Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury

NCT07846410 | Not Yet Recruiting

• 2 other identifiers: HypnoVR-SCI-20262024-BIAEK/23-28
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries (SCI); Chronic Pain; Neuropathic Pain; Sleep Disturbance; Depression

Keywords

Virtual Reality; Hypnosis; Hypnotherapy; Virtual Reality Hypnosis; Paraplegia; Tetraplegia; Rehabilitation; Physiotherapy; Quality of Life; Anxiety; Non-pharmacological Pain Management

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and end of the 2-week intervention (week 2)

Secondary Outcomes (8)

• 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)

Study Arms (2)

VR-Based Hypnotherapy + Conventional Physiotherapy

EXPERIMENTAL

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).

Behavioral: Virtual Reality-Based Hypnotherapy; Other: Conventional Physiotherapy

Conventional Physiotherapy

ACTIVE COMPARATOR

Participants will receive the same standard physiotherapy and rehabilitation program 5 days per week for 2 weeks (10 sessions), without VR-based hypnotherapy.

Other: Conventional Physiotherapy

Interventions

Virtual Reality-Based Hypnotherapy BEHAVIORAL

An 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.

Also known as: VR Hypnosis, VR-Mediated Hypnotherapy

VR-Based Hypnotherapy + Conventional Physiotherapy

Conventional Physiotherapy OTHER

A 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.

Conventional Physiotherapy; VR-Based Hypnotherapy + Conventional Physiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Istanbul, Istanbul, 34180, Turkey (Türkiye)

Location

Related Publications (3)

• Louras M, Vanhaudenhuyse A, Panda R, Rousseaux F, Carella M, Gosseries O, Bonhomme V, Faymonville ME, Bicego A. Virtual Reality Combined with Mind-Body Therapies for the Management of Pain: A Scoping Review. Int J Clin Exp Hypn. 2024 Oct-Dec;72(4):435-471. doi: 10.1080/00207144.2024.2391365. Epub 2024 Sep 30.

  PMID: 39347979 RESULT

• Jones HG, Rizzo RRN, Pulling BW, Braithwaite FA, Grant AR, McAuley JH, Jensen MP, Moseley GL, Rees A, Stanton TR. Adjunctive use of hypnosis for clinical pain: a systematic review and meta-analysis. Pain Rep. 2024 Sep 10;9(5):e1185. doi: 10.1097/PR9.0000000000001185. eCollection 2024 Oct.

  PMID: 39263007 RESULT

• Menekseoglu AK, Asik HK, Sahbaz T, Is EE. Mind over pain: VR-based hypnotherapy for chronic non-specific low back pain - a randomised controlled trial. Ir J Med Sci. 2026 Feb;195(1):177-185. doi: 10.1007/s11845-025-04158-1. Epub 2025 Nov 10.

  PMID: 41212507 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Chronic Pain; Neuralgia; Parasomnias; Depression; Paraplegia; Quadriplegia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Sleep Wake Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Paralysis

Study Officials

• Selim Sezikli, MD

  Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selim Sezikli, MD

CONTACT

+90 506 510 18 33; selimsezikli@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Physical Medicine and Rehabilitation, MD

Model Details: Participants will be randomly assigned to one of two parallel groups: VR-based hypnotherapy in addition to conventional physiotherapy, or conventional physiotherapy alone.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the main results and ending 5 years after publication.
• Access Criteria: Data will be shared with qualified researchers who provide a methodologically sound proposal, following approval by the principal investigator and a signed data use agreement.

Locations

TU (1)