Impact of Virtual Reality Distraction on Pain and Anxiety for Bedside Abdominal VAC Dressing Change - A Randomized Controlled Clinical Trial (VIRPA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of pain using a virtual reality device in addition to a standardized analgesic protocol for bedside abdominal VAC dressing change. Pain will be measured by using a visual analogue scale (VAS) for pain (0-10) in the two groups.
研究概览
简要总结
We aim to study the use of a virtual reality device (VRD) in addition to our standardized analgesic care protocol for abdominal bedside VAC dressing change and we hypothesize to decrease pain and anxiety and to increase patients' comfort by this intervention.
详细描述
Monocentric non-blinded superiority randomized controlled trial: standardized analgesic protocol + virtual reality device vs. standardized analgesic protocol alone for abdominal VAC dressing change.
The day of the procedure, each patient will receive a standardized local and systemic analgesia 30 minutes before starting the procedure. The referring surgeon will explain at this moment every step of the procedure of bedside abdominal VAC dressing change.
Baseline levels of pain and anxiety will be assessed by use of VAS (0-10) and one additional questionnaire (STAI).
Virtual reality device will be activated 15 minutes before the beginning of the procedure and will remain as long as the procedure is going on and for 15minutes after finishing the wound dressing.
15 minutes after removing the VRD and 30minutes after finishing the wound dressing the STAI questionnaire and VAS for anxiety, pain and satisfaction (0-10) will be completed by the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients requiring a bedside abdominal VAC dressing change
- •Patients above 18 years old
- •Patients able to give informed consent as documented by signature
排除标准
- •Patients under 18 years old
- •Patients with impaired cognitive status
- •Patients with known psychiatric disorders
- •Patients unable to follow the procedures of the study due to language problems
- •Not consent provided
- •Prior inclusion in the same trial (only 1 VAC dressing change per patient can be studied, the first one)
- •Pregnant patients
结局指标
主要结局
Change of pain using a virtual reality device in addition to a standardized analgesic protocol for bedside abdominal VAC dressing change. Pain will be measured by using a visual analogue scale (VAS) for pain (0-10) in the two groups.
时间窗: Baseline (pre-procedure) and immediately after the procedure
Measurement of pain using a visual analogue scale (VAS) for pain with scores range from 0 (no pain) and 10 (worst possible pain), before (baseline: pre-procedure) and immediately after bedside abdominal vacuum assisted closure (VAC) dressing change in the two groups (virtual reality device + standardized analgesic protocol and standardized analgesic protocol alone) in order to demonstrate if a virtual reality device can reduce pain when used in addition to standard care.
次要结局
- Change of anxiety using a virtual reality device along with a standardized analgesic protocol for bedside abdominal VAC dressing change. Anxiety will be measured by using, in the 2 groups, a VAS scale for anxiety along with a STAI questionnaire.(Baseline (pre-procedure) and immediately after the procedure)
- Assessment of patients satisfaction using a virtual reality device in addition to a standardized analgesic protocol for bedside abdominal VAC dressing change. Satisfaction will be measured by using a visual analogue scale (VAS) for satisfaction.(Immediately after the procedure)
研究者
Nicolas DEMARTINES
Prof.
University of Lausanne Hospitals