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
| Registry | NCT07846410, acronym HypnoVR-SCI |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other gov) |
| Conditions | Spinal Cord Injuries (SCI), Chronic Pain, Neuropathic Pain, Sleep Disturbance, Depression |
| Interventions | Virtual Reality-Based Hypnotherapy, Conventional Physiotherapy (Behavioral, other) |
| Dates | start 2026-10-01 (estimated), primary completion 2026-11-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-09-29, last updated 2026-09-29 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Spinal Cord Injuries (SCI) All trials for Chronic Pain All trials of Virtual Reality-Based Hypnotherapy All trials of Conventional Physiotherapy
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| VR-Based Hypnotherapy + Conventional Physiotherapy | Experimental | Behavioral: Virtual Reality-Based Hypnotherapy; Other: 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). |
| Conventional Physiotherapy | Active comparator | 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. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * 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 Exclusion Criteria: * Injury duration shorter than 3 months * Significant change in analgesic treatment within the last 3 months * Visual or hearing impairment * Epilepsy * Severe psychiatric illness (psychosis, severe major depression, or bipolar disorder in the acute phase) * Pregnancy
| Facility | City | Country | Status |
|---|---|---|---|
| Istanbul Physical Medicine and Rehabilitation Training and research Hospital | Istanbul, Istanbul | Turkey (Türkiye) |