Preoperative virtual reality video to reduce anxiety in women undergoing office hysteroscopy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The primary outcome measured is the comparison of preoperative anxiety scores as assessed by
研究概览
简要总结
Hysteroscopy is the gold standard for diagnosis and treatment of intrauterine pathologies. Traditionally, it is performed under anaesthesia. Today, because of the miniaturization of the instru ments, hysteroscopy, both diagnostic and operative is feasible without anaesthesia in the physician’s office, where it’s possible that the patient can walk in and walk out in less than an hour. The challenge is anxiety faced by women prior to office hysteroscopy (OH) in anticipation of pain. Virtual reality (VR) is a non - pharmacological intervention to reduce pre- operative anxiety, by sensitising patients of the planned surgery and the operating room. This helps in reducing their fear. The VR consists of a video of 4 minutes duration explaining the procedure of OH in general and not specific to any pathology, and care to be taken before and after hysteroscopy.The VR is made with the help of a UNITY 3D software platform using C# computer language. After experiencing VR, doubts will be clarified by the health care provider and a visual analogue score of anxiety (VAS - A) is noted. We aim to do an open labelled randomised controlled trial and compare the anxiety rates between both groups of women undergoing office hysteroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women above 18 years of age planned for OH.
- •Those who are able to provide informed consent.
排除标准
- •Those who have hearing problems.
- •Those who cannot give consent.
- •Women who have undergone previous office hysteroscopy by vaginoscopy technique.
- •Women with a prior history of psychological disease.
结局指标
主要结局
The primary outcome measured is the comparison of preoperative anxiety scores as assessed by
时间窗: At baseline
VAS - A, in both interventional and control groups.
时间窗: At baseline
次要结局
- To compare the postoperative pain scores, success rate & Likert scale of satisfaction in the interventional group & the control group.(At baseline)
研究者
Tanvir
Tanvir Hospital
