Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-29 @ 5:54 PM
Study NCT ID:
NCT06312735
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR for Patients With Chronic Pain (Wait & Work)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in quality of life measured using the short-form 12 (SF-12)', 'timeFrame': 'Baseline, directly after the intervention, and at six months follow-up', 'description': 'This questionnaire on quality of life scores from 12 (worst possible score) to 56 (best possible score)'}], 'secondaryOutcomes': [{'measure': 'Change in pain intensity measured using the numeric pain rating scale (NPRS)', 'timeFrame': 'Baseline, directly after the intervention, and at six months follow-up', 'description': 'This questionnaire on pain intensity scores from 0 (best possible score) to 100 (worst possible score)'}, {'measure': 'Change in pain catastrophizing measured using the pain catastrophizing scale (PCS)', 'timeFrame': 'Baseline, directly after the intervention, and at six months follow-up', 'description': 'This questionnaire on pain catastrophizing scores from 0 (best possible score) to 52 (worst possible score).'}, {'measure': 'Change in pain self-efficacy measured using the pain self-efficacy questionnaire (PSEQ)', 'timeFrame': 'Baseline, directly after the intervention, and at six months follow-up', 'description': 'This questionnaire scores from 0 (worst possible score) to 60 (best possible score).'}, {'measure': 'Change in pain acceptance measured using the chronic pain acceptance questionnaire (CPAQ-8)', 'timeFrame': 'Baseline, directly after the intervention, and at six months follow-up', 'description': 'This questionnaire scores from 0 (worst possible score) to 48 (best possible score).'}, {'measure': 'Change in feelings of anxiety and depression measured using the hospital anxiety and depression scale (HADS)', 'timeFrame': 'Baseline, directly after the intervention, and at six months follow-up', 'description': 'This questionnaire scores from 0 (worst possible score) to 42 (best possible score).'}, {'measure': 'Change in quality of care measured using the client satisfaction questionnaire (CSQ-8)', 'timeFrame': 'Baseline, directly after the intervention, and at six months follow-up', 'description': 'This questionnaire scores from 8 (worst possible score) to 32 (best possible score).'}, {'measure': 'Change in medication use measured using an open-ended question', 'timeFrame': 'Baseline, directly after the intervention, and at six months follow-up', 'description': 'This question inquires about current medication use'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This cluster-RCT evaluates the effect of therapeutic virtual reality (VR) on patients with chronic musculoskeletal pain (CMP) who are on a waiting list to receive pain treatment. The used VR application, Reducept, offers pain education and pain management techniques. This home-based, stand-alone, immersive VR intervention was used daily for four weeks in the intervention group. The control group received standard care (no treatment). Primary outcome measure for this study was health-related quality of life, secondary outcome measures included various pain-related variables (e.g. pain self-efficacy and acceptance. Outcome variables will be measured after four weeks and follow-up after six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 years or older\n* suffering from primary or secondary CMP\n* finished with biomedical diagnostics and treatment\n* open to biopsychosocial treatment\n* willing and capable of complying with study procedures.\n\nExclusion Criteria:\n\n* not able to finish the VR intervention due to physical (e.g. visual impairment), mental (e.g. severe sensitivity to stimuli) or practical problems (e.g. insufficient tech-literacy)\n* unable to finish Dutch questionnaires.'}, 'identificationModule': {'nctId': 'NCT06312735', 'briefTitle': 'VR for Patients With Chronic Pain (Wait & Work)', 'organization': {'class': 'OTHER', 'fullName': 'University of Twente'}, 'officialTitle': 'Cluster-randomized Controlled Trial of Virtual Reality for Patients With Chronic Musculoskeletal Pain (Wait & Work)', 'orgStudyIdInfo': {'id': '230405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Four-week, at-home VR intervention with a recommended daily use of 10-30 minutes', 'interventionNames': ['Device: VR (Reducept)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No intervention, patient is a waiting-list control'}], 'interventions': [{'name': 'VR (Reducept)', 'type': 'DEVICE', 'description': 'Reducept is a novel VR intervention that consists of a combination of pain neuroscience education (PNE) and pain management techniques. It includes different psychological therapy modalities (e.g. acceptance and commitment therapy (ACT), cognitive behavioral therapy (CBT) and hypnotherapy) into a single application.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7416SE', 'city': 'Deventer', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'Deventer Ziekenhuis', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}, {'zip': '7522AH', 'city': 'Enschede', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'Roessingh rehabilitation center', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '7555DL', 'city': 'Hengelo', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'Nocepta', 'geoPoint': {'lat': 52.26583, 'lon': 6.79306}}, {'zip': '8303BX', 'city': 'Emmeloord', 'state': 'Provincie Friesland', 'country': 'Netherlands', 'facility': 'Revalidatie Friesland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Twente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Monique Tabak', 'investigatorAffiliation': 'University of Twente'}}}}