Virtual Reality Technology for Vasectomy Pain Modulation

Study Overview
=================
Brief Summary
-----------------
This study will evaluate whether or not wearing a virtual reality (VR) headset reduces pain and anxiety in patients undergoing vasectomy. The headset being used is the SmileyScope virtual reality interface, a device already undergoing study for approval by the U.S. Food and Drug Administration (FDA) to reduce pain and anxiety in patients aged 4 years and older undergoing needle blood draw or injection procedures. In this study, the SmileyScope virtual reality interface is considered an investigational device because it is not yet approved for use in adult males undergoing vasectomy.

Detailed Description
-----------------
Vasectomy is a safe and effective procedure for permanent sterilization in males. More than 500,000 vasectomies are performed annually in the United States, and that number is expected to grow rapidly in the coming years. The procedure is safe and can be quickly performed in an outpatient setting. Complications of vasectomy are rare, and can include hematoma and infection, spermatic granulomas, and post-vasectomy pain syndrome in rare cases. Like all outpatient surgical procedures where the patient is not under general anesthesia, vasectomies involve intraoperative and immediate post-operative pain. While use of the no-scalpel technique and local anesthetic reduces intraoperative pain, expected operative pain is still one of the main reasons patients cite for not undergoing the procedure. In our current study, the investigators aim to further modulate intraoperative pain using virtual reality goggles. In clinical trials, the SmileyScope device has been shown to reduce procedural pain in the pediatric population during venipuncture or intravenous cannulation. Results from those studies showed a statistically significant reduction in pain during intravenous procedures in the emergency department. This VR headset is undergoing study for approval by the U.S. Food and Drug Administration (FDA) to reduce pain and anxiety in patients aged 4 years and older undergoing needle blood draw or injection procedures. Currently, this device has been granted entrance to the FDA Safer Technologies Program. In this study, the SmileyScope virtual reality interface is considered an investigational device because it is not yet approved for use in adult males undergoing vasectomy. The aim of this study is to investigate whether this same virtual reality modality can be utilized to reduce pain during vasectomies.

Official Title
-----------------
Modulating Intraoperative Vasectomy Pain Using the SmileyScope Virtual Reality Interface

Conditions
-----------------
Vasectomy, Pain, Postoperative, Anxiety Postoperative

Intervention / Treatment
-----------------
* Device: SmileyScope Virtual Reality Headset


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males 18 years or older who are undergoing elective vasectomy Exclusion Criteria: Have a serious comorbid illness or condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study History of chronic pain disorder or chronic narcotic use Significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancer, etc. which could compromise the physical function of the headset.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized into one of three groups (interactive virtual reality, static virtual reality, and no virtual reality).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive VR<br>Patients will be wearing a virtual reality headset preloaded with an interactive VR scenario. | Device: SmileyScope Virtual Reality Headset<br>* The SmileyScope Virtual Reality Headset is a VR headset undergoing study for approval by the U.S. Food and Drug Administration (FDA) to reduce pain and anxiety in patients aged 4 years and older undergoing needle blood draw or injection procedures. Currently, this device has been granted entrance to the FDA Safer Technologies Program. The device comes pre-loaded with either an interactive or static virtual reality scenario.<br>|
| Experimental: Static VR<br>Patients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario. | Device: SmileyScope Virtual Reality Headset<br>* The SmileyScope Virtual Reality Headset is a VR headset undergoing study for approval by the U.S. Food and Drug Administration (FDA) to reduce pain and anxiety in patients aged 4 years and older undergoing needle blood draw or injection procedures. Currently, this device has been granted entrance to the FDA Safer Technologies Program. The device comes pre-loaded with either an interactive or static virtual reality scenario.<br>|
| No Intervention: Control<br>Patients will not be wearing any virtual reality headset. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-operative anxiety | Anxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score [Range 20-80; 20 = low anxiety, 80 = high anxiety] | Immediate pre-operative period | 
| Post-operative anxiety | Anxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score [Range 20-80; 20 = low anxiety, 80 = high anxiety] | Immediate post-operative period | 
| Subjective Pre-operative pain | Pain will be measured via numeric Likert pain scale [0-10; 0 = no pain, 10 = highest pain] | Immediate pre-operative period | 
| Subjective Post-operative pain | Pain will be measured via numeric Likert pain scale; compared to baseline pain scale in pre-operative period [0-10; 0 = no pain, 10 = highest pain] | Immediate post-operative period | 
| Post-procedure satisfaction | Satisfaction will be measured via a questionnaire scored by Likert scale. Questionnaire will ask: How satisfied were you with today's procedure, with 0 being not satisfied at all, and 10 being the most satisfied? If your urologist was using VR, would you be more or less likely to have the procedure? (0 is least likely, 10 is most likely) If your urologist was using VR, would you recommend them to a friend undergoing the same procedure? (0 is least likely to recommend, 10 is most likely to recommend). How helpful was VR in managing your vasectomy today (0 is least helpful, 10 is most helpful) Do you have any comments on today's procedure? | Immediate post-operative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological Intra-operative heart rate | Heart rate will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist. | During the vasectomy procedure | 
| Physiological Intra-operative oxygen saturation | Oxygen saturation will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist. | During the vasectomy procedure | 
| Physiological Intra-operative skin temperature | Skin temperature will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist. | During the vasectomy procedure | 
| Physiological Post-operative heart rate | Heart rate will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist. | Immediate post-operative period | 
| Physiological Post-operative oxygen saturation | Oxygen saturation will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist. | Immediate post-operative period | 
| Physiological Post-operative skin temperature | Skin temperature will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist. | Immediate post-operative period |