The Effect of Virtual Reality-Based Hypnotherapy on Pain, Sleep, Depression, and Quality of Life in Patients With Spinal Cord Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity (Numeric Rating Scale)
研究概览
简要总结
The goal of this clinical trial is to learn whether virtual reality (VR)-based hypnotherapy, added to conventional physiotherapy, improves pain, sleep, mood, and quality of life in adults with chronic spinal cord injury.
The main questions it aims to answer are:
- Does VR-based hypnotherapy added to physiotherapy reduce pain intensity more than physiotherapy alone?
- Does it improve neuropathic pain, sleep quality, anxiety and depression, spasticity, and quality of life?
Researchers will compare participants who receive VR-based hypnotherapy in addition to physiotherapy with participants who receive physiotherapy alone.
Participants will:
- Receive a standard physiotherapy and rehabilitation program 5 days a week for 2 weeks (10 sessions).
- If assigned to the VR group, also receive an approximately 20-minute VR-based hypnotherapy session after each physiotherapy session, using a VR headset and headphones.
- Complete assessments at the start of the study, at the end of the 2-week treatment period, and 2 weeks after treatment ends.
详细描述
Background and Rationale Pain is one of the most common and disabling consequences of spinal cord injury (SCI) and negatively affects functional status, sleep, emotional well-being, and quality of life. Pharmacological treatments are often insufficient or limited by side effects, and there is a need for safe, non-invasive, non-pharmacological adjunct therapies. Virtual reality (VR) may reduce pain through attentional redirection and immersion, while hypnotherapy may modulate pain perception through relaxation and cognitive reprocessing of pain. VR-based hypnotherapy combines these mechanisms and has shown short-term benefits in chronic musculoskeletal pain; however, its effects in individuals with SCI have not been investigated in a randomized controlled trial.
Study Design This is a prospective, randomized controlled, parallel-group, single-center, single-blind trial. A total of 40 patients with SCI will be enrolled. Participants will be allocated to two groups by computer-generated randomization: (1) intervention group, receiving VR-based hypnotherapy in addition to conventional physiotherapy; (2) control group, receiving conventional physiotherapy alone.
Interventions Both groups will receive a standard physiotherapy and rehabilitation program, 5 days per week for 2 weeks (10 sessions in total). Participants in the intervention group will additionally receive an approximately 20-minute VR-based hypnotherapy session following each physiotherapy session. Sessions will be delivered in a quiet clinical setting using a VR headset and headphones. The number of sessions completed and session duration will be recorded for each participant.
Baseline Data Sociodemographic characteristics, injury etiology and duration, comorbidities, complications, and current analgesic and antispastic medication use will be recorded. Neurological level and severity of injury will be classified according to the American Spinal Injury Association (ASIA) Impairment Scale.
Blinding Outcome assessments will be performed by a trained assessor blinded to group allocation. Due to the nature of the intervention, participants and therapists cannot be blinded.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessments will be performed by a trained assessor blinded to group allocation. Participants and therapists cannot be blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Diagnosis of spinal cord injury
- •Injury duration longer than 3 months
- •Mini-Mental State Examination (MMSE) score above 24
- •Willingness to participate and provision of written informed consent
排除标准
- •Injury duration shorter than 3 months
- •Significant change in analgesic treatment within the last 3 months
- •Visual or hearing impairment
- •Severe psychiatric illness (psychosis, severe major depression, or bipolar disorder in the acute phase)
- •Pregnancy
研究组 & 干预措施
VR-Based Hypnotherapy + Conventional Physiotherapy
Participants will receive a standard physiotherapy and rehabilitation program 5 days per week for 2 weeks (10 sessions). In addition, following each physiotherapy session, they will receive an approximately 20-minute virtual reality (VR)-based hypnotherapy session delivered in a quiet clinical setting via a VR headset and headphones (10 VR sessions in total).
干预措施: Virtual Reality-Based Hypnotherapy (Behavioral)
VR-Based Hypnotherapy + Conventional Physiotherapy
Participants will receive a standard physiotherapy and rehabilitation program 5 days per week for 2 weeks (10 sessions). In addition, following each physiotherapy session, they will receive an approximately 20-minute virtual reality (VR)-based hypnotherapy session delivered in a quiet clinical setting via a VR headset and headphones (10 VR sessions in total).
干预措施: Conventional Physiotherapy (Other)
Conventional Physiotherapy
Participants will receive the same standard physiotherapy and rehabilitation program 5 days per week for 2 weeks (10 sessions), without VR-based hypnotherapy.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Change in Pain Intensity (Numeric Rating Scale)
时间窗: Baseline and end of the 2-week intervention (week 2)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. The change from baseline to the end of the intervention will be compared between groups.
次要结局
- Pain Intensity at Follow-up (Numeric Rating Scale)(Baseline and 2 weeks after the end of the intervention (week 4))
- Neuropathic Pain (DN4 Questionnaire)(Baseline, week 2 (end of intervention), and week 4 (follow-up))
- Sleep Quality (Pittsburgh Sleep Quality Index)(Baseline, week 2 (end of intervention), and week 4 (follow-up))
- Anxiety (Hospital Anxiety and Depression Scale - Anxiety Subscale)(Baseline, week 2 (end of intervention), and week 4 (follow-up))
- Depression (Hospital Anxiety and Depression Scale - Depression Subscale)(Baseline, week 2 (end of intervention), and week 4 (follow-up))
- Spasticity (Modified Ashworth Scale)(Baseline, week 2 (end of intervention), and week 4 (follow-up))
- Health-Related Quality of Life (EQ-5D-5L)(Baseline, week 2 (end of intervention), and week 4 (follow-up))
- System Usability (System Usability Scale)(End of the 2-week intervention (week 2))
研究者
Selim Sezikli
Specialist in Physical Medicine and Rehabilitation, MD
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
