Research Institute of Sant Pau begins a study that incorporates virtual reality

Research Institute of Sant Pau begins a study that incorporates virtual reality (VR) as a method of pain and anxiety reduction in gynecological procedures

Research Institute of Sant Pau begins a study that incorporates virtual reality (VR) as a method of pain and anxiety reduction in gynecological procedures

The study is the result of a collaboration agreement between the Research Institute of Sant Pau and Psious, a company specialized in Digital Therapeutics (DTX) and Virtual Reality (VR) applied to mental health.

  • The study, with 320 patient participants, will evaluate the use of VR to decrease the patient’s perception of pain and anxiety during outpatient hysteroscopy.
  • Hysteroscopy is a very common exploratory process that can lead to a sensation of self-limited but acute and uncomfortable pain in some patients.
  • The ultimate goal is to incorporate this technology to reduce the pain and/or anxiety perceived by patients during the examination and evaluate its possible application to other gynecological procedures.
  • VR has been used successfully to reduce perceived pain in various procedures such as chronic pain, burns, dental procedures, chronic pruritus, and venous puncture.

 

Barcelona, February 18, 2020. – The Institut de Recerca de la Hospital de la Santa Creu I Sant Pau – IIB Sant Pau and the digital therapeutics company, Psious, have signed a collaboration agreement in which clinical researchers from the Hospital de Sant Pau will have access to virtual reality equipment in order to carry out clinical trials with their patients. Within this collaborative framework, the duration of the VR clinical trials will last approximately 12 to 24 months, with the number of patients ranging between 200 and 300, depending on the study and covering a range of diverse pathologies.

The collaboration’s initial study is entitled, Efficacy of Virtual Reality as a Strategy of Distraction of Pain and anxiety in Hysteroscopy, led by the team of Dr. Josep Estadella, of the Gynecology and Obstetrics Service of the Hospital de Sant Pau. In the study, pain distraction environments added to traditional analgesia administered during hysteroscopy will be used, a very common exploratory process that can lead to a sensation of self-limited but acute and uncomfortable pain in some patients.

In this randomized clinical trial, 320 patients will be included in two groups: A Control group to which hysteroscopy will be practiced according to usual clinical practice and the VR group to which hysteroscopic technique will be applied by adding immersive virtual reality environment visualization, both in pre-test relaxation and during the procedure.

VR has been used successfully to reduce perceived pain in various situations such as chronic pain, burns, dental procedures, chronic pruritus, and venous puncture. The working hypothesis that is intended to be evaluated within this study is that the use of a VR device with a reproduction of relaxing and distracting environments decreases the patient’s perception of pain and anxiety during outpatient hysteroscopy.

Hysteroscopy

Hysteroscopy is a minimally invasive endoscopic technique that allows direct visualization of the uterine cavity and constitutes the “gold-standard” for the diagnosis and treatment of most intrauterine pathology, such as heavy menstrual bleeding, fibroids, endometrial polyps and uterine malformations, among others.

The technological development of the instruments has made it possible to have small-caliber endoscopic systems that allow this technique to be performed in an outpatient setting. Despite the high-resolution rates, a non-negligible percentage of women (5-10%) experience anxiety or pain during outpatient hysteroscopy. This constitutes the first cause of therapeutic failure.

In order to improve the patient’s tolerance and comfort, the usefulness of various pharmacological and non-pharmacological strategies for pain reduction has been evaluated, with diverse results.

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