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Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury (HypnoVR-SCI)

2 novembre 2026 mis à jour par: Selim Sezikli, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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:

  • 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Turquie (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turquie (Türkiye), 34180
        • Recrutement
        • Istanbul Physical Medicine and Rehabilitation Training and research Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: VR-Based Hypnotherapy + 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).
Comportemental: Virtual Reality-Based 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.

Autres noms:
  • VR Hypnosis
  • VR-Mediated Hypnotherapy
Autre: Conventional Physiotherapy

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.
Comparateur actif: 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.
Autre: Conventional Physiotherapy

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Pain Intensity (Numeric Rating Scale)
Délai: Baseline and end of the 2-week intervention (week 2)

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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pain Intensity at Follow-up (Numeric Rating Scale)
Délai: Baseline and 2 weeks after the end of the intervention (week 4)

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.
Baseline and 2 weeks after the end of the intervention (week 4)
Neuropathic Pain (DN4 Questionnaire)
Délai: Baseline, week 2 (end of intervention), and week 4 (follow-up)

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.
Baseline, week 2 (end of intervention), and week 4 (follow-up)
Sleep Quality (Pittsburgh Sleep Quality Index)
Délai: Baseline, week 2 (end of intervention), and week 4 (follow-up)

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.
Baseline, week 2 (end of intervention), and week 4 (follow-up)
Anxiety (Hospital Anxiety and Depression Scale - Anxiety Subscale)
Délai: Baseline, week 2 (end of intervention), and week 4 (follow-up)

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.
Baseline, week 2 (end of intervention), and week 4 (follow-up)
Depression (Hospital Anxiety and Depression Scale - Depression Subscale)
Délai: Baseline, week 2 (end of intervention), and week 4 (follow-up)

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.
Baseline, week 2 (end of intervention), and week 4 (follow-up)
Spasticity (Modified Ashworth Scale)
Délai: Baseline, week 2 (end of intervention), and week 4 (follow-up)

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.
Baseline, week 2 (end of intervention), and week 4 (follow-up)
Health-Related Quality of Life (EQ-5D-5L)
Délai: Baseline, week 2 (end of intervention), and week 4 (follow-up)

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.
Baseline, week 2 (end of intervention), and week 4 (follow-up)
System Usability (System Usability Scale)
Délai: End of the 2-week intervention (week 2)

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.
End of the 2-week intervention (week 2)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Les enquêteurs

  • Chercheur principal: Selim Sezikli, MD, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 octobre 2026

Achèvement primaire (Estimé)

1 novembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

23 septembre 2026

Première soumission répondant aux critères de contrôle qualité

23 septembre 2026

Première publication (Réel)

29 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HypnoVR-SCI-2026
  • 2024-BIAEK/23-28 (Autre identifiant: Biruni University Scientific Research Ethics Committee)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data underlying the results reported in the publication will be shared upon reasonable request to the principal investigator.

Délai de partage IPD

Beginning 6 months after publication of the main results and ending 5 years after publication.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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