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

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.

NCT Number	NCT06698354
Lead Sponsor	University of Beykent
Conditions	Chronic Pain, Low Back Pain, Chronic Low Back Pain (CLBP)
Enrollment	60 participants
Start Date	2024-12-02
Primary Completion	2025-04-01 (estimated)
Study Completion	2025-07-01 (estimated)
Updated on ClinicalTrials.gov	2024-11-21