Anxiety Postoperative, Pain, Postoperative, Vasectomy
Conditions
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.
Interventions
DEVICESmileyScope 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.
Sponsors
University of Miami
Study design
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.
Intervention model description
Patients will be randomized into one of three groups (interactive virtual reality, static virtual reality, and no virtual reality).
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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 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 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 40 |
| Control Patients will not be wearing any virtual reality headset. | 40 |
| Total | 120 |
Baseline characteristics
| Characteristic | Interactive VR | Static VR | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 39.33 years STANDARD_DEVIATION 7.32 | 40.58 years STANDARD_DEVIATION 4.92 | 40.13 years STANDARD_DEVIATION 4.72 | 40.01 years STANDARD_DEVIATION 5.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 25 Participants | 23 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 15 Participants | 16 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) White | 36 Participants | 32 Participants | 31 Participants | 99 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 40 Participants | 40 Participants | 40 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 1 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Post-operative Anxiety
Anxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score \[Range 20-80; 20 = low anxiety, 80 = high anxiety\]
Time frame: up to 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interactive VR | Post-operative Anxiety | 14.5 score on a scale |
| Static VR | Post-operative Anxiety | 14 score on a scale |
| Control | Post-operative Anxiety | 15 score on a scale |
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)
Time frame: up to 1 day
Population: Only Participants randomized to one of the two VR arms were asked to complete the post procedure satisfaction survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interactive VR | 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 |
| Interactive VR | 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 |
| Static VR | Post-procedure Satisfaction | How satisfied were you with today's procedure? (0 not satisfied at all; 10 most satisfied) | 4.92 score on a scale | Standard Deviation 0.28 |
| Static VR | Post-procedure Satisfaction | How helpful was VR in managing your vasectomy today? (0 least helpful, 10 most helpful) | 4.06 score on a scale | Standard Deviation 1.04 |
| Control | Post-procedure Satisfaction | How satisfied were you with today's procedure? (0 not satisfied at all; 10 most satisfied) | 4.61 score on a scale | Standard Deviation 1.02 |
Primary
Pre-operative Anxiety
Anxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score \[Range 20-80; 20 = low anxiety, 80 = high anxiety\]
Time frame: up to 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interactive VR | Pre-operative Anxiety | 14 score on a scale |
| Static VR | Pre-operative Anxiety | 13.5 score on a scale |
| Control | Pre-operative Anxiety | 14 score on a scale |
Primary
Subjective Post-operative Pain
Pain will be measured via numeric Likert pain scale; compared to baseline pain scale in pre-operative period \[0-10; 0 = no pain, 10 = highest pain\]
Time frame: up to 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interactive VR | Subjective Post-operative Pain | 2.875 score on a scale | Standard Deviation 1.571 |
| Static VR | Subjective Post-operative Pain | 2.447 score on a scale | Standard Deviation 1.554 |
| Control | Subjective Post-operative Pain | 2.325 score on a scale | Standard Deviation 1.623 |
Primary
Subjective Pre-operative Pain
Pain will be measured via numeric Likert pain scale \[0-10; 0 = no pain, 10 = highest pain\]
Time frame: up to 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interactive VR | Subjective Pre-operative Pain | 0.05 score on a scale | Standard Deviation 0.32 |
| Static VR | Subjective Pre-operative Pain | 0 score on a scale | Standard Deviation 0 |
| Control | Subjective Pre-operative Pain | 0.05 score on a scale | Standard Deviation 0.316 |
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.
Time frame: up to 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interactive VR | Physiological Intra-operative Heart Rate | 77.8 beats per minute (BPM) | Standard Deviation 13.5 |
| Static VR | Physiological Intra-operative Heart Rate | 75.2 beats per minute (BPM) | Standard Deviation 10.9 |
| Control | Physiological Intra-operative Heart Rate | 77.2 beats per minute (BPM) | Standard Deviation 12.1 |
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.
Time frame: up to 1 day
Population: 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.
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.
Time frame: up to 1 day
Population: 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.
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.
Time frame: up to 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interactive VR | Physiological Post-operative Heart Rate | 75.9 beats per minute (BPM) | Standard Deviation 12.2 |
| Static VR | Physiological Post-operative Heart Rate | 75.9 beats per minute (BPM) | Standard Deviation 12.2 |
| Control | Physiological Post-operative Heart Rate | 75.1 beats per minute (BPM) | Standard Deviation 13.9 |
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.
Time frame: up to 1 day
Population: 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.
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.
Time frame: up to 1 day
Population: 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.