Revolutionising medicine with technology: HypnoVR’s journey towards clinical validation of its digital therapies

HypnoVR, a pioneer in medical innovation, is revolutionising the treatment of pain and anxiety with its digital therapies. Clinical validation of new immersive technologies is at the heart of HypnoVR’s DNA. Let’s explore together how to meet the unique challenges of this fast-moving sector.

From the importance of adherence to medical standards to adaptability to practical needs, in this article we retrace HypnoVR’s journey, from its initial ambition to be recognised as a medical device to the completion of large-scale clinical studies validating the effectiveness of HypnoVR’s digital therapy.

Explore HypnoVR’s journey through observational studies, user feedback and randomised clinical trials, demonstrating the effectiveness and safety of its solutions.

A clinical strategy guided by the desire to be a medical device

From the outset, HypnoVR’s objective was ambitious: to transform an idea – to make medical hypnosis accessible to everyone – into a recognised technological innovation and, above all, into a certified medical device. This vision led us to work closely with experts in medical device regulation, a fruitful partnership that resulted in HypnoVR being classified as a Class I medical device. This class of medical device corresponds to devices that present a minimal risk to patients, but also guarantee their safety through the implementation of a quality management system. This classification has enabled HypnoVR to be adopted by healthcare institutions, while at the same time developing a short- and long-term clinical validation strategy.

From concept to clinically validated device


At the start of HypnoVR, to guide us in our choices and validate the effectiveness of the solution, we drew on existing research on hypnosis, virtual reality and music therapy. Each of these techniques showed interesting results, independently, in reducing pain and anxiety.

For example, we drew on information from studies carried out by Hoffmann’s team in the United States, which demonstrated the effectiveness of virtual reality hypnosis on burn patients. As virtual reality is first and foremost a technological means of immersing the patient, the therapeutic experience and its effectiveness depend on the psychological mechanisms involved. We quickly realised that we needed to demonstrate the safety and efficacy of our specific combination of these three techniques in a clinical setting.

Feedback from the field and feasibility studies to demonstrate safety and effectiveness

The first stage of our exploration was to gather feedback from the first users. Using our own questionnaires, we were able to gain a better understanding of the use, satisfaction and effectiveness of the solution, from the point of view of both patients and carers.

To demonstrate that the use of HypnoVR was both feasible and safe on a large scale, we set up feasibility studies, drawing on the skills of HypnoVR’s collaborators, in particular Dr Chloé CHAUVIN. These studies led to our first communications, in the form of posters or presentations at medical conferences. Several parameters were examined, such as pain, anxiety and patient satisfaction, as well as ease of use and compatibility with medical procedures for carers.

These feasibility studies have covered a wide range of medical fields, from surgery to dentistry, from pre-operative to post-operative. Their results confirmed the safety and performance of our device and met the requirements of Regulation (EU) 2017/745 on medical devices, but also enriched our understanding of its practical application. We have begun to see very good results in terms of therapeutic effectiveness, such as a 45% reduction in pre-operative anxiety in dental surgery and a 40% reduction in post-operative pain in scoliosis surgery.

These results have enabled us to refine our recommendations for the use of HypnoVR. We quickly discovered the constraints and limitations associated with certain indications, which led us to adapt our digital therapy and the solution’s use cases to best meet the needs and expectations of healthcare professionals and their patients.

For example, one study showed that the use of HypnoVR was more relevant and appreciated before an oocyte puncture than during the procedure itself ( During the puncture, many women preferred to observe the monitoring of the procedure rather than being immersed in a virtual reality experience.

Dental care, which is an ideal indication for HypnoVR, with 1 in 2 patients subject to anxiety (Pratiques dentaires, UFSBD June 2013; 20-23) has also shown limitations in use. While studies and user feedback have confirmed the effectiveness of HypnoVR in reducing anxiety before and during dental treatment, the size of the virtual reality headset has long been a hindrance to many dentists during treatment. That’s why HypnoVR is developing a specific version of its solution on an HTC ViveFlow headset that is much more compact and compatible with the dentist’s technical movements.

Randomised studies to demonstrate performance and non-randomised studies to better understand impact and use

The transition to randomised controlled trials was a crucial step. By comparing the use of HypnoVR with standard practice, these studies aim to demonstrate indisputably its effectiveness in reducing pain and anxiety, while minimising bias as far as possible.


use of tier 3 painkillers

22. Anxiety management for outpatient Hallux Valgus surgery …

Hôpital Ambroise Paré (AP-HP)



18. Perioperative results of immersive virtual reality as an adjuvant to surgical

Mayo Clinic – Floride

Randomised controlled trials (RCTs) are essential for evaluating the effectiveness of medical treatments, but their applicability in real clinical practice may be limited. Observational studies complement RCTs by providing insights into the real world and extending understanding of medical interventions. Together, these two methods provide a comprehensive and informed perspective for clinical decision-making.

While randomised trials are our priority today, we are also continuing observational studies to confirm the value of HypnoVR in new medical indications.

Feedback on our clinical validation process

Our journey has been a rich learning experience, with successes and challenges that we want to share.

Validating HypnoVR in different indications

We began our clinical career in anaesthesia, in the operating theatre, for two essential reasons: the expertise of our co-founding anaesthetists (Dr Chloé Chauvin & Dr Denis Graff) in this speciality and the desire to validate the effectiveness of HypnoVR in particularly painful and anxiety-provoking situations.

For example, we explored the use of HypnoVR in scoliosis surgery and hip arthroplasty at a very early stage. These initial validations have paved the way for the validation of other medical specialities, including dentistry, gynaecology, oncology, urology and emergency services for both adults and children.

A hybrid clinical strategy for HypnoVR

Maintaining a dual approach of feasibility studies and randomised trials in our clinical validation was a wise decision.

The feasibility studies, although limited in their ability to provide detailed conclusions, especially in the absence of a control group, were crucial in providing us with a large amount of data quickly. These results enabled us to adjust the development of our solution very early on.

At the same time, randomised studies, despite their greater demands on time and energy, offered a much higher level of detail and rigour. The challenges associated with these studies, such as the long lead times for preparation, patient recruitment and publication, were offset by the quality and accuracy of the information gathered. In addition, the increased visibility afforded by the publications resulting from these randomised trials has greatly enhanced the value of our work.

The combination of these two approaches enabled us to effectively balance the speed of data collection with the depth and reliability of the results obtained.

Clinical studies at HypnoVR today

Following the acquisition of Oncomfort, HypnoVR now has almost 50 scientific communications, including 15 publications. Of these, 25 are randomised controlled trials in various fields.

We are continuing to conduct randomised controlled trials, mainly in new areas such as pre-operative care, pre-delivery labour and palliative care. In addition, we are encouraging studies focusing on medico-economic objectives to assess the impact of HypnoVR in the context of healthcare costs.

This clinical validation process is part of our scientific DNA and plays a key role in our ongoing commitment to provide solid, objective evidence of HypnoVR’s efficacy and safety.

Don’t hesitate to contact us if you have any subjects you’d like to study. We’d be delighted to help you.

Coralie Gianesini
R&D Engineer at HypnoVR

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