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Clinical Trial

Use of VR for Diagnostic Hysteroscopy

NCT: NCT07173231 · RECRUITING

NCT IDNCT07173231
StatusRECRUITING
Start Date2026-07-08
Completion2027-07
SponsorSt. Justine's Hospital (OTHER)
First posted
Last updated

Brief Summary

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

Frequently Asked Questions

What is Use of VR for Diagnostic Hysteroscopy?

Use of VR for Diagnostic Hysteroscopy is a clinical trial registered under NCT07173231. Current status: RECRUITING.

What is the status of NCT07173231?

The current status of NCT07173231 (Use of VR for Diagnostic Hysteroscopy) is: RECRUITING.

When did Use of VR for Diagnostic Hysteroscopy start?

Use of VR for Diagnostic Hysteroscopy started on 2026-07-08.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.