Virtual Reality for Fibromyalgia (VR_Fibro)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fibromyalgia

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Monaco
  • Monaco, Monaco, 98000
    • Centre Hospitalier Princesse Grace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with fibromyalgia pain > 6 months

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient pain	Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain	month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient pain	Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain	week 2, month 2
Activity	pain self-efficacy questionnaire, 0 to 60, 0 = not at all confident, 60 = completely confident	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	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	month 1, month 2

Collaborators and Investigators

• Sponsor: Centre Hospitalier Princesse Grace

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): December 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Pain; Virtual Reality; Fibromyalgia
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 22-20