Virtual Reality for Urological Procedures
NCT Number: NCT06534086
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Feasibility|Anxiety State|Pain|Satisfaction, Patient
Interventions: DEVICE: Virtual reality (VR) guided meditation therapy|OTHER: Treatment as usual
Sponsor: University of Manitoba
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-06
Completion Date: 2024-11-01
Locations: Men's Health Clinic, Winnipeg, Manitoba, R3P 2S8, Canada

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.

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