Clinical trial NCT05591274: Virtual Reality Technology for Vasectomy Pain Modulation
Official title: Modulating Intraoperative Vasectomy Pain Using the SmileyScope Virtual Reality Interface
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vasectomy
Pain, Postoperative
Anxiety Postoperative
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into one of three groups (interactive virtual reality, static virtual reality, and no virtual reality).
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Pre-operative Anxiety
timeFrame: up to 1 day
measure: Post-operative Anxiety
timeFrame: up to 1 day
measure: Subjective Pre-operative Pain
timeFrame: up to 1 day
measure: Subjective Post-operative Pain
timeFrame: up to 1 day
measure: Post-procedure Satisfaction
timeFrame: up to 1 day
Secondary outcomes:
measure: Physiological Intra-operative Heart Rate
timeFrame: up to 1 day
measure: Physiological Intra-operative Oxygen Saturation
timeFrame: up to 1 day
measure: Physiological Intra-operative Skin Temperature
timeFrame: up to 1 day
measure: Physiological Post-operative Heart Rate
timeFrame: up to 1 day
measure: Physiological Post-operative Oxygen Saturation
timeFrame: up to 1 day
measure: Physiological Post-operative Skin Temperature
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Miami
country: United States
facility: Desai Sethi Urology Institute, University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Farhan Qureshi, PhD
role: PRINCIPAL_INVESTIGATOR
References: