Trial Outcomes & Findings for Virtual Reality Technology for Vasectomy Pain Modulation (NCT NCT05591274)
NCT ID: NCT05591274
Last Updated: 2024-12-13
Results Overview
Anxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score \[Range 20-80; 20 = low anxiety, 80 = high anxiety\]
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
up to 1 day
Results posted on
2024-12-13
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
Control
Patients will not be wearing any virtual reality headset.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Reality Technology for Vasectomy Pain Modulation
Baseline characteristics by cohort
| Measure |
Interactive VR
n=40 Participants
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.
|
Static VR
n=40 Participants
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.
|
Control
n=40 Participants
Patients will not be wearing any virtual reality headset.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.33 years
STANDARD_DEVIATION 7.32 • n=93 Participants
|
40.58 years
STANDARD_DEVIATION 4.92 • n=4 Participants
|
40.13 years
STANDARD_DEVIATION 4.72 • n=27 Participants
|
40.01 years
STANDARD_DEVIATION 5.75 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
120 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
76 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
99 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: up to 1 dayAnxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score \[Range 20-80; 20 = low anxiety, 80 = high anxiety\]
Outcome measures
| Measure |
Interactive VR
n=40 Participants
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.
|
Static VR
n=40 Participants
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.
|
Control
n=40 Participants
Patients will not be wearing any virtual reality headset.
|
|---|---|---|---|
|
Pre-operative Anxiety
|
14 score on a scale
Interval 12.0 to 15.0
|
13.5 score on a scale
Interval 13.0 to 15.0
|
14 score on a scale
Interval 12.0 to 15.0
|
PRIMARY outcome
Timeframe: up to 1 dayAnxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score \[Range 20-80; 20 = low anxiety, 80 = high anxiety\]
Outcome measures
| Measure |
Interactive VR
n=40 Participants
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.
|
Static VR
n=40 Participants
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.
|
Control
n=40 Participants
Patients will not be wearing any virtual reality headset.
|
|---|---|---|---|
|
Post-operative Anxiety
|
14.5 score on a scale
Interval 13.0 to 15.0
|
14 score on a scale
Interval 13.0 to 15.0
|
15 score on a scale
Interval 13.0 to 15.0
|
PRIMARY outcome
Timeframe: up to 1 dayPain will be measured via numeric Likert pain scale \[0-10; 0 = no pain, 10 = highest pain\]
Outcome measures
| Measure |
Interactive VR
n=40 Participants
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.
|
Static VR
n=40 Participants
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.
|
Control
n=40 Participants
Patients will not be wearing any virtual reality headset.
|
|---|---|---|---|
|
Subjective Pre-operative Pain
|
0.05 score on a scale
Standard Deviation 0.32
|
0 score on a scale
Standard Deviation 0
|
0.05 score on a scale
Standard Deviation 0.316
|
PRIMARY outcome
Timeframe: up to 1 dayPain will be measured via numeric Likert pain scale; compared to baseline pain scale in pre-operative period \[0-10; 0 = no pain, 10 = highest pain\]
Outcome measures
| Measure |
Interactive VR
n=40 Participants
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.
|
Static VR
n=40 Participants
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.
|
Control
n=40 Participants
Patients will not be wearing any virtual reality headset.
|
|---|---|---|---|
|
Subjective Post-operative Pain
|
2.875 score on a scale
Standard Deviation 1.571
|
2.447 score on a scale
Standard Deviation 1.554
|
2.325 score on a scale
Standard Deviation 1.623
|
PRIMARY outcome
Timeframe: up to 1 dayPopulation: Only Participants randomized to one of the two VR arms were asked to complete the post procedure satisfaction survey
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)"
Outcome measures
| Measure |
Interactive VR
n=40 Participants
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.
|
Static VR
n=40 Participants
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.
|
Control
n=40 Participants
Patients will not be wearing any virtual reality headset.
|
|---|---|---|---|
|
Post-procedure Satisfaction
How satisfied were you with today's procedure? (0 not satisfied at all; 10 most satisfied)
|
4.86 score on a scale
Standard Deviation 0.42
|
4.92 score on a scale
Standard Deviation 0.28
|
4.61 score on a scale
Standard Deviation 1.02
|
|
Post-procedure Satisfaction
How helpful was VR in managing your vasectomy today? (0 least helpful, 10 most helpful)
|
3.92 score on a scale
Standard Deviation 1.3
|
4.06 score on a scale
Standard Deviation 1.04
|
—
|
SECONDARY outcome
Timeframe: up to 1 dayHeart rate will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist.
Outcome measures
| Measure |
Interactive VR
n=40 Participants
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.
|
Static VR
n=40 Participants
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.
|
Control
n=40 Participants
Patients will not be wearing any virtual reality headset.
|
|---|---|---|---|
|
Physiological Intra-operative Heart Rate
|
77.8 beats per minute (BPM)
Standard Deviation 13.5
|
75.2 beats per minute (BPM)
Standard Deviation 10.9
|
77.2 beats per minute (BPM)
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: up to 1 dayPopulation: 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.
Oxygen saturation will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 dayPopulation: 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.
Skin temperature will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 dayHeart rate will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist.
Outcome measures
| Measure |
Interactive VR
n=40 Participants
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.
|
Static VR
n=40 Participants
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.
|
Control
n=40 Participants
Patients will not be wearing any virtual reality headset.
|
|---|---|---|---|
|
Physiological Post-operative Heart Rate
|
75.9 beats per minute (BPM)
Standard Deviation 12.2
|
75.9 beats per minute (BPM)
Standard Deviation 12.2
|
75.1 beats per minute (BPM)
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: up to 1 dayPopulation: 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.
Oxygen saturation will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 dayPopulation: 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.
Skin temperature will be measured post-operatively using a FitBit Versa 3 device worn on the patient's wrist.
Outcome measures
Outcome data not reported
Adverse Events
Interactive VR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Static VR
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Interactive VR
n=40 participants at risk
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.
|
Static VR
n=40 participants at risk
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.
|
Control
n=40 participants at risk
Patients will not be wearing any virtual reality headset.
|
|---|---|---|---|
|
Nervous system disorders
Vasovagal Reaction
|
0.00%
0/40 • 1 Day
Adverse Events (AEs) were collected only on the day of procedure (day of vasectomy)
|
2.5%
1/40 • Number of events 1 • 1 Day
Adverse Events (AEs) were collected only on the day of procedure (day of vasectomy)
|
0.00%
0/40 • 1 Day
Adverse Events (AEs) were collected only on the day of procedure (day of vasectomy)
|
Additional Information
Russell Saltzman
University of Miami, Miller School of Medicine
Phone: 3052431152
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place