Description

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.

Assessment Time Points Assessments will be conducted at baseline (T0), at the end of the 2-week intervention (T1), and 2 weeks after the end of the intervention (T2).

Safety Adverse events, including VR-related symptoms such as dizziness or nausea, will be recorded throughout the intervention period.

Statistical Analysis Data will be analyzed using SPSS. Descriptive statistics will be presented as mean, standard deviation, frequency, and percentage. Normality will be assessed using the Kolmogorov-Smirnov test. Between-group comparisons will be performed using the independent samples t-test or the Mann-Whitney U test, as appropriate. Changes over time will be analyzed using appropriate repeated-measures analyses. Statistical significance will be set at p\<0.05.