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临床试验/NCT04258514
NCT04258514撤回不适用

The Effect of Virtual Reality on Anxiety During Vasectomy

University of Nebraska0 个研究点开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Procedure anxiety

研究概览

简要总结

The primary purpose of the study is to determine if the use of Virtual Reality (VR) goggles reduces the degree of anxiety patients experience during vasectomy procedures. The eligibility criteria include a.) appropriate age (19-100 years); b.) undergoing elective vasectomy procedure for purpose of desired sterility; c.) acceptance of wearing goggles; d) able to provide informed consent.There will be two groups, Group A will wear VR goggles and Group B will not. Evaluations will be done by survey to include questions regarding the level of anxiety experienced during the procedure, along with satisfaction scores of the experience.

详细描述

  1. The aim of the study is to evaluate the efficacy of virtual reality goggles (VRG) for improving the patient's experience during vasectomy procedure.
  2. The secondary aim is to determine if VRG reduces the level of anxiety experienced during vasectomy procedure.

VR is an immersive, multisensory experience in a three-dimensional environment designed to replicate a real world. It has been shown in multiple studies to decrease acute and chronic pain in a variety of clinical settings. The mechanism is due to distraction by activating visual, auditory and proprioceptive senses. One example of this is a report by G. Pooja et. al. where in VR goggles reduced pain and medication use during orthopedic procedures (1). Another study found decrease in pain in medically treated patients (n=50 patients in 2 groups) after a 15 minute VR viewing on pain reduction compared to 2 -D viewing (2).

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

盲法说明

cannot make due to either wearing or not wearing the VR device

入排标准

年龄范围
19 Years 至 100 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Appropriate age range (19-100 years)
  • Undergoing elective vasectomy procedure in the urology clinic
  • Willing to sign consent to participate in the study

排除标准

  • Visually impaired (blind)
  • 18 years of age or younger
  • Subjects under the influence of medications will not be approached regarding study participation.

结局指标

主要结局

Procedure anxiety

时间窗: 10 minutes after procedure ends

Procedure anxiety measured by Beck Anxiety Inventory

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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