A Study of Virtual Reality During Urological Procedures

Study Overview
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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.

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.

Official Title
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Impact of Virtual Reality on Patient Vital Signs During Urological Bedside Vasectomies

Conditions
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Healthy

Intervention / Treatment
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* Other: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Any patient undergoing a vasectomy, transrectal prostate biopsy, cystoscopy, Doppler ultrasound, or Xiaflex. Exclusion Criteria: - Anyone < 18 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Group<br>Subjects will wear a virtual reality headset during their urological bedside vasectomy. | Other: Virtual Reality<br>* 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<br>|
| No Intervention: Standard of Care Group<br>Subjects will undergo standard of care urological bedside vasectomy | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | 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 | Post-procedure (approximately 1 hour) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Vasectomy Procedure