The Effect of Virtual Reality on Anxiety During Vasectomy

Not Applicable

Withdrawn

• Conditions: Virtual Reality; Vasectomy
• Interventions: Procedure: Virtual Reality during vasectomy; Procedure: Standard Vasectomy

• Registration Number: NCT04258514
• Lead Sponsor: University of Nebraska

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).

Study Timeline

• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Study Start: 2021-04-01
• Primary Completion: 2021-06-23
• Study Completion: 2021-06-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-12
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Vasectomy	Virtual Reality during vasectomy	This group of men will undergo vasectomy while wearing VR goggles.
Standard Vasectomy	Standard Vasectomy	This group of men will undergo a standard vasectomy without using VR goggles.

Primary Outcome Measures

Name	Time	Method
Procedure anxiety	10 minutes after procedure ends	Procedure anxiety measured by Beck Anxiety Inventory