Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-01-03 @ 2:40 AM
Study NCT ID:
NCT05567861
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2022-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality for Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient pain', 'timeFrame': 'month 1', 'description': 'Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain'}], 'secondaryOutcomes': [{'measure': 'Patient pain', 'timeFrame': 'week 2, month 2', 'description': 'Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain'}, {'measure': 'Activity', 'timeFrame': 'month 1, month 2', 'description': 'pain self-efficacy questionnaire, 0 to 60, 0 = not at all confident, 60 = completely confident'}, {'measure': 'Mood', 'timeFrame': 'month 1, month 2', 'description': 'Hospital Anxiety and Depression scale, 0 to 42, 7 or less = no symptom, 8 to 10 = doubt on symptom, 11 and more = undeniable symptom'}, {'measure': 'Pain associated cognition', 'timeFrame': 'month 1, month 2', 'description': 'Catastrophizing scale, 0 to 52, higher score indicates higher level of catastrophizing, a total score above 30 indicates clinically relevant level of catastrophizing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Virtual Reality', 'Chronic Pain'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': '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.\n\nTechnological advances in virtual reality have led to recognition by the medical community as a way to improve pain and quality of life for patients.\n\nThere 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.', 'detailedDescription': '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.\n\nThere 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.\n\nInvestigator will analyze the pain reduction and impact on behavioral mechanisms and cognition with repetitive active VR on Fibromyalgia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with fibromyalgia pain \\> 6 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Patients able to understand and sign the informed consent form for the study\n* Adults aged 18 to 65 years\n* Followed in algology for fibromyalgia pain \\> 6 months\n* With mean pain intensity ≥ 4\n\nExclusion Criteria :\n\n* History of epilepsy or hypersensitivity to flashing light to limit the risk of virtual reality-induced seizures\n* Previous use of VR for pain (possible bias)\n* Refusal to participate\n* Therapeutic modifications for pain management related to fibromyalgia during the first month of participation'}, 'identificationModule': {'nctId': 'NCT05567861', 'acronym': 'VR_Fibro', 'briefTitle': 'Virtual Reality for Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Princesse Grace'}, 'officialTitle': 'Observational Study on the Effect of Virtual Reality on the Pain Intensity of Patients Suffering From Fibromyalgia', 'orgStudyIdInfo': {'id': '22-20'}}, 'contactsLocationsModule': {'locations': [{'zip': '98000', 'city': 'Monaco', 'country': 'Monaco', 'facility': 'Centre Hospitalier Princesse Grace', 'geoPoint': {'lat': 43.73718, 'lon': 7.42145}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Princesse Grace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}