[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569754":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":52,"collaborators":26,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":58,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Beykent","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual Reality-Assisted Hypnotherapy+Physiotherapy Group","EXPERIMENTAL","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.",[13],"Device: Virtual Reality-Assisted Hypnotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Treatment Group","ACTIVE_COMPARATOR","Participants in this arm will undergo a conventional physical therapy program for 3 weeks (15 sessions) supervised by physiotherapists.",[19],"Other: Standard Physical Therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Virtual Reality-Assisted Hypnotherapy","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 low back pain.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Physical Therapy","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",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Tugba Sahbaz, Associate Professor","CONTACT","+90444 1997","6021","piskint@gmail.com",[39],{"facility":40,"status":26,"city":41,"state":26,"zip":26,"country":42,"countryCode":26,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Beykent University Faculty of Medicine, Physical Therapy Unit","Istanbul","Turkey (Türkiye)",{"type":44,"coordinates":45},"Point",[46,47],28.94966,41.01384,{"lat":47,"lon":46},[50],{"name":51,"role":34,"phone":26,"phoneExt":26,"email":37},"Tugba Sahbaz, Assoc Prof",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","TUĞBA ŞAHBAZ","Associate Professor","100569754","cost-effectiveness-analysis-of-a-virtual-reality-assisted-hypnotherapy-program-on-quality-of-life-in-patients-with-chronic-low-back-pain-a-multicenter-randomized-prospective-comparative-open-label-parallel-group-study-100569754",false,"NCT06698354","Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Low Back Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study","Inclusion Criteria:\n\n* Age between 50 and 80 years.\n* Chronic neck pain lasting for more than 3 month\n\nExclusion Criteria:\n\n* Presence of newly developed neurological deficits.\n* Existence of comorbid neurological diseases.\n* Medical history unsuitable for the use of virtual reality (VR) glasses (e.g., visual impairment, epilepsy).\n* Pregnancy.\n* Changes in medication for chronic pain management within the last three months (e.g., Pregabalin, Gabapentin, Duloxetine, etc.).","ALL","50 Years","80 Years",{"count":66,"type":67},60,"ESTIMATED","INTERVENTIONAL",[70],"NA","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 low back 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 low back pain management.",[73,74,75],"Chronic Pain","Low Back Pain","Chronic Low Back Pain (CLBP)",[77,78],"hypnotherapy","virtual reality","NOT_YET_RECRUITING","2024-11-18",{"date":82,"type":83},"2024-11-21","ACTUAL",{"date":85,"type":67},"2024-12-02",{"date":87,"type":67},"2025-07-01",{"name":5,"class":6},1]