Virtual Reality Technology for Vasectomy Pain Modulation

Modulating Intraoperative Vasectomy Pain Using the SmileyScope Virtual Reality Interface

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.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative; Vasectomy; Anxiety Postoperative
• Intervention / Treatment: Device: SmileyScope Virtual Reality Headset

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Desai Sethi Urology Institute, University of Miami Miller School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interactive VR; Patients will be wearing a virtual reality headset preloaded with an interactive VR scenario.	Device: SmileyScope Virtual Reality Headset; 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.
Experimental: Static VR; Patients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario.	Device: SmileyScope Virtual Reality Headset; 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.
No Intervention: Control; 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]	up to 1 day
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]	up to 1 day
Subjective Pre-operative Pain	Pain will be measured via numeric Likert pain scale [0-10; 0 = no pain, 10 = highest pain]	up to 1 day
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]	up to 1 day
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?" "How helpful was VR in managing your vasectomy today" (0 is least helpful, 10 is most helpful)"	up to 1 day

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.	up to 1 day
Physiological Intra-operative Oxygen Saturation	Oxygen saturation will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist.	up to 1 day
Physiological Intra-operative Skin Temperature	Skin temperature will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist.	up to 1 day
Physiological Post-operative Heart Rate	Heart rate will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist.	up to 1 day
Physiological Post-operative Oxygen Saturation	Oxygen saturation will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist.	up to 1 day
Physiological Post-operative Skin Temperature	Skin temperature will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist.	up to 1 day

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Farhan Qureshi, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Actual): March 28, 2024
• Study Completion (Actual): March 28, 2024

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: 20220880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No