A Study of Virtual Reality During Urological Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2024-10-01

Brief Summary

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This research is being done to see if virtual reality devices are able to distract patients during Urologic beside vasectomy procedures in the clinic and help improve patient experience and vital signs.

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Detailed Description

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Once participants are consented and checked in for the procedure, researchers will obtain the randomization assignment from a REDCap database with a randomization module designed by the study statistician. Participants will be randomized in a 1:1 ratio to either virtual reality or standard of care.

Researchers will collect participant vital signs (heart rate, blood pressure, and SpO2) at check in, laying down on the table, in the midst of the procedure, and after the procedure is complete. After the procedure is completed, all participants will be given two surveys about satisfaction with the experience to complete. Researchers will record any medications the participants takes the day of the procedure. Researchers will then gather demographic data from the participant's chart through Epic (age, height, weight, BMI, race, ethnicity, past medical history, and procedure information). All study data will be stored in a secure REDcap database. Researchers have teamed up with members of the anesthesia department at Mayo Clinic Florida who have performed similar studies utilizing the virtual reality headsets. The department has three virtual reality headsets and know how to operate them.

The participants who are selected to use the virtual reality device will be viewing calming narrated scenarios with relaxing music of walking through a forest, along a beach, through a chinese garden, a winter landscape or taking off in a spaceship or snorkeling through a reef.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Virtual Reality Group

Subjects will wear a virtual reality headset during their urological bedside vasectomy.

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type OTHER

Virtual reality device will be viewing calming narrated scenarios with relaxing music of walking through a forest, along a beach, through a Chinese garden, a winter landscape or taking off in a spaceship or snorkeling through a reef

Standard of Care Group

Subjects will undergo standard of care urological bedside vasectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality

Virtual reality device will be viewing calming narrated scenarios with relaxing music of walking through a forest, along a beach, through a Chinese garden, a winter landscape or taking off in a spaceship or snorkeling through a reef

Intervention Type OTHER