Virtual Reality for Urological Procedures

NCT06534086 | Completed

• 1 other identifier: HS26202
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

feasibility; virtual reality; perioperative mental health

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Proportion of individuals who consent to participation and the number of recruited participants per week

  through study completion, up to 1 year

• Inclusion criteria and demographic and surgery-related differences

  Proportion of individuals who meet inclusion criteria and any demographic and surgery-related differences in potentially eligible participants

  through study completion, up to 1 year

• Retention of participants in the study

  Proportion of individuals who tolerate the intervention and complete the study

  Immediate post-operative

• Acceptability through elevate scores on the Virtual Reality Impression Scale

  Acceptability of the VR program during urological procedures (0 thru 100, 100=positive impressions)

  Immediate post-operative

• Impressions of the VR based on open-ended responses on the Virtual Reality Impression Scale

  Negative and positive impressions of the VR intervention (open ended/qualitative)

  Immediate post-operative

Secondary Outcomes (9)

• Scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (and adapted Anxiety Thermometer)

  Pre-operative, acute post-operative (immediately following surgery)

• Visual Analogue Scale pain severity

  Peri-operative (mid-way through procedure)

• Visual Analogue Scale anxiety severity

  Peri-operative (mid-way through procedure)

• State Trait Anxiety Inventory (STAI) elevated scores

  Pre-operative, acute post-operative (immediately following surgery)

• PROMIS Pain Intensity Scale total score

  Acute post-operative (immediately following surgery)

Study Arms (4)

Cystoscopy VR intervention

EXPERIMENTAL

Local anesthetic and VR intervention

Device: Virtual reality (VR) guided meditation therapy

Cystoscopy treatment as usual

ACTIVE COMPARATOR

Local anesthetic only

Other: Treatment as usual

Vasectomy VR intervention

EXPERIMENTAL

Local anesthetic and VR intervention

Device: Virtual reality (VR) guided meditation therapy

Vasectomy treatment as usual

ACTIVE COMPARATOR

Local anesthetic only

Other: Treatment as usual

Interventions

Virtual reality (VR) guided meditation therapy DEVICE

Tripp application on Meta Quest 3 VR headset

Cystoscopy VR intervention; Vasectomy VR intervention

Treatment as usual OTHER

No VR, local anesthetic only

Cystoscopy treatment as usual; Vasectomy treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Men's Health Clinic

Winnipeg, Manitoba, R3P 2S8, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain; Patient Satisfaction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Renée El-Gabalawy, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Premal Patel, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Simone Gentile, BSc

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Other = feasibility (primary) + clinical pilot outcomes (secondary)

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: August 2, 2024
• Study Start: June 6, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 23, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)