TerminatedNot Applicable

Virtual Reality Technology for Vasectomy Pain Modulation

Stopped: Funding

United States120 participantsStarted 2022-11-17

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Pre-operative Anxiety

Timeframe: up to 1 day

Post-operative Anxiety

Timeframe: up to 1 day

Subjective Pre-operative Pain

Timeframe: up to 1 day

Subjective Post-operative Pain

Timeframe: up to 1 day

Post-procedure Satisfaction

Timeframe: up to 1 day

Trial details

NCT IDNCT05591274

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-28

Results submitted2024-11-20

View on ClinicalTrials.gov More Vasectomy trials