Developing a Virtual Reality (VR)-Based Prototype for Perioperative Care - a Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Pre-operative anxiety
研究概览
简要总结
Preoperative anxiety and acute post-operative pain are common and have been associated with the development of chronic post-surgical pain and longer hospitalisation. Pharmacological interventions to combat anxiety and pain come with their attendant adverse effects. Therefore, non-pharmacological strategies- Virtual Reality (VR) has gained popularity to improve overall the perioperative experience for patients.
Our overall aim was to develop and evaluate the use of a VR-based prototype to reduce pre-operative anxiety and post-operative acute pain intensity in our local patient population. Our primary objective was to develop a customized VR mindfulness application incorporating locally relevant scenarios and evaluate its feasibility, acceptability and preliminary associations with changes in perioperative anxiety and pain. Our secondary objectives included evaluating patient satisfaction and preferences for different VR modules.
详细描述
This will be a multi-center, prospective cohort study to be conducted in Changi General Hospital (CGH) and KKH, in collaboration with industry partner, Vue Networks. The patients will provide written informed consent for the study.
Phase 1: To facilitate the development of VR application that is suitable for perioperative care management, a survey will be conducted in 100 subjects (CGH: n=50; KKH: n=50) to gather patient preference and feedback with needs analysis.
The VR application development needs analysis would focus on:
i) instructional module on surgical journey; and ii) mindfulness module with inputs from perspectives of clinical health psychology iii) local relaxation scenarios (e.g. village, botanic gardens, Changi beach, Gardens by the bay); iv) feedback on hardware, i.e., VR headset usability.
Phase 2: The testing of the developed VR application will be performed in 60 subjects (CGH: n=30; KKH: n=30).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 21 years old and above and undergoing scheduled surgery;
- •American Society of Anesthesiologist physical status I to III, with no visual or hearing impairment; and
- •Understands English or Chinese.
排除标准
- •Comorbidities affecting usage of virtual reality e.g., giddiness, motion sickness, claustrophobia, stroke, seizure, dementia, transmissible diseases, severe facial eczema; and
- •Unable to understand the administered questionnaires.
研究组 & 干预措施
Phase 1 - Patient feedback and needs analysis
To facilitate the development of virtual reality application that is suitable for perioperative care management, a survey will be conducted in 100 subjects to gather patient preference and feedback with needs analysis.
Phase 2 - Evaluation of prototype efficacy
Comparison of pre-operative anxiety and post-operative pain in 60 patients before and after intervention using the developed virtual reality application.
干预措施: Virtual reality (Device)
结局指标
主要结局
Pre-operative anxiety
时间窗: up to 1hour
Anxiety score - VAS-A (0 to 10; 0-best outcome, 10-worst outcome)
次要结局
- Post-operative pain(up to 1hour)
- User satisfaction(up to 1hour)
研究者
Lydia Li Weiling
Consultant, Department of Anaesthesia and Surgical Intensive Care
Changi General Hospital