跳至主要内容
临床试验/CTRI/2024/07/071148
CTRI/2024/07/071148尚未招募4 期

Preoperative virtual reality video to reduce anxiety in women undergoing office hysteroscopy

Tanvir1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月5日最近更新:

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

发起方
Tanvir
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Tanvir

Tanvir Hospital

研究点 (1)

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