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Fibromyalgia PatientsNCT07528599

Virtual Reality-based Motor Imagery in Patients With Fibromyalgia

A study testing conventional exercise + motor imagery without virtual reality and conventional exercise + motor imagery with virtual reality in people with Fibromyalgia Patients, run by Inonu University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study investigated the effects of a virtual reality-based motor imagery intervention integrated into a conventional exercise programme on pain outcomes (pain intensity, central sensitisation, pressure pain threshold, galvanic skin response, pain catastrophising), quality of life, sleep quality, fatigue… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Fibromyalgia Patients
What is being tested?
conventional exercise + motor imagery without virtual reality and conventional exercise + motor imagery with virtual reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Mar 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • To be a volunteer,
  • To have been diagnosed with fibromyalgia according to the 2016 ACR diagnostic criteria,
  • To be aged between 18 and 60,
  • To have had pain symptoms for at least 3 months,
  • To be receiving standard medical treatment,

Who cannot join

  • The presence of neurological or orthopaedic conditions that would prevent participation in the rehabilitation programme
  • Pregnancy,
  • The presence of cognitive impairments that could affect cooperation,
  • The presence of serious, uncontrolled health problems,
  • A history of lower limb or spinal surgery
  • Visual or hearing impairments;
Show all 10Show fewer
  • Serious psychiatric disorders
  • A diagnosis of migraine
  • Regular physical exercise in the last three months (≥2 days per week)
  • Participation in any concurrent physiotherapy or rehabilitation intervention

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Inonu University

    Malatya

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Virtual Reality-Based Motor Imagery on Pain, Psychological Status and Quality of Life in Fibromyalgia Patients

This study investigated the effects of a virtual reality-based motor imagery intervention integrated into a conventional exercise programme on pain outcomes (pain intensity, central sensitisation, pressure pain threshold, galvanic skin response, pain catastrophising), quality of life, sleep quality, fatigue, psychological outcomes (Hospital Anxiety and Depression Scale), imagery ability and patient satisfaction.

Read the detailed description

The study will include individuals aged 18-60 who have been diagnosed with fibromyalgia. Participants will be randomly assigned to one of two groups using a sealed-envelope method: the traditional exercise + virtual reality-assisted motor imagery group, or the traditional exercise + non-virtual reality motor imagery group. In both groups, participants will undergo a traditional rehabilitation programme three days a week under the supervision of a physiotherapist. In the experimental group, three virtual reality games targeting the upper extremities, trunk and lower extremities will be shown for three minutes each, followed by two minutes of motor imagery. In the control group, the same protocol will be carried out via a monitor without virtual reality. All assessments will be conducted before treatment and at the end of 6 weeks. Pain intensity, Visual Analogue Scale; central sensitivity, Central Sensitivity Inventory; pain catastrophising, Pain Catastrophising Scale; general quality of life, Fibromyalgia Impact Questionnaire; pressure pain threshold, algometer; sleep quality, Pittsburgh Sleep Quality Index; fatigue severity, Fatigue Severity Scale; psychological state, Hospital Anxiety and Depression Scale; patient satisfaction, Patient's General Impression of Change Scale; and imagery ability, Kinesthetic and Visual Imagery Questionnaire-10.

Being tested
conventional exercise + motor imagery without virtual reality, conventional exercise + motor imagery with virtual reality
Keywords
Fibromyalgia, motor imagery, exercise, rehabilitation, virtual reality
Medical subject headings
Fibromyalgia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional exercise + motor imagery without virtual realityOther

    Also called control group

    Participants in the control groups will undergo a structured conventional exercise programme under the supervision of a physiotherapist, three days a week for six weeks. The conventional exercise programme has been designed to include stretching, postural control and muscle strengthening components. Each session will last approximately 30 minutes. The intensity and difficulty level of the exercises will be gradually increased every two weeks and progressed in a controlled manner. In the control group, recorded versions of virtual reality games will be presented via a standard monitor screen without the use of a virtual reality headset. Participants will watch each video for three minutes and will then be asked to visualise the same movements for two minutes. The total duration of the motor imagery intervention in the control group will also be 15 minutes.

  • conventional exercise + motor imagery with virtual realityOther

    Also called experimental group

    A structured conventional exercise programme will be implemented three days a week for six weeks. The conventional exercise programme has been designed to include components of stretching, postural control and muscle strengthening. Each session will last approximately 30 minutes. The intensity and difficulty level of the exercises will be gradually increased every two weeks and progressed in a controlled manner. In the experimental group, motor imagery exercises will be performed by creating a virtual environment using the provided virtual reality headset. In this group, a total of three different virtual reality games targeting the upper limbs, trunk and lower limbs will be used. Each game will be viewed for three minutes via the virtual reality headset, after which participants will be asked to mentally visualise the relevant movements for two minutes. The total duration of the motor imagery intervention is planned to be 15 minutes.

Study groups in NCT07528599
Study groupRoleWhat they receive
conventional exercise + motor imagery without virtual realityActive comparatorParticipants will undergo a traditional rehabilitation programme three days a week under the supervision of a physiotherapist. Three virtual reality games targeting the upper limbs, trunk and lower limbs will be used; participants will watch these games on a monitor and visualise the movements.
Receives: Other: conventional exercise + motor imagery without virtual reality
conventional exercise + motor imagery with virtual realityExperimentalParticipants will undergo a traditional rehabilitation programme three days a week under the supervision of a physiotherapist. Participants will watch three virtual reality games, each lasting three minutes and targeting the upper limbs, trunk and lower limbs, and will then perform motor imagery for two minutes.
Receives: Other: conventional exercise + motor imagery with virtual reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain assessment

    Pain during rest and activity will be assessed using the VAS. The VAS is a 10-cm scale where 0 points indicate 'no pain' and 10 points indicate 'the worst pain imaginable'. Participants will be asked to mark the scale based on their assessment of pain intensity over the past 24 hours. Pain intensity will be measured using the scale and recorded in centimetres.

    Measured: baseline

  2. pain assessment

    Pain during rest and activity will be assessed using the VAS. The VAS is a 10-cm scale where 0 points indicate 'no pain' and 10 points indicate 'the worst pain imaginable'. Participants will be asked to mark the scale based on their assessment of pain intensity over the past 24 hours. Pain intensity will be measured using the scale and recorded in centimetres.

    Measured: 6 weeks

Secondary outcomes (20)
  1. Pressure Pain Threshold Assessment

    An algometer will be used to assess the pressure pain threshold. During the assessment, tender points at the occipital base, lower cervical region, trapezius, supraspinatus, second costochondral joint, lateral epicondyle and medial knee border will be measured bilaterally. In addition, the patient will be asked to stand upright so that the tender points of the gluteus and greater trochanter can also be assessed. Each measurement will be repeated three times bilaterally, and the average of the values obtained will be recorded.

    Measured: Baseline

  2. Pressure pain threshold assessment

    An algometer will be used to assess the pressure pain threshold. During the assessment, tender points at the occipital base, lower cervical region, trapezius, supraspinatus, second costochondral joint, lateral epicondyle and medial knee border will be measured bilaterally. In addition, the patient will be asked to stand upright so that the tender points of the gluteus and greater trochanter can also be assessed. Each measurement will be repeated three times bilaterally, and the average of the values obtained will be recorded.

    Measured: 6 weeks

  3. Galvanic Skin Response

    Galvanic skin response is an important physiological parameter that measures changes in the electrical conductivity of the skin surface and reflects sympathetic nervous system activity. It is frequently used as a non-invasive, reliable and sensitive method for assessing autonomic nervous system responses. In this study, galvanic skin response measurements will be carried out using a galvanic skin response sensor to be acquired as part of the project, with the aim of objectively evaluating the effects of a virtual reality-based motor imagery intervention on autonomic physiological responses. The galvanic skin response will be recorded.

    Measured: Baseline

  4. Galvanic Skin Response

    Galvanic skin response is an important physiological parameter that measures changes in the electrical conductivity of the skin surface and reflects sympathetic nervous system activity. It is frequently used as a non-invasive, reliable and sensitive method for assessing autonomic nervous system responses. In this study, galvanic skin response measurements will be carried out using a galvanic skin response sensor to be acquired as part of the project, with the aim of objectively evaluating the effects of a virtual reality-based motor imagery intervention on autonomic physiological responses. The galvanic skin response will be recorded .

    Measured: 6 weeks

  5. Central Sensitivity Inventory

    The Central Sensitivity Inventory is a patient-completed questionnaire used to assess the severity of central sensitivity symptoms associated with chronic pain. The questionnaire consists of 9 items, each of which examines pain and associated symptoms originating from the central nervous system. High scores on the scale indicate that symptoms of central sensitisation are more pronounced and severe; low scores, on the other hand, indicate a milder level of central sensitisation.

    Measured: Baseline

  6. Central Sensitivity Inventory

    The Central Sensitivity Inventory is a patient-completed questionnaire used to assess the severity of central sensitivity symptoms associated with chronic pain. The questionnaire consists of 9 items, each of which examines pain and associated symptoms originating from the central nervous system. High scores on the scale indicate that symptoms of central sensitisation are more pronounced and severe; low scores, on the other hand, indicate a milder level of central sensitisation.

    Measured: 6 weeks

  7. Pain Catastrophising Scale

    A 13-item self-report instrument that assesses individuals' catastrophising regarding pain, i.e. their negative cognitive and emotional responses. The scale covers the dimensions of pain exaggeration, feelings of helplessness and persistent negative thoughts. A high score is associated with an intensified perception of pain in patients with chronic pain .

    Measured: Baseline

  8. Pain Catastrophising Scale

    A 13-item self-report instrument that assesses individuals' catastrophising regarding pain, i.e. their negative cognitive and emotional responses. The scale covers the dimensions of pain exaggeration, feelings of helplessness and persistent negative thoughts. A high score is associated with an intensified perception of pain in patients with chronic pain

    Measured: 6 weeks

  9. Revised Fibromyalgia Impact Questionnaire

    The Revised Fibromyalgia Impact Questionnaire is used to assess the overall impact of fibromyalgia on a patient's daily life, functional status and symptom burden. It is a reliable and valid tool for monitoring disease severity and response to treatment in both clinical practice and research. The scale consists of three sub-sections: functional status, overall impact and symptoms, and contains a total of 21 items. Items are scored on a scale of 0-10, and the sub-sections are adjusted using specific weightings to produce an overall score out of 100. A higher score is associated with a more severe clinical presentation and a lower quality of life.

    Measured: Baseline

  10. Revised Fibromyalgia Impact Questionnaire

    The Revised Fibromyalgia Impact Questionnaire is used to assess the overall impact of fibromyalgia on a patient's daily life, functional status and symptom burden. It is a reliable and valid tool for monitoring disease severity and response to treatment in both clinical practice and research. The scale consists of three sub-sections: functional status, overall impact and symptoms, and contains a total of 21 items. Items are scored on a scale of 0-10, and the sub-sections are adjusted using specific weightings to produce an overall score out of 100. A higher score is associated with a more severe clinical presentation and a lower quality of life.

    Measured: 6 weeks

  11. Hospital Anxiety and Depression Scale

    The Hospital Anxiety and Depression Scale is used to measure patients' levels of anxiety and depression. It is a self-report scale comprising a total of 14 items. Seven items assess anxiety levels, whilst the other seven assess depression levels. Each item is scored on a scale of 0 to 3 using a 4-point Likert-type scale. The cut-off value is set at 10 for anxiety and 7 for depression.

    Measured: Baseline

  12. Hospital Anxiety and Depression Scale

    The Hospital Anxiety and Depression Scale is used to measure patients' levels of anxiety and depression. It is a self-report scale comprising a total of 14 items. Seven items assess anxiety levels, whilst the other seven assess depression levels. Each item is scored on a scale of 0 to 3 using a 4-point Likert-type scale. The cut-off value is set at 10 for anxiety and 7 for depression.

    Measured: 6 weeks

  13. Pittsburgh Sleep Quality Index

    The Pittsburgh Sleep Quality Index will be used to assess sleep quality over the past month. It consists of a total of 24 questions, 18 of which are answered by the individual, and the assessment is based on seven components: subjective sleep quality, time taken to fall asleep, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime functional impairment. Each item is scored on a scale of 0-3, and the sum of the component scores forms the overall sleep quality score. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

    Measured: Baseline

  14. Pittsburgh Sleep Quality Index

    The Pittsburgh Sleep Quality Index will be used to assess sleep quality over the past month. It consists of a total of 24 questions, 18 of which are answered by the individual, and the assessment is based on seven components: subjective sleep quality, time taken to fall asleep, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime functional impairment. Each item is scored on a scale of 0-3, and the sum of the component scores forms the overall sleep quality score. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

    Measured: 6 weeks

  15. Fatigue Severity Scale

    The Fatigue Severity Scale assesses individuals' levels of fatigue over the past month. It is a 9-item self-report instrument. Each item is scored on a scale of 1 to 7, with higher scores indicating greater fatigue severity .

    Measured: Baseline

  16. Fatigue Severity Scale

    The Fatigue Severity Scale assesses individuals' levels of fatigue over the past month. It is a 9-item self-report instrument. Each item is scored on a scale of 1 to 7, with higher scores indicating greater fatigue severity.

    Measured: 6 weeks

  17. Patient's General Perception of Change Scale

    Following completion of the exercise programme, patients will be asked to assess changes in their symptoms before and after treatment. The 7-point Likert-scale PGPCS will be used to subjectively measure patients' response to treatment. The scale allows patients to rate changes in their general health status as follows: 1) improved considerably, 2) improved a lot, 3) improved slightly, 4) no change, 5) slightly worse, 6) worse, 7) much worse. It is widely used in clinical trials and routine practice to assess patients' response to treatment quickly and effectively.

    Measured: Baseline

  18. Patient's General Perception of Change Scale

    Following completion of the exercise programme, patients will be asked to assess changes in their symptoms before and after treatment. The 7-point Likert-scale PGPCS will be used to subjectively measure patients' response to treatment. The scale allows patients to rate changes in their general health status as follows: 1) improved considerably, 2) improved a lot, 3) improved slightly, 4) no change, 5) slightly worse, 6) worse, 7) much worse. It is widely used in clinical trials and routine practice to assess patients' response to treatment quickly and effectively.

    Measured: 6 weeks

  19. Kinesthetic and Visual Imagery Questionnaire

    The Kinesthetic and Visual Imagery Questionnaire aims to determine the extent to which individuals can visualise and kinesthetically perceive the movements they imagine. All items are administered whilst the participant is seated and consist of two subscales: visual imagery and kinesthetic imagery. In the Kinesthetic and Visual Imagery Questionnaire, each item is scored on a scale of 1-5 (1 = no sensation/image, 5 = as intense as if performing the movement/as clear as the real thing), with the total score ranging from 10 to 50; higher scores indicate better imagery ability.

    Measured: Baseline

  20. Kinesthetic and Visual Imagery Questionnaire

    The Kinesthetic and Visual Imagery Questionnaire aims to determine the extent to which individuals can visualise and kinesthetically perceive the movements they imagine. All items are administered whilst the participant is seated and consist of two subscales: visual imagery and kinesthetic imagery. In the Kinesthetic and Visual Imagery Questionnaire, each item is scored on a scale of 1-5 (1 = no sensation/image, 5 = as intense as if performing the movement/as clear as the real thing), with the total score ranging from 10 to 50; higher scores indicate better imagery ability.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start25 Mar 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07528599
Sponsor's protocol ID
2026/9676
Status last verified
Apr 2026
First submitted
7 Apr 2026
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing conventional exercise + motor imagery without virtual reality and conventional exercise + motor imagery with virtual reality in people with Fibromyalgia Patients, 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 14 Apr 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Büşra CANDİRİ (+905073780717, candiri_17@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain assessment (time frame: baseline). 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?
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 14 Apr 2026.

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