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

2. November 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Türkei (türkiye)
    • Istanbul
      • Istanbul, Istanbul, Türkei (türkiye), 34180
        • Rekrutierung
        • Istanbul Physical Medicine and Rehabilitation Training and research Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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).
Verhalten: 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.

Andere Namen:
  • VR Hypnosis
  • VR-Mediated Hypnotherapy
Sonstiges: 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.
Aktiver Komparator: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Pain Intensity (Numeric Rating Scale)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain Intensity at Follow-up (Numeric Rating Scale)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. November 2026

Studienabschluss (Geschätzt)

1. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

23. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. September 2026

Zuerst gepostet (Tatsächlich)

29. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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