The Effect of Virtual Reality on Anxiety During Vasectomy (VR Vasectomy)

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.

Study Overview

• Status: Withdrawn
• Conditions: Virtual Reality; Vasectomy
• Intervention / Treatment: Procedure: Virtual Reality during vasectomy; Procedure: Standard Vasectomy

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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Nebraska Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Visually impaired (blind)
2. 18 years of age or younger
3. Subjects under the influence of medications will not be approached regarding study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Vasectomy; This group of men will undergo vasectomy while wearing VR goggles.	Procedure: Virtual Reality during vasectomy; Virtual Reality
Experimental: Standard Vasectomy; This group of men will undergo a standard vasectomy without using VR goggles.	Procedure: Standard Vasectomy; No Virtual Reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure anxiety	Procedure anxiety measured by Beck Anxiety Inventory	during vasectomy Procedure
Procedure anxiety	Procedure anxiety measured by Beck Anxiety Inventory	10 minutes prior to procedure start
Procedure anxiety	Procedure anxiety measured by Beck Anxiety Inventory	10 minutes after procedure ends

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Christopher M Deibert, MD, MPH, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): June 23, 2021
• Study Completion (Actual): June 23, 2021

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0034-20-EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No