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
- Conditions
- Chronic Neck PainNeck Pain
- Registration Number
- NCT06697795
- Lead Sponsor
- University of Beykent
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age between 50 and 80 years.
- Chronic neck pain lasting for more than 3 months.
- History of spinal surgery.
- Beck Depression Inventory (BDI) score >16.
- Presence of neurological deficits or concurrent neurological diseases.
- Medical conditions incompatible with the use of VR headsets (e.g., vision problems, epilepsy).
- Pregnancy.
- Recent changes in medication for chronic pain within the past 3 months (e.g.,- Pregabalin, Gabapentin, Duloxetine).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Pain Intensity Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups. 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.
- Secondary Outcome Measures
Name Time Method Change in Functional Status Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups. 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.
Change in Quality of Life Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups. Quality of life will be measured using the Short Form-12 (SF-12) questionnaire.
Reduction in Analgesic Use Baseline and weekly throughout the 3-month follow-up period. The number of days per week participants use nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen for pain management will be recorded.
Change in Anxiety and Depression Levels Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups. Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS).
Reduction in Healthcare Utilization Assessed retrospectively at baseline and at the 3-month follow-up. 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.
Trial Locations
- Locations (1)
Beykent University Faculty of Medicine, Physical Therapy Unit
🇹🇷Istanbul, Turkey