AzTrials
AzTrials

Spinal Cord Injuries (SCI)HypnoVR-SCINCT07846410

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

A study testing Virtual Reality-Based Hypnotherapy and Conventional Physiotherapy in people with Spinal Cord Injuries (SCI) and Chronic Pain, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Virtual Reality-Based Hypnotherapy and Conventional Physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul Physical Medicine and Rehabilitation Training and research Hospital

    Istanbul, Istanbul, 34180

    Selim Sezikli, MD, +905065101833, selimsezikli@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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

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:

Read more
  • 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.
Read the detailed 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.

Being tested
Virtual Reality-Based Hypnotherapy, Conventional Physiotherapy
Keywords
Virtual Reality, Hypnosis, Hypnotherapy, Virtual Reality Hypnosis, Paraplegia, Tetraplegia, Rehabilitation, Physiotherapy, Quality of Life, Anxiety, Non-pharmacological Pain Management
Medical subject headings
Spinal Cord Injuries, Chronic Pain, Neuralgia, Parasomnias, Depression, Paraplegia, Quadriplegia, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality-Based HypnotherapyBehavioural

    Also called VR Hypnosis, VR-Mediated Hypnotherapy

    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.

  • Conventional PhysiotherapyOther

    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.

Study groups in NCT07846410
Study groupRoleWhat they receive
VR-Based Hypnotherapy + Conventional PhysiotherapyExperimentalParticipants 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).
Receives: Behavioral: Virtual Reality-Based Hypnotherapy; Other: Conventional Physiotherapy
Conventional PhysiotherapyActive comparatorParticipants will receive the same standard physiotherapy and rehabilitation program 5 days per week for 2 weeks (10 sessions), without VR-based hypnotherapy.
Receives: Other: Conventional Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)
  1. 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.

    Measured: Baseline and 2 weeks after the end of the intervention (week 4)

  2. 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.

    Measured: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  3. 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.

    Measured: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  4. 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.

    Measured: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  5. Depression (Hospital Anxiety and Depression Scale - Depression Subscale)

    Depression will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D), with scores ranging from 0 to 21. Higher scores indicate more severe depressive symptoms.

    Measured: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  6. Spasticity (Modified Ashworth Scale)

    Spasticity will be assessed using the Modified Ashworth Scale (MAS), graded as 0, 1, 1+, 2, 3, and 4. Higher grades indicate greater muscle tone.

    Measured: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  7. Health-Related Quality of Life (EQ-5D-5L)

    Health-related quality of life will be assessed using the EQ-5D-5L, including the five-dimension index score and the EQ Visual Analogue Scale (EQ-VAS, 0-100). Higher index and EQ-VAS scores indicate better health status.

    Measured: Baseline, week 2 (end of intervention), and week 4 (follow-up)

  8. System Usability (System Usability Scale)

    Usability of the VR-based hypnotherapy system will be assessed in the intervention group only using the System Usability Scale (SUS), with scores ranging from 0 to 100. Higher scores indicate better usability.

    Measured: End of the 2-week intervention (week 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2026
  2. Study start1 Oct 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of two parallel groups: VR-based hypnotherapy in addition to conventional physiotherapy, or conventional physiotherapy alone.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07846410
Sponsor's protocol ID
HypnoVR-SCI-2026
Other IDs
2024-BIAEK/23-28
Acronym
HypnoVR-SCI
Status last verified
Nov 2026
First submitted
23 Sep 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in the publication will be shared upon reasonable request to the principal investigator.

Publications

  • 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.

    PubMed 39347979
  • 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.

    PubMed 39263007
  • 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.

    PubMed 41212507

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality-Based Hypnotherapy and Conventional Physiotherapy in people with Spinal Cord Injuries (SCI) and Chronic Pain, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Selim Sezikli, MD (+90 506 510 18 33, selimsezikli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity (Numeric Rating Scale) (time frame: Baseline and end of the 2-week intervention (week 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07846410, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in