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
- 1
- 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)
研究组 & 干预措施
Intervention group
Participants will be exposed to a virtual reality simulation of the operating room environment for a minimum of ten minutes.
干预措施: Virtual reality operating room simulation (Device)
Treatment as usual group
Participants will receive standard of care with no additional intervention aside from information received at their surgical oncology appointment and optional preoperative education classes (available to all patients).
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
Self-reported impressions of the virtual reality operating room simulation
时间窗: Baseline
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