The Impact of Virtual Reality Technology in the Era of See & Treat Hysteroscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Respiratory rate (RR) pre procedure
研究概览
简要总结
The aim of the study is to evaluate the feasibility and effectiveness of virtual reality technology in outpatient hysteroscopy to improve pain and anxiety management and spread the diffusion of see & treat philosophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Respiratory rate (RR) pre procedure
时间窗: 1 minute before the procedure
Respiratory rate (RR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).
Pain post procedure
时间窗: 1 minute after the procedure
Level of pain reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst pain (subjective criteria), during diagnostic and operative procedures.
Anxiety pre procedure
时间窗: 1 minute before the procedure
Level of anxiety the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no anxiety to 10 corresponding to the worst anxiety (subjective criteria), before undergoing diagnostic and operative procedures.
Pain pre procedure
时间窗: 1 minute before the procedure
Level of pain the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain to 10 corresponding to the worst pain (subjective criteria), before undergoing diagnostic and operative procedures.
Heart rate (HR) pre procedure
时间窗: 1 minute before the procedure
Heart rate (HR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).
Anxiety post procedure
时间窗: 1 minute after the procedure
Level of anxiety reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst anxiety (subjective criteria), during diagnostic and operative procedures.
Respiratory rate (RR) during procedure
时间窗: 5 minutes after the start of the procedure
Respiratory rate (RR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).
Heart rate (HR) during procedure
时间窗: 5 minutes after the start of the procedure
Heart rate (HR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).
次要结局
- Satisfaction rate(5 minutes after the procedure)
- Suspension rate of procedure(During procedure)
- Time of procedure(During procedure)
- Side effects(5 minutes after the procedure)
研究者
Brunella Zizolfi
Assistant Professor
Federico II University