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HypnoVR

By HypnoVR

HypnoVR is a virtual reality hypnosis solution intended to improve management of patients’ pain, stress and anxiety by providing an alternative or complementary solution to chemical treatments.

Level 1

I am a CE-certified medical device

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General description
Additional info
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General description (provided by company)

Main purpose

HypnoVR is a virtual reality (VR) hypnosis solution intended to improve management of patients’ pain, stress and anxiety by providing an alternative or complementary solution to chemical treatments.

Stress and anxiety occur in 60 to 80% of hospitalized patients. These two conditions favour postoperative complications, pain, medications and increase the length of stay in the hospital (Stamenkovic 2018 , Kain 2006 ).
Over 300 million of surgeries are performed each year (Meara 2015 ), these may lead to postoperative pain. It is recommended to add a non-pharmacological pain management modality in the treatment (Joint Commission ).
Medical hypnosis and VR are effective tools for the management of preoperative anxiety as well as acute pain (Guegen 2005 , Eijlers 2019 , Mallari 2019 , Patterson 2007 ) and decrease opioid use during painful procedures (Garland 2017 , Das 2005 ).
HypnoVR combines hypnosis and VR to cumulate the benefits of the two techniques and focus on their complementarity. HypnoVR’s unique medical hypnosis software combines immersive virtual worlds, musicotherapy as well as hypnotic suggestions in a highly personalize experience delivered through virtual reality headsets which guides the patient and improves patient anxiety and pain before, during or after a medical procedure

Target audience

All patients older than 7 years old subject to stress, pain, anxiety encountered before, during or after a medical procedure.

Approach

HypnoVR is a medical hypnosis solution using VR for the treatment of pain, stress and anxiety. It is a simple non-chemical alternative for patients and caregivers. The app has been developed by Healthcare professionals with over 20 years of experience using clinical hypnosis in a peri-operative context.
Within each HypnoVR session, only usage data is collected, for example: length of session, number of sessions and content experienced. There is no personal data gathered. Healthcare professionals have access to usage data in their secure customer portal to follow treatments realized with HypnoVR solution.

Connectivity to sensors and platforms

HypnoVR device is supplied ready to use, without the need for a connection. Wifi connection is only required to have the updates and the remote maintenance.
Bluetooth: The healthcare professional pairs the VR headset with the Compagnon mobile device application (Bluetooth connection required).

Financing and pricing model

Subscription based business model:
We offer HypnoVR’s solution through a comprehensive subscription which includes:
- HypnoVR’s software medical device license (with unlimited usage and all scenarios) including software update + maintenance
- VR headset with extended guarantee
- Replacement of the VR headset after 2 years (to take advantage of new headset technologies)
- Noise cancelling headphones
- Companion mobile device application
- Tablet (for companion mobile application) with extended guarantee
Fees are charged to the health care facility.

Acquisition based business model:
We also offer HypnoVR’s solution as a one-time acquisition which includes:
- Software medical device acquisition (with unlimited usage and all scenarios) with software update during 2 years + maintenance during 2 years
- VR headset with VR manufacturer guarantee
- Noise cancelling headphones
- Companion mobile device application
- Tablet (for companion mobile application) with manufacturer guarantee

Pathology

Brain / Nerves Cancer Chest / Lung Dental Diabetes Ear / Nose / Throat Gastrointestinal Heart / Blood Vessels Kidney / Genito-urinary Other Pain Pregnancy Rehabilitation Skin Treatment adherence

Functions

Treatment Support

Users

Clinicians

Additional info

Compliance to M1 criteria

CE certification

Download document Granted by HypnoVR (Self declaration) Assessed and certified meeting the requirements of:
Medical Device Directive: MDD 93/42/EEC (old regulation) Medical Device Regulation: MDR 2017/745 (new regulation) In Vitro Diagnostic Directive: 98/79/EC (old regulation) In Vitro Diagnostic Regulation: IVDR 2017/746 (new regulation)
Certificate granted on 25/11/2022 Certificate valid till 31/12/2028 Class type of medical device (More info): 1
ISO Standards:
ISO 13485 Quality Management Systems for Medical Devices (on company level) ISO 14155 Clinical Investigations of Medical Devices in Human Subjects ISO 14971 Risk Management of Medical Devices ISO 27000 series: Information Security Management Systems ISO 62304 Medical Device Software Lifecycle Processes ISO 62366 Application of Usability Engineering to Medical Devices

FAMHP registration and notification

Company registration number at FAMHP: 72948 Product identification code at FAMHP: 648262

General Data Protection Regulation (More info)

Company declares explicitly to be compliant with GDPR rules Company declares that the data are stored in EU only

The app is only available through prescription

Reference publication

International VR Research
Randomized trials has shown that hypnosis reduces the amount of analgesics and/or sedatives administered intraoperative in surgery and interventional medicine (Valentine 2019 , Kendrick 2015 , Thompson 2010 ). Hypnosis is shown to reduce anxiety, acute and chronic pain (Gueguen 2015 ). VR is quickly emerging in the medical space with a wide array of application (Gold 2005). Recent randomized studies have shown that virtual reality is effective in minimizing stress prior to surgery in adults and children (Bekelis 2017 , Ryu 2017 ). Immersive VR can help significantly reduce pain, anxiety and discomfort for patient with various conditions (anesthesia, algology, oncology) in adults and children (Eijlers 2019 , Mallari 2019 , Ahmadpour 2020 , Chan 2018 , Chen 2020 , Patterson 2021 ). Virtual reality also appears to be a non-opioid treatment for chronic pain (Jensen and Patterson 2014 , Darnall 2020 ) and reduced anxiety and pain in hospitalized patients (Mosadeghi 2016 , Tashjian 2017 , Jones 2016 ). Immersion in VR can isolate the patient from the outside environment, and it is effective in distracting the subject’s attention from a painful stimulus (Patterson 2006 ). VR has been shown to divert attention from painful stimulation in both highly hypnotizable and less hypnotizable individuals in experimental and clinical settings (Tashjian 201725, Enea 2014 ).
Hypno VR medical expertise
Dr Denis Graff et Dr Chloé Chauvin (co-founders of HypnoVR), anesthesiologists and hypnotherapists bring their expertise for the implementation of clinical studies and for the construction of medical hypnosis scenarios. HypnoVR company has an international scientific board composed by medical experts: Pr Pierre Diemunsch (Department of Anesthesiology, University of Strasbourg (France), Pr Tong Joo Gan (Chairman, Department of Anesthesiology, Stony Brook University Renaissance School of Medicine, New-York (USA)), Pr Peter Kranke (department of anesthesiology, University of Wurzburg, Germany), Dr Klaus Torp (department of Anesthesiology, Mayo Clinic, Jacksonville, in Florida (USA)), Pr Olivier Traxer (department of Urology, Sorbonne University (Paris-France)).

User instructions

The HypnoVR solution is a stand-alone software running on a mobile VR headset and controlled via a Compagnon mobile applications (iOS/Android) to control and spectate the HypnoVR session.
The clinician creates a scenario based on environment patient choice. Several parameters can be selected according to the medical procedure either by the patient (voice, music atmosphere and visual environment) or the healthcare professional (duration, hypnotic narratives).
Software has been designed to be as simple as possible and accessible to all. The solution can be launched in less than 30 seconds, which proves its effectiveness and ease of use.
Several tutorials for installation and use are available on the HypnoVR website. A tutorial video is accessible in the authentication page. A remote customer support is also available on the website (phone number and email).

Components of the application

Medical device

Complaints handling

Via e-mail: hello@hypnovr.ioVia telephone: +33 3 73 80 00 33

Media

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