Virtual Reality for Urological Procedures

University of Manitoba

Status: Completed

Conditions: Feasibility; Pain; Satisfaction, Patient; Anxiety State

Treatments: Other: Treatment as usual; Device: Virtual reality (VR) guided meditation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06534086

HS26202

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Cystoscopy VR intervention

Experimental group

Description:

Local anesthetic and VR intervention

Treatment:

Device: Virtual reality (VR) guided meditation therapy

Cystoscopy treatment as usual

Active Comparator group

Description:

Local anesthetic only

Treatment:

Other: Treatment as usual

Vasectomy VR intervention

Experimental group

Description:

Local anesthetic and VR intervention

Treatment:

Device: Virtual reality (VR) guided meditation therapy

Vasectomy treatment as usual

Active Comparator group

Description:

Local anesthetic only

Treatment:

Other: Treatment as usual