VasectomyNCT05591274
Virtual Reality Technology for Vasectomy Pain Modulation
A study testing SmileyScope Virtual Reality Headset in people with Vasectomy and Pain, Postoperative, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vasectomy, Pain, Postoperative, Anxiety Postoperative
- What is being tested?
- SmileyScope Virtual Reality Headset
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2022to 28 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males 18 years or older who are undergoing elective vasectomy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Desai Sethi Urology Institute, University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Modulating Intraoperative Vasectomy Pain Using the SmileyScope Virtual Reality Interface
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.
Read the 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.
- Conditions
- Vasectomy, Pain, Postoperative, Anxiety Postoperative
- Being tested
- SmileyScope Virtual Reality Headset
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmileyScope Virtual Reality HeadsetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive VR | Experimental | Patients will be wearing a virtual reality headset preloaded with an interactive VR scenario. Receives: Device: SmileyScope Virtual Reality Headset |
| Static VR | Experimental | Patients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario. Receives: Device: SmileyScope Virtual Reality Headset |
| Control | No intervention | Patients will not be wearing any virtual reality headset. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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)"
Measured: up to 1 day
Secondary outcomes (6)
Physiological Intra-operative Heart Rate
Heart rate will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist.
Measured: up to 1 day
Physiological Intra-operative Oxygen Saturation
Oxygen saturation will be measured intra-operatively using a FitBit Versa 3 device worn on the patient's wrist.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start17 Nov 2022
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VasectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into one of three groups (interactive virtual reality, static virtual reality, and no virtual reality).
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farhan Qureshi, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591274
- Sponsor's protocol ID
- 20220880
- Status last verified
- Nov 2024
- First submitted
- 17 Oct 2022
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Intraoperative Vasectomy Pain Using the SmileyScope Virtual Reality Interface
- ClinicalTrials.gov ID
- NCT05591274
- Acronym / sponsor ID
- 20220880
- Conditions
- Vasectomy, Pain, Postoperative, Anxiety Postoperative
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be randomized into one of three groups (interactive virtual reality, static virtual reality, and no virtual reality).
| Arm | Type | Receives |
|---|---|---|
| Interactive VR | Experimental | Device: SmileyScope Virtual Reality HeadsetPatients will be wearing a virtual reality headset preloaded with an interactive VR scenario. |
| Static VR | Experimental | Device: SmileyScope Virtual Reality HeadsetPatients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario. |
| Control | No intervention | –Patients will not be wearing any virtual reality headset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult males 18 years or older who are undergoing elective vasectomy
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmileyScope Virtual Reality HeadsetThe 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. | Device | Interactive VR, Static VR |
Primary outcome
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)"
6 secondary outcomes
Physiological Intra-operative Heart Rate
Time frame: up to 1 day
Physiological Intra-operative Oxygen Saturation
Time frame: up to 1 day
Physiological Intra-operative Skin Temperature
Time frame: up to 1 day
Physiological Post-operative Heart Rate
Time frame: up to 1 day
Physiological Post-operative Oxygen Saturation
Time frame: up to 1 day
Physiological Post-operative Skin Temperature
Time frame: up to 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farhan Qureshi, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmileyScope Virtual Reality Headset in people with Vasectomy and Pain, Postoperative, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative Anxiety (time frame: up to 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.