Overactive BladderNCT05928910
Virtual Reality (VR) During Peripheral Nerve Evaluation (PNE) Procedure
A study testing SmileyScope VR in people with Overactive Bladder, run by University of Miami.
Trial summary
The purpose of this research is to evaluate whether or not wearing a virtual reality headset affects pain and anxiety in patients undergoing percutaneous nerve evaluation (PNE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- SmileyScope VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing elective peripheral nerve evaluation studies for pelvic floor dysfunction
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
- Significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancers, etc., which could compromise the physical function of the headset
About this study
Official title: Decreasing Intraprocedural Peripheral Nerve Evaluation (PNE) Pain and Anxiety Using the SmileyScope Virtual Reality
The purpose of this research is to evaluate whether or not wearing a virtual reality headset affects pain and anxiety in patients undergoing percutaneous nerve evaluation (PNE).
- Conditions
- Overactive Bladder
- Being tested
- SmileyScope VR, Standard of Care Treatment
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmileyScope VRDevice
The SmileyScope Virtual Reality Headset is a VR headset to reduce pain and anxiety undergoing medical procedures. The device comes pre-loaded with a static virtual reality scenario. Participants will use the device in person when coming to clinic during an in-person, one time PNE procedure.
Standard of Care TreatmentOther
Participants in this group will receive standard of care treatment during an in-person, one time PNE procedure.
| Study group | Role | What they receive |
|---|---|---|
| SmileyScope VR Group | Experimental | Participants in this group will wear the SmileyScope VR set during the PNE procedure for approximately 40 minutes. Receives: Device: SmileyScope VR |
| No VR Group | Experimental | Participants in this group will receive standard of care treatment. Receives: Other: Standard of Care Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Pain as Measured by Numeric Pain Scale
Pain will be measured using the numeric pain scale. Scores range from 0-10. Higher scores indicate worse pain.
Measured: Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure)
Change in Anxiety as Measured by State Trait Anxiety Inventory
Anxiety will be measured using the State Trait Anxiety Inventory. Scores range from 0-24. Higher scores indicate greater anxiety.
Measured: Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure)
Secondary outcomes (2)
Satisfaction with Procedure as measured by Likert Scale
Satisfaction with be measured by likert scale. Scores range from (1) very unsatisfied with today's procedure to (5) very satisfied with today's procedure.
Measured: up to one hour post-procedure
Feasibility for the Utilization of the Smiley Scope VR Headset by Likert Scale
Feasibility will be measured by a 5-point Likert scale for the utilization of the Smiley Scope VR Headset. Scores range from (1) very unhelpful in managing your pain and anxiety associated with the PNE procedure to (5) very helpful in managing your pain and anxiety associated with the PNE procedure.
Measured: up to one hour post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start30 Jan 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Why it stopped: decided to not proceed with study due to lack of personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raveen Syan, University of Miami
- Investigators
- Raveen Syan, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928910
- Sponsor's protocol ID
- 20230398
- Status last verified
- Oct 2023
- First submitted
- 23 Jun 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- 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 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Intraprocedural Peripheral Nerve Evaluation (PNE) Pain and Anxiety Using the SmileyScope Virtual Reality
- ClinicalTrials.gov ID
- NCT05928910
- Acronym / sponsor ID
- 20230398
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: decided to not proceed with study due to lack of personnel
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate whether or not wearing a virtual reality headset affects pain and anxiety in patients undergoing percutaneous nerve evaluation (PNE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SmileyScope VR Group | Experimental | Device: SmileyScope VRParticipants in this group will wear the SmileyScope VR set during the PNE procedure for approximately 40 minutes. |
| No VR Group | Experimental | Other: Standard of Care TreatmentParticipants in this group will receive standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing elective peripheral nerve evaluation studies for pelvic floor dysfunction
Key exclusion criteria (2 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
- Significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancers, 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 VRThe SmileyScope Virtual Reality Headset is a VR headset to reduce pain and anxiety undergoing medical procedures. The device comes pre-loaded with a static virtual reality scenario. Participants will use the device in person when coming to clinic during an in-person, one time PNE procedure. | Device | SmileyScope VR Group |
| Standard of Care TreatmentParticipants in this group will receive standard of care treatment during an in-person, one time PNE procedure. | Other | No VR Group |
Primary outcome
Change In Pain as Measured by Numeric Pain Scale
Time frame: Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure)
Pain will be measured using the numeric pain scale. Scores range from 0-10. Higher scores indicate worse pain.
Change in Anxiety as Measured by State Trait Anxiety Inventory
Time frame: Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure)
Anxiety will be measured using the State Trait Anxiety Inventory. Scores range from 0-24. Higher scores indicate greater anxiety.
2 secondary outcomes
Satisfaction with Procedure as measured by Likert Scale
Time frame: up to one hour post-procedure
Feasibility for the Utilization of the Smiley Scope VR Headset by Likert Scale
Time frame: up to one hour post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- 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.
Raveen Syan, MD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A study testing SmileyScope VR in people with Overactive Bladder, run by University of Miami.
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 2 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: withdrawn, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change In Pain as Measured by Numeric Pain Scale (time frame: Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure)). The study lists 2 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 6 Oct 2023.