Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury (HypnoVR-SCI)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Selim Sezikli, MD
- 電話番号：+90 506 510 18 33
- メール：selimsezikli@hotmail.com
研究場所
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Istanbul
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Istanbul、Istanbul、トルコ（Türkiye）、34180
- 募集
- Istanbul Physical Medicine and Rehabilitation Training and research Hospital
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コンタクト：
- Selim Sezikli, MD
- 電話番号：+905065101833
- メール：selimsezikli@hotmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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). |
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.
他の名前：
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. |
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アクティブコンパレータ：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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Pain Intensity (Numeric Rating Scale)
時間枠：Baseline and end of the 2-week intervention (week 2)
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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)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Intensity at Follow-up (Numeric Rating Scale)
時間枠：Baseline and 2 weeks after the end of the intervention (week 4)
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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)
|
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Neuropathic Pain (DN4 Questionnaire)
時間枠：Baseline, week 2 (end of intervention), and week 4 (follow-up)
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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)
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Sleep Quality (Pittsburgh Sleep Quality Index)
時間枠：Baseline, week 2 (end of intervention), and week 4 (follow-up)
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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)
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Anxiety (Hospital Anxiety and Depression Scale - Anxiety Subscale)
時間枠：Baseline, week 2 (end of intervention), and week 4 (follow-up)
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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)
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Depression (Hospital Anxiety and Depression Scale - Depression Subscale)
時間枠：Baseline, week 2 (end of intervention), and week 4 (follow-up)
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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)
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Spasticity (Modified Ashworth Scale)
時間枠：Baseline, week 2 (end of intervention), and week 4 (follow-up)
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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)
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Health-Related Quality of Life (EQ-5D-5L)
時間枠：Baseline, week 2 (end of intervention), and week 4 (follow-up)
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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)
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System Usability (System Usability Scale)
時間枠：End of the 2-week intervention (week 2)
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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)
|
協力者と研究者
捜査官
- 主任研究者：Selim Sezikli, MD、Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HypnoVR-SCI-2026
- 2024-BIAEK/23-28 (その他の識別子：Biruni University Scientific Research Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
De-identified individual participant data underlying the results reported in the publication will be shared upon reasonable request to the principal investigator.
IPD 共有時間枠
Beginning 6 months after publication of the main results and ending 5 years after publication.
IPD 共有アクセス基準
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.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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