A Perioperative Virtual Reality Intervention for Pain and Anxiety Management During Vasectomies: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (NRS) for Pain Severity
研究概览
简要总结
The goal of this clinical trial is to learn if a virtual reality (VR) program (TRIPP) can reduce pain, anxiety, and distress in adult men (aged 18+) undergoing a vasectomy under local anesthesia. The main questions it aims to answer are:
- Does using VR during a vasectomy lower patients' pain during the procedure compared to standard care?
- Does VR reduce anxiety and distress compared to standard care?
- Are patients more satisfied with their experience when using VR compared to standard care?
Researchers will compare two groups:
- VR group: Patients will use a VR headset with a guided meditation program (TRIPP) during their vasectomy.
- Control group: Patients will receive standard care (no VR).
Participants will:
- Be randomly assigned to either the VR group or control group.
- Complete brief questionnaires before, during, and after the procedure (about 15-20 minutes each time).
- (VR group only) Use a VR headset during the procedure and provide optional feedback about the experience.
Why is this important? Vasectomies are typically done with local anesthesia (pain relief), but many patients still feel anxiety or discomfort. VR may help distract and relax patients, improving their experience. This study will help health professionals understand if VR could be a useful option for future patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 elected for a vasectomy.
- •Are scheduled to undergo their vasectomy under local anesthesia at the Men's Health Clinic
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).
研究组 & 干预措施
Virtual Reality Vasectomy
This group of participants will receive undergo their vasectomy with the virtual reality intervention alongside the local anesthetic.
干预措施: Virtual reality (VR) guided meditation therapy (Device)
Standard Vasectomy
Vasectomy treatment as usual, with local anesthetic, without virtual reality.
干预措施: Treatment as usual (Other)
结局指标
主要结局
Numeric Rating Scale (NRS) for Pain Severity
时间窗: Perioperatively (midway through procedure) and immediately following the procedure.
During and immediately following the procedure, patients will be momentarily interrupted to give a brief NRS verbal response question measure of their level of acute pain, this is on a scale of 0-10; 10 = most severe pain.
Numeric Rating Scale (NRS) for Pain Severity
时间窗: Perioperatively (midway through procedure) and immediately following the procedure.
During and immediately following the procedure, patients will be momentarily interrupted to give a brief NRS verbal response question measure of their level of acute pain, this is on a scale of 0-10; 10 = most severe pain.
次要结局
- State Trait Anxiety Inventory Total Score(10 minutes preoperatively (baseline) and within 10 minutes postoperatively (in the recovery room.)
- State Trait Anxiety Inventory Total Score(10 minutes preoperatively (baseline) and within 10 minutes postoperatively (in the recovery room.)
- Satisfaction with Surgery(Within 10 minutes postoperatively (in the recovery room).)
- iGroup Presence Questionnaire (IPQ) Score(Within 10 minutes postoperatively (in the recovery room).)
- Virtual Reality Impressions Scale(Within 10 minutes postoperatively (in the recovery room).)
- Numeric Rating Scale (NRS) for Anxiety Severity(Perioperatively (midway through procedure) and immediately following the procedure.)
- Numeric Rating Scale (NRS) for Discomfort Severity(Perioperatively (midway through procedure) and immediately following the procedure.)
- PROMIS Pain Intensity Scale Total Score(Within 10 minutes postoperatively (in the recovery room))
- Numeric Rating Scale (NRS) for Discomfort Severity(Perioperatively (midway through procedure) and immediately following the procedure.)
- Numeric Rating Scale (NRS) for Anxiety Severity(Perioperatively (midway through procedure) and immediately following the procedure.)
- PROMIS Pain Intensity Scale Total Score(Within 10 minutes postoperatively (in the recovery room))
- National Comprehensive Cancer Network (NCCN) Anxiety Thermometer Score (adapted from Distress Thermometer)(10 minutes preoperatively (baseline) and within 10 minutes postoperatively (in the recovery room.)
- Satisfaction with Surgery(Within 10 minutes postoperatively (in the recovery room).)
- iGroup Presence Questionnaire (IPQ) Score(Within 10 minutes postoperatively (in the recovery room).)
- Virtual Reality Impressions Scale(Within 10 minutes postoperatively (in the recovery room).)
研究者
Renée El-Gabalawy
Principal Investigator
University of Manitoba