About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Injury duration shorter than 3 months
Significant change in analgesic treatment within the last 3 months
Visual or hearing impairment
Epilepsy
Trial design
Parallel
Treatments tested in this trial
Virtual Reality-Based Hypnotherapy
BehavioralAn immersive, audio-guided hypnotherapy session delivered through a virtual reality headset and headphones, combining visual immersion with hypnotic induction, relaxation, and pain-modulating suggestions. Each session lasts approximately 20 minutes and is administered immediately after the physiotherapy session, 5 days per week for 2 weeks (10 sessions in total), in a quiet clinical setting.
Conventional Physiotherapy
Other interventionA standard physiotherapy and rehabilitation program for spinal cord injury, applied 5 days per week for 2 weeks (10 sessions in total), identical in both study arms.
Treatment groups
Trial outcomes
Primary outcomes
Change in Pain Intensity (Numeric Rating Scale)
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.
Secondary outcomes
Pain Intensity at Follow-up (Numeric Rating Scale)
Pain intensity will be assessed using the NRS (0-10). Higher scores indicate greater pain intensity. The persistence of the effect will be evaluated at follow-up.
Neuropathic Pain (DN4 Questionnaire)
Neuropathic pain will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire, with total scores ranging from 0 to 10. Higher scores indicate a greater likelihood and burden of neuropathic pain features.
Sleep Quality (Pittsburgh Sleep Quality Index)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), with global scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Anxiety (Hospital Anxiety and Depression Scale - Anxiety Subscale)
Anxiety will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), with scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms.
Sponsors and contacts
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