An observational study in Fibromyalgia, sponsored by Centre Hospitalier Princesse Grace. Active, not recruiting at 1 site in Monaco. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Centre Hospitalier Princesse Grace · Observational
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.
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
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 279 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Centre Hospitalier Princesse Grace is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with fibromyalgia pain > 6 months
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient pain
Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain
Time frame: month 1
Patient pain
Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain
Time frame: week 2, month 2
Activity
pain self-efficacy questionnaire, 0 to 60, 0 = not at all confident, 60 = completely confident
Time frame: 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
Time frame: 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
Time frame: month 1, month 2
Ran from Oct 2022 to primary completion in Dec 2024, 25 months.
Of 81 non-industry observational studies under Fibromyalgia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 109. This study's 25 months is close to that.
Counting every sponsor, half of 88 studies reached it within 27 months; a quarter within 8 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Princesse Grace