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Virtual Reality for Urological Procedures

NCT06534086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-23

No results posted yet for this study

Summary

It is standard practice for most cystoscopies and vasectomies in an office or outpatient setting to be performed under local anesthesia while the patient is awake and conscious. However, given the conscious nature of these procedures, patients may experience anxiety-inducing stressors that they otherwise would not under general anesthesia. Stressors such as hearing surgical terminology, technical discussion, and injection of local anesthetic have been previously documented as sources of perioperative anxiety and pain in awake surgeries.

The current study will examine the feasibility and pilot outcomes of Virtual Reality (VR) guided meditation therapy during cystoscopies and vasectomies. Feasibility will be examined through: (1) recruitment capability and resulting sample characteristics, (2) data collection procedures (including randomization) and outcome measures, and (3) participant acceptability and suitability of the VR intervention during the procedures. The investigators will also evaluate pilot outcomes of the VR intervention on pain, anxiety, and overall satisfaction with the procedure. Results of this study will inform the development of a large-scale randomized clinical trial (RCT) to evaluate the efficacy of this intervention.

Participants will be asked to complete questionnaires before and after their procedure and will be asked for a verbal measure of their pain and anxiety during the procedure.

Conditions

  • Feasibility
  • Anxiety State
  • Pain
  • Satisfaction, Patient

Interventions

DEVICE

Virtual reality (VR) guided meditation therapy

Tripp application on Meta Quest 3 VR headset

OTHER

Treatment as usual

No VR, local anesthetic only

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Renée El-Gabalawy, PhD · University of Manitoba

  • Premal Patel, MD · University of Manitoba

  • Simone Gentile, BSc · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-06
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06534086 on ClinicalTrials.gov