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Use of VR for Diagnostic Hysteroscopy

Study acronym: VR-HYSTERO
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Mar 2026 → May 2027
See other at-risk trials from St. Justine's Hospital

Record History

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  1. Notable Primary completion pushed from Mar 2026 to May 2027 Show 9 more changesShow less
    • Recruitment opened
    • Lead sponsor: St. Justine's Hospital to St. Justine's Hospital
    • Start date changed from estimate of Nov 2025 to Jul 8, 2026
    • Primary endpoints: details revised at 3 of 5 entries
    • Study completion pushed from Mar 2026 to Jul 2027
    • Study sites: 0 to 1
    • Secondary endpoints: 6 to 5
    • Publications: details revised at 28 of 28 entries
    • Eligibility criteria expanded, about 5 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
3,263 trials monitored
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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
Trial Details
NCT Number NCT07173231
Lead Sponsor St. Justine's Hospital
Conditions
(from sponsor)
Hysteroscopy, Anxiety, Pain
Related terms Anxiety Disorders, Pain, Procedural Pain
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov