The Effect of Virtual Reality on Anxiety During Vasectomy

NCT ID: NCT04258514

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-06-23

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).

Conditions

Vasectomy; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality Vasectomy

This group of men will undergo vasectomy while wearing VR goggles.

Group Type: EXPERIMENTAL

Virtual Reality during vasectomy

Intervention Type: PROCEDURE

Virtual Reality

Standard Vasectomy

This group of men will undergo a standard vasectomy without using VR goggles.

Group Type: EXPERIMENTAL

Standard Vasectomy

Intervention Type: PROCEDURE

No Virtual Reality

Interventions

Virtual Reality during vasectomy

Virtual Reality

Intervention Type: PROCEDURE

Standard Vasectomy

No Virtual Reality

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher M Deibert, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Other Identifiers

0034-20-EP

Identifier Type: -

Identifier Source: org_study_id