Virtual Reality Technology for Vasectomy Pain Modulation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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.
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| No Intervention: Control Patients will not be wearing any virtual reality headset. |
Outcome Measures
Primary Outcome Measures
- Pre-operative anxiety [Immediate pre-operative period]
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 [Immediate post-operative period]
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 [Immediate pre-operative period]
Pain will be measured via numeric Likert pain scale [0-10; 0 = no pain, 10 = highest pain]
- Subjective Post-operative pain [Immediate post-operative period]
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 [Immediate post-operative period]
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?"
Secondary Outcome Measures
- Physiological Intra-operative heart rate [During the vasectomy procedure]
Heart rate will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist.
- Physiological Intra-operative oxygen saturation [During the vasectomy procedure]
Oxygen saturation will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist.
- Physiological Intra-operative skin temperature [During the vasectomy procedure]
Skin temperature will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist.
- Physiological Post-operative heart rate [Immediate post-operative period]
Heart rate will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist.
- Physiological Post-operative oxygen saturation [Immediate post-operative period]
Oxygen saturation will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist.
- Physiological Post-operative skin temperature [Immediate post-operative period]
Skin temperature will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult males 18 years or older who are undergoing elective vasectomy
Exclusion Criteria:
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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
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History of chronic pain disorder or chronic narcotic use
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Significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancer, etc. which could compromise the physical function of the headset.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Desai Sethi Urology Institute, University of Miami Miller School of Medicine | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
Investigators
- Principal Investigator: Ranjith Ramasamy, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20220880