Virtual Reality for Urological Procedures

Not Applicable

Completed

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

• Registration Number: NCT06534086
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-06
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-31
• Status Verified: 2024-08
• Study First Posted: 2024-08-02
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability through elevate scores on the Virtual Reality Impression Scale	Immediate post-operative	Acceptability of the VR program during urological procedures (0 thru 100, 100=positive impressions)
Inclusion criteria and demographic and surgery-related differences	through study completion, up to 1 year	Proportion of individuals who meet inclusion criteria and any demographic and surgery-related differences in potentially eligible participants
Impressions of the VR based on open-ended responses on the Virtual Reality Impression Scale	Immediate post-operative	Negative and positive impressions of the VR intervention (open ended/qualitative)
Recruitment rate	through study completion, up to 1 year	Proportion of individuals who consent to participation and the number of recruited participants per week
Retention of participants in the study	Immediate post-operative	Proportion of individuals who tolerate the intervention and complete the study

Secondary Outcome Measures

Name	Time	Method
Subjective assessment of time spent in VR vs. actual time in VR	Evaluated immediate post-operative	Perception of time during procedure compared to actual time among those in VR
Scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (and adapted Anxiety Thermometer)	Pre-operative, acute post-operative (immediately following surgery)	Brief self-report visual analogue scales (VAS) for anxiety/distress (0 thru 10, 10=worse anxiety/distress)
Visual Analogue Scale anxiety severity	Peri-operative (mid-way through procedure)	Brief self-report visual analogue scales (VAS) for acute anxiety (0 thru 10, 10=more severe anxiety)
PROMIS Pain Intensity Scale total score	Acute post-operative (immediately following surgery)	Brief self-report questionnaire with questions surrounding experienced pain (3 thru 15, 15=greater pain severity)
Visual Analogue Scale pain severity	Peri-operative (mid-way through procedure)	Brief self-report visual analogue scales (VAS) for acute pain (o thru 10, 10=more severe pain)
i-Group Presence Questionnaire (IPQ) score	Acute post-operative (immediately following surgery)	Brief self-report questionnaire with questions surrounding VR experience (spatial presence, involvement, experience realism), higher scores=greater presence
State Trait Anxiety Inventory (STAI) elevated scores	Pre-operative, acute post-operative (immediately following surgery)	Brief self-report questionnaire with questions surrounding anxiety traits (0 thru 63, higher score=more severe anxiety)
Satisfaction With Surgery score	Acute post-operative (immediately following surgery)	Item to assess overall satisfaction with surgery (0 thru 10, 10=greater satisfaction)
Selection of VR experience	Pre-operative	What Tripp experience that participants select (out of 5 potential programs)

Trial Locations

Locations (1)

Men's Health Clinic; 🇨🇦 Winnipeg, Manitoba, Canada