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Funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interactive VR | Experimental | Patients will be wearing a virtual reality headset preloaded with an interactive VR scenario. |
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| Static VR | Experimental | Patients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario. |
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| Control | No Intervention | Patients will not be wearing any virtual reality headset. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmileyScope Virtual Reality Headset | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | up to 1 day |
| 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] | up to 1 day |
| Subjective Pre-operative Pain | Pain will be measured via numeric Likert pain scale [0-10; 0 = no pain, 10 = highest pain] | up to 1 day |
| 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] | up to 1 day |
| 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?" "How helpful was VR in managing your vasectomy today" (0 is least helpful, 10 is most helpful)" | up to 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological Intra-operative Heart Rate | Heart rate will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist. | up to 1 day |
| Physiological Intra-operative Oxygen Saturation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farhan Qureshi, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desai Sethi Urology Institute, University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interactive Virtual Reality (VR) | Patients will be wearing a virtual reality (VR) headset preloaded with an interactive VR scenario. 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. |
| FG001 | Static Virtual Reality (VR) | Patients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario. 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. |
| FG002 | Control | Patients will not be wearing any virtual reality headset. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Interactive VR | Patients will be wearing a virtual reality headset preloaded with an interactive VR scenario. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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] | Posted | Median | Inter-Quartile Range | score on a scale | up to 1 day |
|
1 Day
Adverse Events (AEs) were collected only on the day of procedure (day of vasectomy)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interactive VR | Patients will be wearing a virtual reality headset preloaded with an interactive VR scenario. 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal Reaction | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Russell Saltzman | University of Miami, Miller School of Medicine | 3052431152 | R.Saltzman@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2022 | Sep 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Patients will be randomized into one of three groups (interactive virtual reality, static virtual reality, and no virtual reality).
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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.
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Oxygen saturation will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist.
| up to 1 day |
| Physiological Intra-operative Skin Temperature | Skin temperature will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist. | up to 1 day |
| Physiological Post-operative Heart Rate | Heart rate will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist. | up to 1 day |
| Physiological Post-operative Oxygen Saturation | Oxygen saturation will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist. | up to 1 day |
| Physiological Post-operative Skin Temperature | Skin temperature will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist. | up to 1 day |
| BG001 | Static VR | Patients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario. 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. |
| BG002 | Control | Patients will not be wearing any virtual reality headset. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Static VR |
Patients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario. 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. |
| OG002 | Control | Patients will not be wearing any virtual reality headset. |
|
|
| 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] | Posted | Median | Inter-Quartile Range | score on a scale | up to 1 day |
|
|
|
| Primary | Subjective Pre-operative Pain | Pain will be measured via numeric Likert pain scale [0-10; 0 = no pain, 10 = highest pain] | Posted | Mean | Standard Deviation | score on a scale | up to 1 day |
|
|
|
| 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] | Posted | Mean | Standard Deviation | score on a scale | up to 1 day |
|
|
|
| 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?" "How helpful was VR in managing your vasectomy today" (0 is least helpful, 10 is most helpful)" | Only Participants randomized to one of the two VR arms were asked to complete the post procedure satisfaction survey | Posted | Mean | Standard Deviation | score on a scale | up to 1 day |
|
|
|
| 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. | Posted | Mean | Standard Deviation | beats per minute (BPM) | up to 1 day |
|
|
|
| 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. | Data was not collected due to an oversight in the study design. All vital sign parameters were planned to be collected via FitBit Versa 8. However, once the research team realized it was not possible to capture oxygen saturation and temperature with this device, the protocol should have been amended. A Note-to-File was created to document this protocol deviation. | Posted | up to 1 day |
|
|
| 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. | Data was not collected due to an oversight in the study design. All vital sign parameters were planned to be collected via FitBit Versa 8. However, once the research team realized it was not possible to capture oxygen saturation and temperature with this device, the protocol should have been amended. A Note-to-File was created to document this protocol deviation. | Posted | up to 1 day |
|
|
| 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. | Posted | Mean | Standard Deviation | beats per minute (BPM) | up to 1 day |
|
|
|
| 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. | Data was not collected due to an oversight in the study design. All vital sign parameters were planned to be collected via FitBit Versa 8. However, once the research team realized it was not possible to capture oxygen saturation and temperature with this device, the protocol should have been amended. A Note-to-File was created to document this protocol deviation. | Posted | up to 1 day |
|
|
| 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. | Data was not collected due to an oversight in the study design. All vital sign parameters were planned to be collected via FitBit Versa 8. However, once the research team realized it was not possible to capture oxygen saturation and temperature with this device, the protocol should have been amended. A Note-to-File was created to document this protocol deviation. | Posted | up to 1 day |
|
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Static VR | Patients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario. 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. | 0 | 40 | 0 | 40 | 1 | 40 |
| EG002 | Control | Patients will not be wearing any virtual reality headset. | 0 | 40 | 0 | 40 | 0 | 40 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| How helpful was VR in managing your vasectomy today? (0 least helpful, 10 most helpful) |
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