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Virtual Reality Technology for Vasectomy Pain Modulation

NCT05591274 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-12-13

Study results available
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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.

Conditions

  • Vasectomy
  • Pain, Postoperative
  • Anxiety Postoperative

Interventions

DEVICE

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.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Farhan Qureshi, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-17
Primary Completion
2024-03-28
Completion
2024-03-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05591274 on ClinicalTrials.gov