A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology. (HYPNO-VR)
Patients undergoing interventional radiology procedures frequently experience significant anxiety and procedural pain despite standard care. Virtual reality (VR) has emerged as a promising non-pharmacological tool for anxiety and pain reduction in various medical settings.
The HYPNO-VR study is a prospective randomized controlled trial designed to evaluate the effect of immersive virtual reality during interventional radiology procedures. Participants will be randomized in a 1:1 ratio to either a virtual reality group or a standard care control group.
The primary objective is to assess the impact of VR on procedural anxiety and pain using validated anxiety questionnaires (State-Trait Anxiety Inventory, STAI) and a numerical pain rating scale.
Secondary and exploratory objectives include assessment of patient satisfaction, operator experience, procedural duration, analgesic use, and feasibility of VR integration in interventional radiology practice.
調査の概要
詳細な説明
Interventional radiology procedures are frequently associated with significant procedural anxiety and pain, which may negatively affect patient experience, cooperation during the procedure, and overall procedural conditions. Although pharmacological analgesia and anxiolysis are commonly used, non-pharmacological approaches aimed at improving patient comfort are increasingly being explored.
Immersive virtual reality (VR) has demonstrated promising effects on anxiety and pain reduction in several medical and surgical settings. By providing immersive audiovisual stimulation and distraction, VR may reduce the emotional and sensory perception associated with stressful medical procedures. However, data regarding its use in interventional radiology remain limited.
The HYPNO-VR study is a prospective randomized controlled monocentric study evaluating the impact of immersive virtual reality during interventional radiology procedures performed under local anesthesia.
Eligible adult patients undergoing an interventional radiology procedure will be randomized in a 1:1 ratio to either :
- a virtual reality group receiving immersive VR during the procedure in addition to standard care ;
- or a control group receiving standard care alone.
The primary objective is to evaluate the effect of VR on procedural anxiety and pain. Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-Y), including trait anxiety assessment before the procedure and state anxiety assessment immediately before and after the procedure. Procedural pain will be evaluated using a numerical rating scale.
Secondary and exploratory objectives include evaluation of patient satisfaction, operator experience, procedural duration, analgesic use during the procedure, and feasibility of VR integration into routine interventional radiology practice.
The study aims to assess whether immersive VR may represent a simple, feasible, and effective complementary tool to improve patient experience during interventional radiology procedures.
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：Lise Laclautre
- 電話番号：0473754963
- メール：promo_interne_drci@chu-clermontferrand.fr
研究場所
-
-
-
Clermont-Ferrand、フランス
- CHU clermont-ferrand
-
主任研究者：
- Pascal Chabrot
-
コンタクト：
- Lise Laclautre
- 電話番号：0473754963
- メール：promo_interne_drci@chu-clermontferrand.fr
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria :
- Age ≥18 years.
- Scheduled to undergo an interventional radiology procedure performed under local anesthesia without sedation.
- Affiliation to a health insurance system.
- Received complete information about the study and provided written informed consent.
- Ability to understand the study information and complete the questionnaires.
Exclusion Criteria :
- Refusal to participate or withdrawal of consent.
- Patients under legal protection preventing valid informed consent according to regulatory requirements.
- Inability to understand study-related information or to use the virtual reality device due to severe visual, auditory, or cognitive impairment, as clinically assessed by the investigator.
- History of photosensitive epilepsy or uncontrolled epilepsy, constituting a contraindication to virtual reality use.
- Known contraindication to virtual reality use (history of severe cybersickness).
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Virtual Reality Group
Participants receive immersive virtual reality during the interventional radiology procedure in addition to standard care.
|
Use of an immersive virtual reality headset during interventional radiology procedures performed under local anesthesia in order to reduce procedural anxiety and pain.
他の名前：
|
|
介入なし：Control Group
Participants receive standard care during the interventional radiology procedure without immersive virtual reality.
|
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 |
|---|---|---|
|
Change in Procedural Anxiety and Procedural Pain
時間枠：From immediately before the procedure to immediately after the procedure
|
Evaluation of procedural anxiety using the State-Trait Anxiety Inventory State scale (STAI-Y1) before and after the procedure.
STAI-Y1 scores range from 20 to 80, with higher scores indicating greater anxiety.
Procedural pain is assessed immediately after the procedure using a numerical rating scale ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain.
|
From immediately before the procedure to immediately after the procedure
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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 |
|---|---|---|
|
Patient Satisfaction
時間枠：Immediately after the procedure
|
Patient satisfaction assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
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Immediately after the procedure
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Operator Experience
時間枠：Immediately after the procedure
|
Operator experience regarding the procedure assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
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Immediately after the procedure
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Procedure Duration
時間枠：During the procedure
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Duration of the interventional radiology procedure, measured in minutes from the beginning to the end of the intervention.
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During the procedure
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Analgesic Use During the Procedure
時間枠：During the procedure
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Use and type of analgesic medications administered during the procedure.
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During the procedure
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Feasibility of Immersive Virtual Reality Use
時間枠：During and immediately after the procedure
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Feasibility of immersive virtual reality use during interventional radiology procedures, assessed descriptively through device-related incidents and interruptions of device use.
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During and immediately after the procedure
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協力者と研究者
捜査官
- 主任研究者：Pascal Chabrot、University Hospital, Clermont-Ferrand
研究記録日
主要日程の研究
研究開始 (推定)
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
その他の研究ID番号
- RBHP 2025 CHABROT
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