A Study of Virtual Reality During Urological Procedures

Mayo Clinic

Status: Withdrawn

Conditions: Healthy

Treatments: Other: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT05570214

22-000947

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Anyone < 18 years of age.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Virtual Reality Group

Experimental group

Description:

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

Treatment:

Other: Virtual Reality

Standard of Care Group

No Intervention group

Description:

Subjects will undergo standard of care urological bedside vasectomy