Using Virtual Reality (VR) Technology in Gynecological Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 主要终点
- stress cortisol saliva level
研究概览
简要总结
A randomized control trial will be conducted in Assuta Ashdod hospital, in the department of obstetrics and gynecology. Pregnant and non pregnant women, undergoing one of the procedures (external cephalic version,amniocentesis or hysteroscopy), will be approached. All willing patients meeting the criteria will sign an informed consent form will.
After signing informed consent patients will be randomly allocated into three groups:1) control (no use of VR). 2) use of VR googles without positive psychology. 3) use of VR googles with positive psychology.
Before and after the procedure each group will answer pain and anxiety questionnaires. In addition, following, following each procedure, salivary cortisol levels will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •ECV- single tone, breech presentation,gestional age 35-40,unknown drug allergy
- •amniocintesis -single tone,gestional age 16-24 week,
- •hysteroscopy-women age 18-60 , diagnostic procedure,
排除标准
- •ECV-previous cesarian section, contruction,low known plt count ,premature rupture of membrane
- •amniocintesis- Known fetal malformations, amnionitis
- •hysteroscopy-pregnancy, PID
研究组 & 干预措施
control
patients undergoing one of the procedures without using VR device
VR without sound
patients undergoing one of the procedures using VR device without sound
干预措施: VR without positive psychology (Device)
VR with sound
patients undergoing one of the procedures using VR device with sound
干预措施: VR with positive psychology (Device)
结局指标
主要结局
stress cortisol saliva level
时间窗: up to 5 minutes after the procedure
each arm after the procedure will be mesured stress cortisol level in saliva
次要结局
- anxiety levels(up to 5 minutes after)
- pain levels(up to 5 minutes after)