Preoperative Virtual Reality for Cancer Surgery Patients: A Feasibility and Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Self-reported impressions of the virtual reality operating room simulation
研究概览
简要总结
This study will pilot test and explore the feasibility of a virtual reality simulation of the operating room environment to reduce anxiety/distress in cancer surgery patients. Study objectives are to evaluate recruitment and data collection procedures, outcome measures, participant feedback on the virtual reality operating room intervention, and the inclusion of a treatment as usual group, and effects of the intervention on symptoms of anxiety/distress. Results of this study will inform the design of an upcoming larger-scale RCT to assess the efficacy of this intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Over the age of 18
- •Can speak and read English
- •Has a cancer diagnosis
- •Scheduled/being scheduled to undergo cancer surgery under general anesthesia at the Health Sciences Centre (Winnipeg, MB)
排除标准
- •Those who do not meet any inclusion criteria
- •Those who are not competent to provide informed consent (e.g., due to cognitive impairment)
- •Those who are unable to participate in a virtual reality intervention (e.g., due to visual/auditory impairment)
结局指标
主要结局
Self-reported impressions of the virtual reality operating room simulation
时间窗: 5 days
Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention
次要结局
- iGroup Presence Questionnaire(Immediately after the intervention)
- Preoperative Intrusive Thoughts Inventory (PITI)(Baseline and up to 2 weeks after baseline on day of scheduled surgery)
- NCCN Distress Thermometer(Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days)
- NCCN Anxiety Thermometer(Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days)
- Amsterdam Preoperative Anxiety Information Scale (APAIS)(Baseline and up to 2 weeks after baseline on day of scheduled surgery)
研究者
Jordana Sommer
Principal Investigator
University of Manitoba