NCT05570214

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
2 years until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

Same day

First QC Date

October 4, 2022

Last Update Submit

October 18, 2024

Conditions

Healthy

Keywords

Virtual RealityVasectomy Procedure

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Patient satisfaction

    Post-procedure (approximately 1 hour)

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Other: Virtual Reality

Standard of Care Group

NO INTERVENTION

Subjects will undergo standard of care urological bedside vasectomy

Interventions

Virtual RealityOTHER

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

Virtual Reality Group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- Anyone \< 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

Study Officials

  • David Thiel, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 6, 2022

Study Start

October 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)