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Virtual Reality for Fibromyalgia

Observational Study on the Effect of Virtual Reality on the Pain Intensity of Patients Suffering From Fibromyalgia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05567861
Acronym
VR_Fibro
Enrollment
60
Registered
2022-10-05
Start date
2022-10-11
Completion date
2025-09-30
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Virtual Reality, Chronic Pain

Brief 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. 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

Interventions

None listed

Sponsors

Centre Hospitalier Princesse Grace
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

: * 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

Exclusion criteria

: * 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

Design outcomes

Primary

MeasureTime frameDescription
Patient painmonth 1Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain

Secondary

MeasureTime frameDescription
Patient painweek 2, month 2Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain
Activitymonth 1, month 2pain self-efficacy questionnaire, 0 to 60, 0 = not at all confident, 60 = completely confident
Moodmonth 1, month 2Hospital Anxiety and Depression scale, 0 to 42, 7 or less = no symptom, 8 to 10 = doubt on symptom, 11 and more = undeniable symptom
Pain associated cognitionmonth 1, month 2Catastrophizing scale, 0 to 52, higher score indicates higher level of catastrophizing, a total score above 30 indicates clinically relevant level of catastrophizing

Countries

Monaco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026