Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-19 @ 7:13 AM
Study NCT ID:
NCT06697795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-20
First Post:
2024-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Neck Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck 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': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Intensity', 'timeFrame': 'Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups.', 'description': 'The primary outcome is the percentage change in pain intensity, measured using the Visual Analog Scale (VAS). A reduction of ≥30% in the VAS score from baseline is considered clinically significant.'}], 'secondaryOutcomes': [{'measure': 'Change in Functional Status', 'timeFrame': 'Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.', 'description': 'Functional status will be assessed using the Neck Disability Index (NDI). Improvement in NDI scores reflects better functionality and reduced disability related to chronic neck pain.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.', 'description': 'Quality of life will be measured using the Short Form-12 (SF-12) questionnaire.'}, {'measure': 'Reduction in Analgesic Use', 'timeFrame': 'Baseline and weekly throughout the 3-month follow-up period.', 'description': 'The number of days per week participants use nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen for pain management will be recorded.'}, {'measure': 'Change in Anxiety and Depression Levels', 'timeFrame': 'Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.', 'description': 'Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS).'}, {'measure': 'Reduction in Healthcare Utilization', 'timeFrame': 'Assessed retrospectively at baseline and at the 3-month follow-up.', 'description': 'Healthcare utilization, including the number of clinic visits (Family Medicine, Physical Therapy, Orthopedics) and cervical imaging (X-ray, MRI), will be recorded for the 3 months prior to and after the intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypnotherapy', 'virtual reality'], 'conditions': ['Chronic Neck Pain', 'Neck Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://hypnovr.io/en/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This randomized, prospective study aims to evaluate the effectiveness and cost-efficiency of a Virtual Reality (VR)-assisted hypnotherapy program on quality of life in patients with chronic neck pain. The study compares a VR-assisted hypnotherapy group to a standard treatment group. Both groups will undergo a conventional physical therapy program supervised by physiotherapists for 3 weeks (15 sessions). The VR-assisted hypnotherapy group will receive additional sessions utilizing the HypnoVR software, which delivers relaxing virtual environments. Outcomes will be assessed immediately after treatment, at 1 month, and at 3 months post-treatment. Primary endpoints include pain reduction measured by the Visual Analog Scale (VAS). Secondary endpoints include functionality, quality of life, anxiety, depression, sleep quality, healthcare costs, and treatment adherence. Statistical analyses will determine the efficacy and economic impact of this innovative therapy for chronic neck pain management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 50 and 80 years.\n* Chronic neck pain lasting for more than 3 months.\n\nExclusion Criteria:\n\n* History of spinal surgery.\n* Beck Depression Inventory (BDI) score \\>16.\n* Presence of neurological deficits or concurrent neurological diseases.\n* Medical conditions incompatible with the use of VR headsets (e.g., vision problems, epilepsy).\n* Pregnancy.\n* Recent changes in medication for chronic pain within the past 3 months (e.g.,- Pregabalin, Gabapentin, Duloxetine).'}, 'identificationModule': {'nctId': 'NCT06697795', 'briefTitle': 'Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Neck Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Beykent'}, 'officialTitle': 'Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Neck Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study', 'orgStudyIdInfo': {'id': 'E-66291034-202.3.02-6297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality-Assisted Hypnotherapy+Physiotherapy Group', 'description': 'Participants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists. Additionally, during each physical therapy session, participants will receive a 20-minute Virtual Reality (VR)-assisted hypnotherapy session using the HypnoVR software.', 'interventionNames': ['Device: Virtual Reality-Assisted Hypnotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Treatment Group', 'description': 'Participants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists.', 'interventionNames': ['Other: Standard Physical Therapy']}], 'interventions': [{'name': 'Virtual Reality-Assisted Hypnotherapy', 'type': 'DEVICE', 'description': 'Virtual Reality-Assisted Hypnotherapy utilizes HypnoVR software delivered through VR glasses to provide a relaxing virtual environment. The intervention is integrated into a standard physical therapy program, with participants receiving 20-minute VR-assisted hypnotherapy sessions during each of the 15 supervised physical therapy sessions over a 3-week period. This approach aims to improve pain management, quality of life, and adherence to treatment in patients with chronic neck pain.', 'armGroupLabels': ['Virtual Reality-Assisted Hypnotherapy+Physiotherapy Group']}, {'name': 'Standard Physical Therapy', 'type': 'OTHER', 'description': 'Participants in the control group will undergo a standard physical therapy program focused on the cervical region, consisting of 15 sessions over 3 weeks. Each session will be supervised by physiotherapists in a clinical setting and will include traditional physical therapy techniques such as therapeutic exercises', 'armGroupLabels': ['Standard Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Tugba Sahbaz, Assoc Prof', 'role': 'CONTACT', 'email': 'piskint@gmail.com', 'phone': '+904441060'}], 'facility': 'Beykent University Faculty of Medicine, Physical Therapy Unit', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Tugba Sahbaz, Associate Professor', 'role': 'CONTACT', 'email': 'piskint@gmail.com', 'phone': '+90444 1997', 'phoneExt': '6021'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Beykent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'TUĞBA ŞAHBAZ', 'investigatorAffiliation': 'University of Beykent'}}}}