FibromyalgiaVR_FibroNCT05567861
Virtual Reality for Fibromyalgia
An observational study of Fibromyalgia, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
Trial summary
Fibromyalgia is a frequent chronic pain syndrome almost often affecting women and associating diffuse chronic musculoskeletal pain (for more than 3 months), fatigue and sleep disturbances. Other varied functional symptoms are associated with it, in particular cognitive disorders and a feeling of unrested awakening. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- How many people
- 60 participants
- Where
- 1 siteMonaco
- Study dates
- 11 Oct 2022to Sep 2025
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with fibromyalgia pain > 6 months
Who may be able to join
- Patients able to understand and sign the informed consent form for the study
- Adults aged 18 to 65 years
- Followed in algology for fibromyalgia pain > 6 months
- With mean pain intensity ≥ 4
Who cannot join
- History of epilepsy or hypersensitivity to flashing light to limit the risk of virtual reality-induced seizures
- Previous use of VR for pain (possible bias)
- Refusal to participate
- Therapeutic modifications for pain management related to fibromyalgia during the first month of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Effect of Virtual Reality on the Pain Intensity of Patients Suffering From Fibromyalgia
Fibromyalgia is a frequent chronic pain syndrome almost often affecting women and associating diffuse chronic musculoskeletal pain (for more than 3 months), fatigue and sleep disturbances. Other varied functional symptoms are associated with it, in particular cognitive disorders and a feeling of unrested awakening.
Technological advances in virtual reality have led to recognition by the medical community as a way to improve pain and quality of life for patients.
There is a growing body of evidence supporting the use of virtual reality as an adjunct therapy to reduce acute pain in patients during medical procedures in hospital settings. There may also be a role for virtual reality in patients with chronic pain.
Read the detailed description
Current treatments for fibromyalgia (FM) include pharmaceutical pain medications as well as psychological programs with components of cognitive therapy, and activity management. However, pain medications are not fully effective, can be addictive, and can cause hyperalgesia. Non-pharmacological treatments for chronic pain may be associated with limiting side effects, technology-based interventions using virtual reality (VR) may be a promising alternative treatment option.
There is evidence which shows that VR can be an effective treatment for pain reduction. However, most studies which utilize VR as a method of pain reduction focus on acute pain and studies looking at VR for chronic pain are scarce.
Investigator will analyze the pain reduction and impact on behavioral mechanisms and cognition with repetitive active VR on Fibromyalgia
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Virtual Reality, Chronic Pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient pain
Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain
Measured: month 1
Secondary outcomes (4)
Patient pain
Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain
Measured: week 2, month 2
Activity
pain self-efficacy questionnaire, 0 to 60, 0 = not at all confident, 60 = completely confident
Measured: month 1, month 2
Mood
Hospital Anxiety and Depression scale, 0 to 42, 7 or less = no symptom, 8 to 10 = doubt on symptom, 11 and more = undeniable symptom
Measured: month 1, month 2
Pain associated cognition
Catastrophizing scale, 0 to 52, higher score indicates higher level of catastrophizing, a total score above 30 indicates clinically relevant level of catastrophizing
Measured: month 1, month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start11 Oct 2022
- Primary completion1 Dec 2024
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567861
- Sponsor's protocol ID
- 22-20
- Acronym
- VR_Fibro
- Status last verified
- Mar 2025
- First submitted
- 3 Oct 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Amodeo JM, Berthier F, Biehlmann C, Piazza B. Repeated virtual reality sessions in fibromyalgia: a prospective observational study. Pain Manag. 2026 Jun;16(6):633-643. doi: 10.1080/17581869.2026.2635978. Epub 2026 Mar 2.
PubMed 41766477
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Effect of Virtual Reality on the Pain Intensity of Patients Suffering From Fibromyalgia
- ClinicalTrials.gov ID
- NCT05567861
- Acronym / sponsor ID
- VR_Fibro / 22-20
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Virtual Reality, Chronic Pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 5 Oct 2022 (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 is a frequent chronic pain syndrome almost often affecting women and associating diffuse chronic musculoskeletal pain (for more than 3 months), fatigue and sleep disturbances. Other varied functional symptoms are associated with it, in particular cognitive disorders and a feeling of unrested awakening.
Technological advances in virtual reality have led to recognition by the medical community as a way to improve pain and quality of life for patients.
There is a growing body of evidence supporting the use of virtual reality as an adjunct therapy to reduce acute pain in patients during medical procedures in hospital settings. There may also be a role for virtual reality in patients with chronic pain.
Detailed description
Current treatments for fibromyalgia (FM) include pharmaceutical pain medications as well as psychological programs with components of cognitive therapy, and activity management. However, pain medications are not fully effective, can be addictive, and can cause hyperalgesia. Non-pharmacological treatments for chronic pain may be associated with limiting side effects, technology-based interventions using virtual reality (VR) may be a promising alternative treatment option.
There is evidence which shows that VR can be an effective treatment for pain reduction. However, most studies which utilize VR as a method of pain reduction focus on acute pain and studies looking at VR for chronic pain are scarce.
Investigator will analyze the pain reduction and impact on behavioral mechanisms and cognition with repetitive active VR on Fibromyalgia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with fibromyalgia pain > 6 months
Key inclusion criteria (4 listed)
- Patients able to understand and sign the informed consent form for the study
- Adults aged 18 to 65 years
- Followed in algology for fibromyalgia pain > 6 months
- With mean pain intensity ≥ 4
Key exclusion criteria (4 listed)
- History of epilepsy or hypersensitivity to flashing light to limit the risk of virtual reality-induced seizures
- Previous use of VR for pain (possible bias)
- Refusal to participate
- Therapeutic modifications for pain management related to fibromyalgia during the first month of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient pain
Time frame: month 1
Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain
4 secondary outcomes
Patient pain
Time frame: week 2, month 2
Activity
Time frame: month 1, month 2
Mood
Time frame: month 1, month 2
Pain associated cognition
Time frame: month 1, month 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Derived from this study: PubMed 41766477Amodeo JM, Berthier F, Biehlmann C, Piazza B. Repeated virtual reality sessions in fibromyalgia: a prospective observational study. Pain Manag. 2026 Jun;16(6):633-643. doi: 10.1080/17581869.2026.2635978. Epub 2026 Mar 2.
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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.
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?
An observational study of Fibromyalgia, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 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 Monaco. 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?
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?
Patient pain (time frame: month 1). 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 NCT05567861, which also lists 1 linked publication.
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 12 Mar 2025; AzTrials last refreshed its copy on 28 Oct 2026.