NCT05567861

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

October 11, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

October 3, 2022

Last Update Submit

March 10, 2025

Conditions

Fibromyalgia

Keywords

FibromyalgiaVirtual RealityChronic Pain

Outcome Measures

Primary Outcomes (1)

  • Patient pain

    Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain

    month 1

Secondary Outcomes (4)

  • Patient pain

    week 2, month 2

  • Activity

    month 1, month 2

  • Mood

    month 1, month 2

  • Pain associated cognition

    month 1, month 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with fibromyalgia pain \> 6 months

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

FibromyalgiaChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 5, 2022

Study Start

October 11, 2022

Primary Completion

December 1, 2024

Study Completion

September 1, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

MO(1)