Use of VR for Diagnostic Hysteroscopy

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. VR has shown potential in reducing pain and anxiety during medical procedures, and its combination with hypnosis may offer enhanced benefits, though current evidence is limited.

Objective: This pilot study aims to assess the effectiveness of immersive virtual reality (IVR) and Hypno-VR (HVR) in managing pain and anxiety during diagnostic HSC and to evaluate the feasibility and acceptability of both IVR and HVR interventions in an outpatient clinical setting.

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

Conditions

• Hysteroscopy
• Anxiety
• Pain

Interventions

DEVICE

Immersive Virtual Reality Distraction (IVR)

The first experimental group will receive the INSPIRE® IVR intervention in addition to usual care. Developed by Paperplane Therapeutics®, INSPIRE® is specifically designed to help manage pain and anxiety in clinical settings. This intervention integrates immersive virtual environments with sensor-guided deep breathing techniques to engage the parasympathetic nervous system and promote relaxation. Within a calming forest environment, participants are guided to synchronize their breathing with the movement of a feather, encouraging breath control and relaxation. The immersive experience is enhanced through personalized therapeutic content and calming visual and auditory stimuli, helping to reduce anxiety while minimizing the risk of cybersickness. This program has been endorsed by a multidisciplinary team of healthcare professionals.

DEVICE

Hypno-Virtual Reality Distraction (HVR)

The second experimental group will receive the HVR intervention in addition to usual care. This intervention, developed by HypnoVR, consists of a VR visual scenario combined with hypnotic verbal guidance specifically designed to reduce pain and anxiety during medical procedures. It is delivered through a validated and clinically approved HVR headset. The intervention includes reassuring and calming verbal suggestions aimed at helping participants regulate their emotions and manage anxiety throughout the procedure. Participants will be able to choose from 11 different visual scenarios, select their preferred language, and choose between a male or female voice for the hypnotic guidance. 6 different musical soundtracks will also be available to personalize the experience more.

OTHER

Usual Care Group

The usual care group will only receive the standard preparation, which includes pre-treatment with Tylenol (1000mg) , Naproxen (500mg) and Ativan (1 mg) administered one hour prior to the procedure.

Sponsors & Collaborators

• St. Justine's Hospital

  lead OTHER

Principal Investigators

• Sylvie Le May PhD · St. Justine's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-30

Primary Completion

2026-03-31

Completion

2026-03-31