A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Assessments of pain through physiological parameters
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 operative hysteroscopy 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 operative hysteroscopy 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •. Women with suspected infection
- •women considered not suitable to undergo an office hysteroscopy
- •women who reported the use of analgesia 6 hours prior to the procedure.
排除标准
- •patient needed office hysteroscopy
结局指标
主要结局
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.
Assessments of pain through pain score parameter
时间窗: 10 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.
次要结局
未报告次要终点
研究者
michal roll
Director, Head of Clinical Trails Department, Principal Investigator, Clinical Professor
Tel-Aviv Sourasky Medical Center