Virtual Reality for Procedural Pain
(VR-HYSTERO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Background: Hysteroscopy (HSC) is a minimally invasive gynecological procedure that is considered to be the gold standard for diagnosing and treating intrauterine pathologies. In recent years, its use in outpatient settings for diagnosis has grown significantly due to its efficiency, low complication rate, and good patient acceptability. However, many patients still report significant pain and anxiety during the procedure. Despite advances in instrumentation and technique, pain remains a key reason for procedural failure, often worsened by preprocedural anxiety. While pharmacological strategies can be used to address this issue, they are not always suitable due to lack of effectiveness or feasibility. As a result, non-pharmacological approaches such as virtual reality (VR) and hypnosis are being increasingly explored.
Objective: This pilot study aims to assess the feasibility, acceptability and preliminary effects of immersive virtual reality (IVR) and Hypno-VR (HVR) in managing pain and anxiety during diagnostic HSC.
Methods: This pilot randomized controlled trial (RCT) will follow a three-arm parallel design to compare: 1- standard care, 2- IVR + standard care, and 3- HVR + standard care, during diagnostic HSC. A total of 45 participants (15/arm) will be recruited from the CHU Sainte-Justine's gynecology clinic and randomly assigned to one of the three groups. Primary outcomes will concern feasibility and acceptability including satisfaction of both patients and healthcare professionals. Secondary outcomes will assess self-reported pain and anxiety, physiological responses, procedure duration, procedure failure, and conversion rate from the "no-touch" vaginoscopy technique to traditional tools like the speculum and tenaculum. Demographic characteristics will also be explored as potential moderators of intervention effectiveness.
Results/Conclusion: This pilot study will provide preliminary data on the effects of IVR and HVR on procedural pain and anxiety during diagnostic HSC. It will also assess the feasibility and the acceptability of integrating these interventions into an outpatient setting. The findings will provide essential data in preparation for a larger clinical trial
Who Is on the Research Team?
Sylvie Le May PhD
Principal Investigator
St. Justine's Hospital
Are You a Good Fit for This Trial?
This trial is for adults (18+) who are scheduled to have a diagnostic hysteroscopy and can speak and read French or English.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Hypno-Virtual Reality Distraction (HVR)
- Immersive Virtual Reality Distraction (IVR)
Trial Overview
The study compares three approaches during hysteroscopy: standard care alone, standard care plus immersive virtual reality (IVR), and standard care plus hypno-virtual reality (HVR). Participants are randomly assigned to one of these groups.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Use of IVR during diagnostic hysteroscopy
Use of HVR during diagnostic hysteroscopy
Standard protocol offered at CHU Ste-Justine's Hospital before a diagnostic hysteroscopy procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Justine's Hospital
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.