Feasibility of a Multimodal Virtual Reality Intervention to Reduce Preoperative Anxiety in Cancer Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Engagement
研究概览
简要总结
The goal of this study is to assess the feasibility of an expanded virtual reality (VR) intervention designed to help prepare patients for cancer surgery. This study will: (1) assess the investigator's ability to recruit, retain, and engage participants, (2) evaluate how acceptable participants find the intervention through their feedback on its individual components. The investigators will also explore whether baseline anxiety levels or psychiatric history predict responses to the intervention, as well as look for any changes in perioperative anxiety and monitoring for any adverse effects associated with the intervention. This study will also investigate engagement of providing participants with a first-person VR session recordings to determine utility and whether post-session access is perceived as beneficial. Finally, preliminary pilot outcomes will examine whether increased engagement in the VR results in reductions in anxiety on the day of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- •Patients will be deemed eligible for inclusion if they: (a) are 18 years of age or older; (b) are able to speak and read English; (c) have received a cancer diagnosis; and (d) are scheduled, or in the process of being scheduled to undergo oncological surgery under general anesthesia at the Health Sciences Centre Winnipeg. Patients will be deemed ineligible if they are unable to provide informed consent (e.g., due to cognitive impairment) or if they have any visual, auditory and/or motor impairments that would preclude effective participation in the Virtual Reality intervention.
排除标准
- 未提供
研究组 & 干预措施
Daily Viewing Group
Participants assigned to this group will be instructed to review the standardized VR intervention recording daily, following their in-person session and continuing up to their scheduled surgery date.
干预措施: Virtual Reality (Device)
Self-directed group
Participants assigned to this group will be instructed to review the standardized VR intervention recording as little or as much as they would like, following their in-person session and continuing up to their scheduled surgery date.
干预措施: Virtual Reality (Device)
结局指标
主要结局
Engagement
时间窗: Day 0 post-intervention
Length of time in minutes participants spent engaging with the virtual reality and each of its components during the in-person session
Acceptability
时间窗: Day 0 post-intervention
The Theoretical Framework of Acceptability Questionnaire (TFAQ score \> 3 indicates acceptability). Range 1-5 on seven items.
次要结局
- Anxiety(Baseline)
- Depression(Baseline)
- Pre-Operative Anxiety(Baseline and re-administered pre-operatively on the day of surgery)
- Pre-Operative Anxiety(Baseline)
- Pre-Operative Anxiety(Baseline and re-administered pre-operatively on the day of surgery.)
- Pre-Operative Distress(Baseline and re-administered pre-operatively on the day of surgery)
- Cybersickness(Day 0 post-intervention)
- Presence(Day 0 post-intervention)
- Perceived Usability of Device(Day 0 post-intervention)
- Engagement & Adherence - Standardized Video(Day 1 up to Day 14)
研究者
Renée El-Gabalawy
Associate Professor & Clinical Psychologist
University of Manitoba