FibromyalgiaNCT06508385
The Effect of Perception of Improvement in Patients With Fibromyalgia
A study testing Breathing exercise in people with Fibromyalgia, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Fibromyalgia (FM) is a chronic pain syndrome characterized by impaired perception, transmission, and processing of nociceptive stimuli and causing widespread pain. Pain in FM is the disease itself and is characterized by nociplastic pain that may occur independently of any peripheral nociceptor activity or be felt… Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2024to 3 Aug 2026
- 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 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with Fibromyalgia at least 1 year ago according to ACR criteria
- Age range 25-55
- Female
- Scored at least 24 on the Mini-Mental State Assessment Test
- Reported weekly pain intensity of at least 40 mm on the Visual Analog Scale
- Be on a stable dose of medication for at least 6 months (serotonin norepinephrine reuptake inhibitors [e.g., duloxetine, milnacipran]; alpha 2-delta receptor ligand [e.g., pregabalin]; gabapentinoids)
Who cannot join
- Having inflammatory rheumatic disease, malignancy, neurological disease, connective tissue disease, severe anemia, uncontrolled endocrine diseases
- Body Mass Index (BMI) ≥ 30 Kg/m2
- Being pregnant
- Having inability to understand, read and speak Turkish
- Having difficulty in hearing and seeing
- Having any metallic or electronic device in the body that will create incompatibility with the magnetic field in the fMRI scan Having any disease diagnosis (serious psychotic disorder, delirium, mental retardation, epilepsy, heart disease, lung diseases, etc.) that may prevent participation in the evaluation and training to be conducted within the scope of the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perception of Improvement Provided Virtual Reality Environment on Symptom Presence and Severity in Patients With Fibromyalgia
Fibromyalgia (FM) is a chronic pain syndrome characterized by impaired perception, transmission, and processing of nociceptive stimuli and causing widespread pain. Pain in FM is the disease itself and is characterized by nociplastic pain that may occur independently of any peripheral nociceptor activity or be felt without disease or damage to the somatosensory system. It is thought that the pain processing process is disrupted due to the changing neurotransmitter release activity and this situation causes pain to be felt more in FM. Chronic pain is the result of perception alteration associated with nociceptive afferent information affecting the cortex; underlying this change are limbic emotional learning mechanisms. Numerous factors, including emotional state, attention, and past painful experiences, modulate nociceptive inputs with the activation of multiple brain regions, resulting in a personalized pain experience. The chronic pain management program should target the central nervous system rather than the peripheral tissues because pain originates in the sensitized nervous system. For this reason, it is important to include plasticity-oriented approaches, cortical disinhibition methods, and strategies for improving perception and behavior change, which aim to replace negative beliefs with positive beliefs, into clinical practice. Our project aims to investigate the effectiveness of the therapeutic intervention, which consists of patient education supported Neuro-Linguistic Programming (NLP), visual feedback and metaphor-assisted breathing therapy designed to provide a perception of improvement and presented in a virtual reality environment, on pain processing, pain intensity, pain-pressure threshold, psychosomatic reflections (biomechanical and viscoelastic properties of tissue, sleep quality, pain catastrophizing behavior, anxiety and depression), disease impact and quality of life in FM patients.
- Conditions
- Fibromyalgia
- Being tested
- Breathing exercise
- Keywords
- functional brain activity, Pain, Tissue properties
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseOther
Breathing exercises will include;
- Correct posture and sitting
- Nose opening techniques
- Diaphragmatic breathing, which consists of continuous and deep nasal inspiration with movement of the abdominal region and diaphragm
- Main Breathing exercise (during 5 minutes)=inspiration (during 5 seconds) + expiration (during 15 seconds).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | NLP-supported patient education will be given and breath therapy will be applied to the Control Group Receives: Other: Breathing exercise |
| Virtual Reality Group-1 | Experimental | NLP-supported patient education will be given. Visual feedback and metaphor-assisted breathing therapy over the three most painful points in the McGill-Melzack Pain Scale (real painful points) were given to this group in virtual reality environment. Receives: Other: Breathing exercise |
| Virtual Reality Group-2 | Experimental | NLP-supported patient education will be given. Visual feedback and metaphor-assisted breathing therapy over the contralateral of the points reported as the three most painful points in the McGill-Melzack Pain Scale (virtual painful points) to this group in a virtual reality environment Receives: Other: Breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Magnetic Resonance
The process of processing pain will be determined by functional magnetic resonance imaging performed immediately before and after the experimental pressure pain. ROI analysis will ve performed. No score is defined.
Measured: Measurement of changes from baseline process of processing pain will be measured at 6 week and 10 week
Measurement of pain-pressure threshold
Pain-pressure threshold evaluated with a pain threshold measuring device (Algometer).
Measured: Measurement of changes from baseline of pain-pressure threshold will be measured at 6 week and 10 week
Secondary outcomes (11)
Sleep Quality
Sleep quality will be evaluated with Pittsburgh Sleep Quality Index. Score is between 0 (the best sleep quality) and 21 (the worst sleep quality)
Measured: Measurement of changes from baseline of sleep quality will be measured at 6 week and 10 week
Functional status and disease impact
Functional status and disease impact will be evaluated with Revised Fibromyalgia Impact Questionnaire. Score is between 0 (no disease impact and 100 (the highest disease impact)
Measured: Measurement of changes from baseline of functional status and disease impact will be measured at 6 week and 10 week.
Quality of Life of patients
Quality of Life will be measured with QOL Short Form 12. Score is between 0 (the lowest quality of life and 100 (the highest quality of life)
Measured: Measurement of changes from baseline of quality of life will be measured at 6 week and 10 week
Anxiety and Depression Status
Anxiety and Depression will be evaluated with Hospital Anxiety and Depression Scale. Score is between 0 (no anxiety and depression risk) and 21 (the highest anxiety and depression risk)
Measured: Measurement of changes from baseline of anxiety and depression status will be measured at 6 week and 10 week
Pain catastrophizing behavior
Assessing pain catastrophizing behavior will be evaluated with Pain Catastrophizing Scale. Score is between 0 (no pain catastrophizing behavior) and 52 (the highest pain catastrophizing behavior)
Measured: Measurement of changes from baseline of changes from baseline of pain catastrophizing behaviors will be measured at 6 week and 10 week
Patient satisfaction
Patient satisfaction will be evaluated with Global Rating of Change. No score is defined.
Measured: Measurement of changes from baseline of patient satisfaction will be measured at 6 week and 10 week
Measurement of biomechanical characteristics of tissue
Stiffness values of tissue will be measured with myotonPro B1 over the three most painful points in Control Group and Virtual Reality-1 Group.
Stiffness values of tissue will be measured with myotonPro B1 over the contralateral of the points reported as the three most painful points in Virtual Reality-2 Group.
Measured: Measurement of changes from baseline stiffness values of tissue will be measured at 6 week and 10 week]
Measurement of biomechanical characteristics of tissue
Tone values of tissue will be measured with myotonPro B1 over the three most painful points in Control Group and Virtual Reality-1 Group.
Tone values of tissue will be measured with myotonPro B1 over the contralateral of the points reported as the three most painful points in Virtual Reality-2 Group.
Measured: Measurement of changes from baseline tone values of tissue will be measured at 6 week and 10 week]
Measurement of biomechanical characteristics of tissue
Decrement values of tissue will be measured with myotonPro B1 over the three most painful points in Control Group and Virtual Reality-1 Group.
Decrement values of tissue will be measured with myotonPro B1 over the contralateral of the points reported as the three most painful points in Virtual Reality-2 Group.
Measured: Measurement of changes from baseline decrement values of tissue will be measured at 6 week and 10 week]
Measurement of viscoelastic characteristics of tissue
Creep values of tissue will be measured with myotonPro B1 over the three most painful points in Control Group and Virtual Reality-1 Group.
Creep values of tissue will be measured with myotonPro B1 over the contralateral of the points reported as the three most painful points in Virtual Reality-2 Group.
Measured: Measurement of changes from baseline creep values of tissue will be measured at 6 week and 10 week]
Measurement of viscoelastic characteristics of tissue
Relaxation time values of tissue will be measured with myotonPro B1 over the three most painful points in Control Group and Virtual Reality-1 Group.
Relaxation time values of tissue will be measured with myotonPro B1 over the contralateral of the points reported as the three most painful points in Virtual Reality-2 Group.
Measured: Measurement of changes from baseline relaxation time values of tissue will be measured at 6 week and 10 week]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start13 Aug 2024
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilufer Kablan, Istanbul Medeniyet University
- Investigators
- Nilüfer Kablan, PhD, Principal investigator, İstanbul Medeniyet Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508385
- Sponsor's protocol ID
- 2023/0689
- Status last verified
- Oct 2026
- First submitted
- 12 Jul 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adams LM, Turk DC. Psychosocial factors and central sensitivity syndromes. Curr Rheumatol Rev. 2015;11(2):96-108. doi: 10.2174/1573397111666150619095330.
PubMed 26088211Arnold LM, Bennett RM, Crofford LJ, Dean LE, Clauw DJ, Goldenberg DL, Fitzcharles MA, Paiva ES, Staud R, Sarzi-Puttini P, Buskila D, Macfarlane GJ. AAPT Diagnostic Criteria for Fibromyalgia. J Pain. 2019 Jun;20(6):611-628. doi: 10.1016/j.jpain.2018.10.008. Epub 2018 Nov 16.
PubMed 30453109Caneiro JP, Bunzli S, O'Sullivan P. Beliefs about the body and pain: the critical role in musculoskeletal pain management. Braz J Phys Ther. 2021 Jan-Feb;25(1):17-29. doi: 10.1016/j.bjpt.2020.06.003. Epub 2020 Jun 20.
PubMed 32616375Ciaramella A. Hypnotic analgesia in chronic pain: role of psychopathology and alexithymia. Am J Clin Hypn. 2023 Apr;65(4):299-313. doi: 10.1080/00029157.2022.2161868. Epub 2023 Feb 7.
PubMed 36749869de la Coba P, Montoro CI, Reyes Del Paso GA, Galvez-Sanchez CM. Algometry for the assessment of central sensitisation to pain in fibromyalgia patients: a systematic review. Ann Med. 2022 Dec;54(1):1403-1422. doi: 10.1080/07853890.2022.2075560.
PubMed 35579545Gholamrezaei A, Van Diest I, Aziz Q, Vlaeyen JWS, Van Oudenhove L. Controlled breathing and pain: Respiratory rate and inspiratory loading modulate cardiovascular autonomic responses, but not pain. Psychophysiology. 2021 Oct;58(10):e13895. doi: 10.1111/psyp.13895. Epub 2021 Jul 6.
PubMed 34231231Ichesco E, Puiu T, Hampson JP, Kairys AE, Clauw DJ, Harte SE, Peltier SJ, Harris RE, Schmidt-Wilcke T. Altered fMRI resting-state connectivity in individuals with fibromyalgia on acute pain stimulation. Eur J Pain. 2016 Aug;20(7):1079-89. doi: 10.1002/ejp.832. Epub 2016 Jan 15.
PubMed 26773435
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perception of Improvement Provided Virtual Reality Environment on Symptom Presence and Severity in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06508385
- Acronym / sponsor ID
- 2023/0689
- Conditions
- Fibromyalgia
- Keywords
- functional brain activity, Pain, Tissue properties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 18 Jul 2024 (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.
Fibromyalgia (FM) is a chronic pain syndrome characterized by impaired perception, transmission, and processing of nociceptive stimuli and causing widespread pain. Pain in FM is the disease itself and is characterized by nociplastic pain that may occur independently of any peripheral nociceptor activity or be felt without disease or damage to the somatosensory system. It is thought that the pain processing process is disrupted due to the changing neurotransmitter release activity and this situation causes pain to be felt more in FM. Chronic pain is the result of perception alteration associated with nociceptive afferent information affecting the cortex; underlying this change are limbic emotional learning mechanisms. Numerous factors, including emotional state, attention, and past painful experiences, modulate nociceptive inputs with the activation of multiple brain regions, resulting in a personalized pain experience. The chronic pain management program should target the central nervous system rather than the peripheral tissues because pain originates in the sensitized nervous system. For this reason, it is important to include plasticity-oriented approaches, cortical disinhibition methods, and strategies for improving perception and behavior change, which aim to replace negative beliefs with positive beliefs, into clinical practice. Our project aims to investigate the effectiveness of the therapeutic intervention, which consists of patient education supported Neuro-Linguistic Programming (NLP), visual feedback and metaphor-assisted breathing therapy designed to provide a perception of improvement and presented in a virtual reality environment, on pain processing, pain intensity, pain-pressure threshold, psychosomatic reflections (biomechanical and viscoelastic properties of tissue, sleep quality, pain catastrophizing behavior, anxiety and depression), disease impact and quality of life in FM patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Breathing exerciseNLP-supported patient education will be given and breath therapy will be applied to the Control Group |
| Virtual Reality Group-1 | Experimental | Other: Breathing exerciseNLP-supported patient education will be given. Visual feedback and metaphor-assisted breathing therapy over the three most painful points in the McGill-Melzack Pain Scale (real painful points) were given to this group in virtual reality environment. |
| Virtual Reality Group-2 | Experimental | Other: Breathing exerciseNLP-supported patient education will be given. Visual feedback and metaphor-assisted breathing therapy over the contralateral of the points reported as the three most painful points in the McGill-Melzack Pain Scale (virtual painful points) to this group in a virtual reality environment |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosed with Fibromyalgia at least 1 year ago according to ACR criteria
- Age range 25-55
- Female
- Scored at least 24 on the Mini-Mental State Assessment Test
- Reported weekly pain intensity of at least 40 mm on the Visual Analog Scale
Key exclusion criteria (6 listed)
- Having inflammatory rheumatic disease, malignancy, neurological disease, connective tissue disease, severe anemia, uncontrolled endocrine diseases
- Body Mass Index (BMI) ≥ 30 Kg/m2
- Being pregnant
- Having inability to understand, read and speak Turkish
- Having difficulty in hearing and seeing
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 |
|---|---|---|
| Breathing exerciseBreathing exercises will include; 1. Correct posture and sitting 2. Nose opening techniques 3. Diaphragmatic breathing, which consists of continuous and deep nasal inspiration with movement of the abdominal region and diaphragm 4. Main Breathing exercise (during 5 minutes)=inspiration (during 5 seconds) + expiration (during 15 seconds). | Other | Control Group, Virtual Reality Group-1, Virtual Reality Group-2 |
Primary outcome
Functional Magnetic Resonance
Time frame: Measurement of changes from baseline process of processing pain will be measured at 6 week and 10 week
The process of processing pain will be determined by functional magnetic resonance imaging performed immediately before and after the experimental pressure pain. ROI analysis will ve performed. No score is defined.
Measurement of pain-pressure threshold
Time frame: Measurement of changes from baseline of pain-pressure threshold will be measured at 6 week and 10 week
Pain-pressure threshold evaluated with a pain threshold measuring device (Algometer).
11 secondary outcomes
Sleep Quality
Time frame: Measurement of changes from baseline of sleep quality will be measured at 6 week and 10 week
Functional status and disease impact
Time frame: Measurement of changes from baseline of functional status and disease impact will be measured at 6 week and 10 week.
Quality of Life of patients
Time frame: Measurement of changes from baseline of quality of life will be measured at 6 week and 10 week
Anxiety and Depression Status
Time frame: Measurement of changes from baseline of anxiety and depression status will be measured at 6 week and 10 week
Pain catastrophizing behavior
Time frame: Measurement of changes from baseline of changes from baseline of pain catastrophizing behaviors will be measured at 6 week and 10 week
Patient satisfaction
Time frame: Measurement of changes from baseline of patient satisfaction will be measured at 6 week and 10 week
Measurement of biomechanical characteristics of tissue
Time frame: Measurement of changes from baseline stiffness values of tissue will be measured at 6 week and 10 week]
Measurement of biomechanical characteristics of tissue
Time frame: Measurement of changes from baseline tone values of tissue will be measured at 6 week and 10 week]
Measurement of biomechanical characteristics of tissue
Time frame: Measurement of changes from baseline decrement values of tissue will be measured at 6 week and 10 week]
Measurement of viscoelastic characteristics of tissue
Time frame: Measurement of changes from baseline creep values of tissue will be measured at 6 week and 10 week]
Measurement of viscoelastic characteristics of tissue
Time frame: Measurement of changes from baseline relaxation time values of tissue will be measured at 6 week and 10 week]
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 27 Oct 2026.
- Results publication: PubMed 26088211Adams LM, Turk DC. Psychosocial factors and central sensitivity syndromes. Curr Rheumatol Rev. 2015;11(2):96-108. doi: 10.2174/1573397111666150619095330.
- Results publication: PubMed 30453109Arnold LM, Bennett RM, Crofford LJ, Dean LE, Clauw DJ, Goldenberg DL, Fitzcharles MA, Paiva ES, Staud R, Sarzi-Puttini P, Buskila D, Macfarlane GJ. AAPT Diagnostic Criteria for Fibromyalgia. J Pain. 2019 Jun;20(6):611-628. doi: 10.1016/j.jpain.2018.10.008. Epub 2018 Nov 16.
- Results publication: PubMed 32616375Caneiro JP, Bunzli S, O'Sullivan P. Beliefs about the body and pain: the critical role in musculoskeletal pain management. Braz J Phys Ther. 2021 Jan-Feb;25(1):17-29. doi: 10.1016/j.bjpt.2020.06.003. Epub 2020 Jun 20.
- Results publication: PubMed 36749869Ciaramella A. Hypnotic analgesia in chronic pain: role of psychopathology and alexithymia. Am J Clin Hypn. 2023 Apr;65(4):299-313. doi: 10.1080/00029157.2022.2161868. Epub 2023 Feb 7.
- Results publication: PubMed 35579545de la Coba P, Montoro CI, Reyes Del Paso GA, Galvez-Sanchez CM. Algometry for the assessment of central sensitisation to pain in fibromyalgia patients: a systematic review. Ann Med. 2022 Dec;54(1):1403-1422. doi: 10.1080/07853890.2022.2075560.
- Results publication: PubMed 34231231Gholamrezaei A, Van Diest I, Aziz Q, Vlaeyen JWS, Van Oudenhove L. Controlled breathing and pain: Respiratory rate and inspiratory loading modulate cardiovascular autonomic responses, but not pain. Psychophysiology. 2021 Oct;58(10):e13895. doi: 10.1111/psyp.13895. Epub 2021 Jul 6.
- Results publication: PubMed 26773435Ichesco E, Puiu T, Hampson JP, Kairys AE, Clauw DJ, Harte SE, Peltier SJ, Harris RE, Schmidt-Wilcke T. Altered fMRI resting-state connectivity in individuals with fibromyalgia on acute pain stimulation. Eur J Pain. 2016 Aug;20(7):1079-89. doi: 10.1002/ejp.832. Epub 2016 Jan 15.
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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.
Nilüfer Kablan, PhD principal investigator
İstanbul Medeniyet Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise in people with Fibromyalgia, run by Istanbul Medeniyet 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 6 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 27 Oct 2026. 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?
Functional Magnetic Resonance (time frame: Measurement of changes from baseline process of processing pain will be measured at 6 week and 10 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06508385, which also lists 7 linked publications.
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 27 Oct 2026.