Virtual Reality Technology for Vasectomy Pain Modulation

Not Applicable

Terminated

Conditions: Anxiety Postoperative
Pain, Postoperative
Vasectomy

Interventions: Device: SmileyScope Virtual Reality Headset

Registration Number: NCT05591274

Lead Sponsor: University of Miami

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 120

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interactive VR	SmileyScope Virtual Reality Headset	Patients will be wearing a virtual reality headset preloaded with an interactive VR scenario.
Static VR	SmileyScope Virtual Reality Headset	Patients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario.

Primary Outcome Measures

Name	Time	Method
Pre-operative Anxiety	up to 1 day	Anxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score \[Range 20-80; 20 = low anxiety, 80 = high anxiety\]
Post-operative Anxiety	up to 1 day	Anxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score \[Range 20-80; 20 = low anxiety, 80 = high anxiety\]
Subjective Pre-operative Pain	up to 1 day	Pain will be measured via numeric Likert pain scale \[0-10; 0 = no pain, 10 = highest pain\]
Subjective Post-operative Pain	up to 1 day	Pain will be measured via numeric Likert pain scale; compared to baseline pain scale in pre-operative period \[0-10; 0 = no pain, 10 = highest pain\]
Post-procedure Satisfaction	up to 1 day	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)"

Secondary Outcome Measures

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