Virtual Reality for Urological Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-06

Study Completion Date

2024-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Feasibility Anxiety State Pain Satisfaction, Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Other = feasibility (primary) + clinical pilot outcomes (secondary)

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cystoscopy VR intervention

Local anesthetic and VR intervention

Group Type EXPERIMENTAL

Virtual reality (VR) guided meditation therapy

Intervention Type DEVICE

Tripp application on Meta Quest 3 VR headset

Cystoscopy treatment as usual

Local anesthetic only

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

No VR, local anesthetic only

Vasectomy VR intervention

Local anesthetic and VR intervention

Group Type EXPERIMENTAL

Virtual reality (VR) guided meditation therapy

Intervention Type DEVICE

Tripp application on Meta Quest 3 VR headset

Vasectomy treatment as usual

Local anesthetic only

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

No VR, local anesthetic only

Interventions

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Virtual reality (VR) guided meditation therapy

Tripp application on Meta Quest 3 VR headset

Intervention Type DEVICE

Treatment as usual

No VR, local anesthetic only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* can speak and read English
* have an indication for a cystoscopy or elected for a vasectomy
* are scheduled to undergo their respective procedure under local anesthesia at the Men's Health Clinic between the dates of May-November 2024.

Exclusion Criteria

* those who are not competent to provide informed consent (e.g., due to cognitive impairment)
* those who are unable to participate in a VR intervention (e.g., due to visual or auditory impairment)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes