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Virtual Reality for Vasectomy Pain and Anxiety

N/A

Recruiting

Led By Ranjith Ramasamy, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult males 18 years or older who are undergoing elective vasectomy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediate pre-operative period

Awards & highlights

Study Summary

This trial will test if a VR headset can reduce pain and anxiety in vasectomy patients. The headset is currently being studied to be approved by the FDA.

Who is the study for?

This trial is for adult men over 18 who are having a vasectomy and don't have serious illnesses that could affect their safety or ability to complete the study. It's not for those with major vision problems, epilepsy, skin infections, cancer, chronic pain disorders, or habitual narcotic use.Check my eligibility

What is being tested?

The study tests if a VR headset called SmileyScope can lessen pain and anxiety during vasectomy. The device isn't FDA-approved yet for this use; it's under review for reducing discomfort in younger patients during needle procedures.See study design

What are the potential side effects?

Since the intervention involves non-invasive VR technology, side effects may be minimal but could include dizziness, nausea related to virtual reality sickness or discomfort from wearing the headset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult male, 18 or older, planning to have a vasectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediate post-operative period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediate post-operative period

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate post-operative period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-operative anxiety

Post-procedure satisfaction

Anxiety

+2 more

Secondary outcome measures

Heart rate

Oxygen Saturation

Physiological Intra-operative skin temperature

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Static VRExperimental Treatment1 Intervention

Patients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario.

Group II: Interactive VRExperimental Treatment1 Intervention

Patients will be wearing a virtual reality headset preloaded with an interactive VR scenario.

Group III: ControlActive Control1 Intervention

Patients will not be wearing any virtual reality headset.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

409,852 Total Patients Enrolled

1 Trials studying Postoperative Pain

84 Patients Enrolled for Postoperative Pain

Ranjith Ramasamy, MDPrincipal InvestigatorUniversity of Miami

12 Previous Clinical Trials

763 Total Patients Enrolled

Media Library

Static VR Clinical Trial Eligibility Overview. Trial Name: NCT05591274 — N/A

Postoperative Pain Research Study Groups: Static VR, Control, Interactive VR

Postoperative Pain Clinical Trial 2023: Static VR Highlights & Side Effects. Trial Name: NCT05591274 — N/A

Static VR 2023 Treatment Timeline for Medical Study. Trial Name: NCT05591274 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for participants in this research endeavor?

"Confirmed, according to the clinicaltrials.gov listing this study is still open for recruitment of participants. It was first announced on November 17th 2022 and its details were updated as recently as November 21st 2022."

Answered by AI

What are the underlying aims of this research endeavor?

"The primary endpoint of this trial is the Subjective Pre-operative pain, which will be measured during an initial timeframe. Secondary endpoints include Physiological Post-operative heart rate (measured via FitBit Versa 3 device on patient's wrist), Physiological Post-operative skin temperature (also measured by a FitBit Versa 3 worn at the patient's wrist) as well as Intra-operative skin temperature (likewise taken with a FitBit Versa 3)."

Answered by AI

What is the capacity of this research program's participant pool?

"Affirmative. Clinicaltrials.gov reveals that this research project, which was first posted on November 17th 2022, is actively recruiting participants. 164 individuals must be enrolled from 1 clinic site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality Technology for Vasectomy Pain Modulation

Ranjith Ramasamy, MD 2022. "Virtual Reality Technology for Vasectomy Pain Modulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05591274.