The Effect of Virtual Reality on Anxiety During Vasectomy

Study Overview
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Brief Summary
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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
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The aim of the study is to evaluate the efficacy of virtual reality goggles (VRG) for improving the patient's experience during vasectomy procedure. 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).

Official Title
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The Effect of Virtual Reality on Anxiety During Vasectomy

Conditions
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Vasectomy, Virtual Reality

Intervention / Treatment
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* Procedure: Virtual Reality during vasectomy
* Procedure: Standard Vasectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |