<0.05).
Conclusion: As a result, it was determined that breathing exercises reduced the patients' pain and fatigue levels and improved their sleep quality.
Keywords: Pain, diaphragmatic breathing, fibromyalgia, pranayama, sleep quality, fatigue
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study was conducted as a single-blind randomized controlled study with pretest-posttest.
| Arm | Type | Receives |
|---|---|---|
| pranayama | Experimental | Behavioral: PranayamaAt the beginning, each patient in this group was shown one-on-one by the researcher and taught by applying them together, taking into account the application steps, how to practice pranayama. In the next step, the patients were asked to do this application themselves. Sleep quality, pain and fatigue levels of the patients were determined after 6 weeks. |
| diaphragm breathing exercise group | Experimental | Behavioral: diaphragm breathing exerciseAt the beginning, the patients in this group were shown how to do the diaphragm breathing exercise and how to do the diaphragm breathing exercise, taking into account the application steps, each patient was shown individually by the researcher and taught by applying them together. In the next step, the patients were asked to do this application themselves. Sleep quality, pain and fatigue levels of the patients were determined after 6 weeks. |
| control group | No intervention | –It is the group where no application has been made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- •● Being 18 years or older
- Being a female patient who has had pain for at least three months and has been diagnosed with fibromyalgia by a physician according to the ACR 2016 fibromyalgia diagnostic criteria.
- Having a PSQI score of five and above
- Complaint of fatigue and getting a score of 4 or above on the fatigue severity scale
- Pain score of one or above according to VAS
Key exclusion criteria (6 listed)
- Having a malignancy related to the respiratory system (bronchus or lung)
- Having tuberculosis disease
- Having chest pain
- Having any psychiatric diagnosis during outpatient clinic screenings
- Having a nasal septum derivation or adenoid that will affect the ventilation process
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 |
|---|---|---|
| PranayamaPranayama, one of the practices of yoga, is a Sanskrit word consisting of a combination of two words, a technique of rhythmic, controlled breathing. So "prana" means life breath/life energy and "ayama" means expansion/regulation/control. Pranayama helps to improve lung capacity, heart and respiratory functions, nervous and hormonal systems, as well as mental activity. | Behavioural | pranayama |
| diaphragm breathing exerciseDiaphragmatic breathing is also known as deep breathing or slow abdominal breathing. This breathing exercise uses the diaphragm muscle. The diaphragm is the muscle under the lungs that supports the lungs in up and down breathing. | Behavioural | diaphragm breathing exercise group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: [Time Frame: 6 weeks]
"0" indicates no pain and "10" indicates the most severe level of pain. On the scale, <3 mild pain, 3-6 moderate pain, >6 severe pain were specified.
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 24 Jan 2024.
- Individual participant dataSharing planned: Yes. Can be reviewed by other researchers after the study has been published.
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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.
MELTEM SUNGUR principal investigator
Kilis 7 Aralik University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pranayama and diaphragm breathing exercise in people with Fibromyalgia, run by Inonu University 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 7 inclusion and 6 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 24 Jan 2024. 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?
Visual Analog Scale (VAS) (time frame: [Time Frame: 6 weeks]). 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 24 Jan 2024.