Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2025-11-30
2026-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Immersive Virtual Reality Distraction (IVR)
Use of IVR during diagnostic hysteroscopy
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.
Hypno-Virtual Reality distraction (HVR)
Use of HVR during diagnostic hysteroscopy
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.
Usual Care Treatment
Standard protocol offered at CHU Ste-Justine's Hospital before a diagnostic hysteroscopy procedure
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Speak and read French or English
* Scheduled to undergo a diagnostic hysteroscopy
Exclusion Criteria
* Recent ophthalmologic surgery (\< 1month) or any ophtalmologic problems that could interfere with the patient's ability to use the VR technology
18 Years
FEMALE
No
Sponsors
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St. Justine's Hospital
OTHER
Responsible Party
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Sylvie Le May
Principal investigator
Principal Investigators
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Sylvie Le May PhD
Role: PRINCIPAL_INVESTIGATOR
St. Justine's Hospital
Central Contacts
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References
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Other Identifiers
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VR-HYSTERO
Identifier Type: -
Identifier Source: org_study_id
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