Modulating Intraoperative Vasectomy Pain Using the SmileyScope Virtual Reality Interface
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Miami
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Pre-operative Anxiety
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
Patients will be randomized into one of three groups (interactive virtual reality, static virtual reality, and no virtual reality). Randomization sequence will be generated using a validated random number generator, and allocation concealment will be achieved via opaque envelope. Treatment (vasectomy with interactive VR, vasectomy with static VR, or vasectomy with no VR) will be known to patient and care provider only once the vasectomy procedure begins.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Pre-operative Anxiety
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Physiological Intra-operative Heart Rate(up to 1 day)
- Physiological Intra-operative Skin Temperature(up to 1 day)
- Physiological Post-operative Oxygen Saturation(up to 1 day)
- Physiological Intra-operative Oxygen Saturation(up to 1 day)
- Physiological Post-operative Heart Rate(up to 1 day)
- Physiological Post-operative Skin Temperature(up to 1 day)