Feasibility of a Virtual Reality Intervention for Patients Undergoing Urological Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Inclusion criteria and demographic and surgery-related differences
研究概览
简要总结
It is standard practice for most cystoscopies and vasectomies in an office or outpatient setting to be performed under local anesthesia while the patient is awake and conscious. However, given the conscious nature of these procedures, patients may experience anxiety-inducing stressors that they otherwise would not under general anesthesia. Stressors such as hearing surgical terminology, technical discussion, and injection of local anesthetic have been previously documented as sources of perioperative anxiety and pain in awake surgeries.
The current study will examine the feasibility and pilot outcomes of Virtual Reality (VR) guided meditation therapy during cystoscopies and vasectomies. Feasibility will be examined through: (1) recruitment capability and resulting sample characteristics, (2) data collection procedures (including randomization) and outcome measures, and (3) participant acceptability and suitability of the VR intervention during the procedures. The investigators will also evaluate pilot outcomes of the VR intervention on pain, anxiety, and overall satisfaction with the procedure. Results of this study will inform the development of a large-scale randomized clinical trial (RCT) to evaluate the efficacy of this intervention.
Participants will be asked to complete questionnaires before and after their procedure and will be asked for a verbal measure of their pain and anxiety during the procedure.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •can speak and read English
- •have an indication for a cystoscopy or elected for a vasectomy
- •are scheduled to undergo their respective procedure under local anesthesia at the Men's Health Clinic between the dates of May-November 2024.
排除标准
- •those who are not competent to provide informed consent (e.g., due to cognitive impairment)
- •those who are unable to participate in a VR intervention (e.g., due to visual or auditory impairment)
结局指标
主要结局
Inclusion criteria and demographic and surgery-related differences
时间窗: through study completion, up to 1 year
Proportion of individuals who meet inclusion criteria and any demographic and surgery-related differences in potentially eligible participants
Acceptability through elevate scores on the Virtual Reality Impression Scale
时间窗: Immediate post-operative
Acceptability of the VR program during urological procedures (0 thru 100, 100=positive impressions)
Impressions of the VR based on open-ended responses on the Virtual Reality Impression Scale
时间窗: Immediate post-operative
Negative and positive impressions of the VR intervention (open ended/qualitative)
Recruitment rate
时间窗: through study completion, up to 1 year
Proportion of individuals who consent to participation and the number of recruited participants per week
Retention of participants in the study
时间窗: Immediate post-operative
Proportion of individuals who tolerate the intervention and complete the study
次要结局
- Subjective assessment of time spent in VR vs. actual time in VR(Evaluated immediate post-operative)
- Scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (and adapted Anxiety Thermometer)(Pre-operative, acute post-operative (immediately following surgery))
- Visual Analogue Scale anxiety severity(Peri-operative (mid-way through procedure))
- PROMIS Pain Intensity Scale total score(Acute post-operative (immediately following surgery))
- Visual Analogue Scale pain severity(Peri-operative (mid-way through procedure))
- i-Group Presence Questionnaire (IPQ) score(Acute post-operative (immediately following surgery))
- State Trait Anxiety Inventory (STAI) elevated scores(Pre-operative, acute post-operative (immediately following surgery))
- Satisfaction With Surgery score(Acute post-operative (immediately following surgery))
- Selection of VR experience(Pre-operative)
研究者
Renée El-Gabalawy
Associate Professor
University of Manitoba