Virtual Reality Technology for Vasectomy Pain Modulation

Pain, Postoperative Clinical Trial

Official title:

Modulating Intraoperative Vasectomy Pain Using the SmileyScope Virtual Reality Interface

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05591274
• Other study ID #: 20220880
• Status: Terminated
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: March 28, 2024

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: March 28, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Postoperative
• Pain, Postoperative
• Vasectomy

Intervention

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.

Locations

Country	Name	City	State
United States	Desai Sethi Urology Institute, University of Miami Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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