Interest of Virtual Reality Headset During Injection in Patients With Back Pain and Sciatica
Condition: Lumbar Radicular Pain
Study type: Interventional

Summary: 
      For a few years, publications have been published concerning the use of virtual reality
      headsets in the field of medicine and particularly in various specialities.

      It has been evaluated in different studies on pain and anxiety in various medical situations.

      A study has shown a correlation between a decrease in pain in a clinical way during a painful
      stimulation and a decrease in certain areas of the brain.

      In this context, the use of the virtual reality headset could then be used in medical
      interventions that may be painful for the patient.

      The lumbar radicular pain is a common disease in the world. The epidural injection is one of
      the treatment of this pathology. He may be performed to reduce the pain but sometimes this
      act is painful. Most of the time this procedure is performed without premedication.

      To the knowledge of the investigators, there are currently no studies on the assessment of
      pain under a virtual reality headset during the performance of an epidural injection in
      rheumatology.

      The aim of the study is to demonstrate that the Virtual Reality Headset can reduce the pain
      and the anxiety during an epidural injection.
    

Detailed description: 
      Any patient who meets the inclusion criteria can be offered this study. The physician will
      verify with the data collected during the usual management of the patient whether the patient
      presents the inclusion criteria and no exclusion criteria. The questioning (history of the
      disease, treatments, etc.) and the clinical examination will be carried out within the
      framework of the usual management of the patient before his inclusion in the study.

      After the patient's agreement and signature of the consent form, the patient will be
      randomized in one of the two groups :

        -  Group 1: Use of the virtual reality headset during the first epidural infiltration. The
           second infiltration will be performed without the virtual reality headset.

        -  Group 2: First epidural infiltration without the virtual reality headset. The second
           infiltration will be performed with the virtual reality headset.

      The duration of participation in each of the two groups is 3 days:

      - On the 1st day, the patients will have to fill in a questionnaire with socio-demographic
      data, pain related to the disease, their anxiety in general life, their anxiety before the
      infiltration.

      The patient will choose, with the help of the doctor, the landscape that will be projected in
      the virtual reality headset, and then the helmet will be put in place, again with the help of
      the doctor.

      Concerning the installation, the patient will be in prone position with the hands under the
      chin with the reality headset so that he cannot rest on the bed. The patient must be
      comfortable.

      The first epidural infiltration will be performed with or without the virtual reality headset
      depending on the randomization group.

      Then the patient will have to estimate his pain thanks to the numerical scale as well as his
      state of anxiety during the procedure. This part of the questionnaire will be completed after
      the first infiltration.

        -  On the 2nd day, there will be no infiltration and no questionnaire to fill in.

        -  On the 3rd day, the second epidural infiltration will be performed with or without
           virtual reality headset depending on the randomization group. Patients will be asked to
           fill in their anxiety status before the procedure, their pain during the procedure and
           the estimated anxiety during the procedure.

      Both infiltrations will be performed by a person trained and experienced in performing
      infiltrations through the hiatus route.

      The virtual reality headset used is provided by the company Healthy Mind and corresponds to a
      class 1 CE medical device. This virtual reality headset is a Pico G2 4K and corresponds to
      the model A7510 and is connected to a Bose Sound Link 2 AE headset, all connected to a tablet
      allowing to control the chosen universe.

      There will be no remote monitoring of the patient.
    

Intervention name(s): Virtual Reality Headset
Intervention type(s): Other
Intervention description(s): Virtual Reality Headset of the society Healthy Mind and is a CE Class 1 medical device. This virtual reality headset is a Pico G2 4K and corresponds to the model A7510 and is connected to a Bose Sound Link 2 AE headset.
Other intervention name(s): Medical device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention