Virtual Reality During Ultrasound Examination of Women With Endometriosis
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessments of pain through pain score parameter
研究概览
简要总结
To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during ultrasound exam in patients with endometriosis in the outpatient setting.
详细描述
A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo ultrasound exam either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patient needed ultrasound with the diagnosis of endometriosis. the diagnosis of endometriosis is based on ultrasound finding or previous surgery.
排除标准
- •women who reported the use of analgesia 6 hours prior to the procedure
结局指标
主要结局
Assessments of pain through pain score parameter
时间窗: 20 minutes
Assessments of pain through pain score parameter of the NRS questionnaire. Pain will be measured using the Numeric Rating Scale (NRS) which is a 11 point scale from 0 to 10 which is a validated score of measuring pain and anxiety in which 0 is no pain and 10 is the worst imaginable pain and or anxiety.
Assessments of pain through physiological parameters
时间窗: 10 minutes
Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using Heart Rate-beats per minute.
次要结局
未报告次要终点