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

2 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Turcja (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turcja (Türkiye), 34180
        • Rekrutacyjny
        • Istanbul Physical Medicine and Rehabilitation Training and research Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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).
Behawioralne: 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.

Inne nazwy:
  • VR Hypnosis
  • VR-Mediated Hypnotherapy
Inny: 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.
Aktywny 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.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Pain Intensity (Numeric Rating Scale)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Pain Intensity at Follow-up (Numeric Rating Scale)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 października 2026

Zakończenie podstawowe (Szacowany)

1 listopada 2026

Ukończenie studiów (Szacowany)

1 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

23 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 września 2026

Pierwszy wysłany (Rzeczywisty)

29 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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