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NCT05591274 · ClinicalTrials.gov registry record · NA
Virtual Reality Technology for Vasectomy Pain Modulation
A NA study, sponsored by University of Miami.
- Terminated
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT05591274: Clinical Trial NA study, sponsored by University of Miami.
NCT05591274 is a NA study that was terminated before completion, run by University of Miami. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05591274, a NA study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
Anxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score \[Range 20-80; 20 = low anxiety, 80 = high anxiety\]
Interventions
- DEVICE SmileyScope Virtual Reality Headset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-11-17 |
| Est. Completion | 2024-03-28 |
| Phase | NA |
Why NCT05591274 stopped before completion
NCT05591274 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which SmileyScope Virtual Reality Headset is the first listed.
NCT05591274 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05591274 about?
NCT05591274 is a clinical study titled "Virtual Reality Technology for Vasectomy Pain Modulation". 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)...
What is the current status of trial NCT05591274?
This trial is currently terminated. It is a NA study. The enrollment target is 120 participants. The study started on 2022-11-17. Estimated completion is 2024-03-28.
What interventions are being tested in trial NCT05591274?
The interventions under investigation include: SmileyScope Virtual Reality Headset (DEVICE).
Who is sponsoring clinical trial NCT05591274?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05591274's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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