The Effect of Virtual Reality on Anxiety During Vasectomy

Virtual Reality Clinical Trial

Official title:

The Effect of Virtual Reality on Anxiety During Vasectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04258514
• Other study ID #: 0034-20-EP
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 23, 2021

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 23, 2021
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vasectomy
• Virtual Reality

Intervention

Procedure:
• Virtual Reality during vasectomy
Virtual Reality
• Standard Vasectomy
No Virtual Reality

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure anxiety	Procedure anxiety measured by Beck Anxiety Inventory	during vasectomy Procedure
Primary	Procedure anxiety	Procedure anxiety measured by Beck Anxiety Inventory	10 minutes prior to procedure start
Primary	Procedure anxiety	Procedure anxiety measured by Beck Anxiety Inventory	10 minutes after procedure ends