Anxiety State, Feasibility, Pain, Satisfaction, Patient
Conditions
Keywords
feasibility, virtual reality, perioperative mental health
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.
Interventions
Tripp application on Meta Quest 3 VR headset
OTHERTreatment as usual
No VR, local anesthetic only
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Other = feasibility (primary) + clinical pilot outcomes (secondary)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Retention of participants in the study | Immediate post-operative | Proportion of individuals who tolerate the intervention and complete the study |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| Satisfaction With Surgery score | Acute post-operative (immediately following surgery) | Item to assess overall satisfaction with surgery (0 thru 10, 10=greater satisfaction) |
| 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 |
| 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 |
| Selection of VR experience | Pre-operative | What Tripp experience that participants select (out of 5 potential programs) |
| 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 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) |
| 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) |
Countries
Canada
Outcome results
None listed