A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Procedural Anxiety and Procedural Pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to the nature of the intervention, blinding of participants and investigators is not feasible, as the use of the immersive virtual reality headset is directly visible during the procedure.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Virtual Reality Group
Participants receive immersive virtual reality during the interventional radiology procedure in addition to standard care.
干预措施: Immersive Virtual Reality (Device)
Control Group
Participants receive standard care during the interventional radiology procedure without immersive virtual reality.
结局指标
主要结局
Change in Procedural Anxiety and Procedural Pain
时间窗: 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.
次要结局
未报告次要终点