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Clinical Trials/NCT04258514
NCT04258514
Withdrawn
Not Applicable

The Effect of Virtual Reality on Anxiety During Vasectomy

University of Nebraska0 sitesApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vasectomy
Sponsor
University of Nebraska
Primary Endpoint
Procedure anxiety
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
June 23, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Procedure anxiety

Time Frame: 10 minutes after procedure ends

Procedure anxiety measured by Beck Anxiety Inventory

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