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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 80 years.
- •Chronic neck pain lasting for more than 3 month
排除标准
- •Presence of newly developed neurological deficits.
- •Existence of comorbid neurological diseases.
- •Medical history unsuitable for the use of virtual reality (VR) glasses (e.g., visual impairment, epilepsy).
- •Pregnancy.
- •Changes in medication for chronic pain management within the last three months (e.g., Pregabalin, Gabapentin, Duloxetine, etc.).
结局指标
主要结局
Change in Pain Intensity
时间窗: 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.
次要结局
- Change in Functional Status(Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.)
- Change in Quality of Life(Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.)
- Reduction in Analgesic Use(Baseline and weekly throughout the 3-month follow-up period.)
- Change in Anxiety and Depression Levels(Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.)
- Reduction in Healthcare Utilization(Assessed retrospectively at baseline and at the 3-month follow-up.)
研究者
TUĞBA ŞAHBAZ
Associate Professor
University of Beykent