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Behavioural Intervention

Virtual Reality for Pain and Anxiety During Urological Procedures

N/A
Recruiting
Led By Premal Patel, MD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Have an indication for a cystoscopy or elected for a vasectomy
Must not have
Those who are not competent to provide informed consent (e.g., due to cognitive impairment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 1 year
Awards & highlights

Summary

This trial will look at using Virtual Reality (VR) guided meditation therapy for patients undergoing cystoscopies and vasectomies to reduce anxiety and pain during the procedures. The study will assess how feasible

Who is the study for?
This trial is for patients undergoing cystoscopies or vasectomies while awake, using local anesthesia. Participants should be willing to complete questionnaires and provide verbal feedback on pain and anxiety during the procedure.
What is being tested?
The study tests if VR guided meditation can help reduce stress, pain, and anxiety during urological procedures compared to usual treatment. It will also assess how easy it is to recruit participants, collect data, randomize groups, and whether people find the VR acceptable.
What are the potential side effects?
Since this trial involves non-invasive VR therapy as an intervention, side effects are minimal but may include discomfort with wearing a VR headset or dizziness from the virtual experience.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am scheduled for a bladder examination or have chosen to undergo a vasectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and consent to my own medical treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability through elevate scores on the Virtual Reality Impression Scale
Impressions of the VR based on open-ended responses on the Virtual Reality Impression Scale
Inclusion criteria and demographic and surgery-related differences
+2 more
Secondary study objectives
PROMIS Pain Intensity Scale total score
Satisfaction With Surgery score
Scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (and adapted Anxiety Thermometer)
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Vasectomy VR interventionExperimental Treatment1 Intervention
Local anesthetic and VR intervention
Group II: Cystoscopy VR interventionExperimental Treatment1 Intervention
Local anesthetic and VR intervention
Group III: Vasectomy treatment as usualActive Control1 Intervention
Local anesthetic only
Group IV: Cystoscopy treatment as usualActive Control1 Intervention
Local anesthetic only

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor
612 Previous Clinical Trials
201,454 Total Patients Enrolled
2 Trials studying Pain
60 Patients Enrolled for Pain
Premal Patel, MDPrincipal InvestigatorUniversity of Manitoba
2 Previous Clinical Trials
190 Total Patients Enrolled
Renée El-Gabalawy, PhDPrincipal InvestigatorUniversity of Manitoba
1 Previous Clinical Trials
23 Total Patients Enrolled
~25 spots leftby Nov 2024
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