A Study of Virtual Reality During Urological Procedures

Not Applicable

Withdrawn

• Conditions: Healthy
• Interventions: Other: Virtual Reality

• Registration Number: NCT05570214
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-06
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Any patient undergoing a vasectomy, transrectal prostate biopsy, cystoscopy, Doppler ultrasound, or Xiaflex.

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Exclusion Criteria

• Anyone < 18 years of age.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Group	Virtual Reality	Subjects will wear a virtual reality headset during their urological bedside vasectomy.

Primary Outcome Measures

Name	Time	Method
Change in heart rate	Baseline, intra-procedure, post-procedure (approximately 1 hour)	Number of beats per minute
Change in Systolic blood pressure	Baseline, intra-procedure, post-procedure (approximately 1 hour)	Measured in millimeters of mercury (mmHg)
Change in diastolic blood pressure	Baseline, intra-procedure, post-procedure (approximately 1 hour)	Measured in millimeters of mercury (mmHg)
Change in oxygen saturation levels	Baseline, intra-procedure, post-procedure (approximately 1 hour)	Measured by a pulse oximeter reading reported as a percentage

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	Post-procedure (approximately 1 hour)	Measured using the self-reported QoR-15 patient survey. 15-item questionnaire used to assess feelings and pain within the last 24 hours on a scale from 0 to 10; 0 indicating none of the time \[poor\] and 10 indicating all of the time \[excellent\]. Higher total scores indicate greater patient satisfaction

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States