About this trial
As a part of the current rheumatological practice skills, epidural injections through the sacrococcygeal hiatus take part in the strategy for managing radicular diseases. This technical act is easily performed in an outpatient context since it is a brief procedure, performed under clinical and ultrasound control, with good tolerance. Nevertheless, epidural injections by the way of the sacrococcygeal hiatus can be responsible of anxiety for the patient and meet the definition of pain induced by treatment. Among the non-pharmacological methods that can be offered to the patient in this context, hypnosis and distraction allow psycho-corporal support acting on certain factors influencing the painful experience of the gesture: duration of the gesture, calm and pleasant environment, etc... That is the context in which the use of virtual reality is of interest. Its use in supporting procedures generating induced pain has already been evaluated in several studies, in particular in the fields of surgery and anaesthesiology. The use of a virtual reality device also seems suitable in the context of epidural injections, but this theoretical and plausible interest remains to be demonstrated. To our knowledge, the literature on the use of a virtual reality headset to support invasive procedures in rheumatology remains poorly developed. The objective of this study is therefore to assess the interest of using a virtual reality headset in the support of pain relief and the management of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient (age ≥ 18 years)
Hospitalized in a day-hospitalization department at the General Hospital of Le Mans
For whom a diagnosis of radiculalgia with a duration of less than 6 months is made, for which the imaging is compatible with the symptoms according to the clinician's interpretation
For whom the indication of at least 2 epidural injections by the way of the sacrococcygeal hiatus is retained
Disqualifiers
Patient with comorbidity of epilepsy
Patient with a contraindication to performing epidural injections through the sacrococcygeal hiatus
Patient suffering from blindness and / or deafness
Person with a known significant intolerance towards the use of screens and / or virtual reality devices
Trial design
Crossover
Treatments tested in this trial
Virtual reality headset for first injection
DevicePerforming the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
Virtual reality headset for second injection
DevicePerforming the second ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus
Peri-procedural anxiety was measured with State and Trait Anxiety Index (STAI)
Secondary outcomes
Assessment of the patient's anxiety
Assessment of the patient's peri-procedural anxiety using the French version of the APAIS
Measure of the duration of the intervention
Assessment of patient's pain
Evaluation of maximum periprocedural pain on a numerical scale from 0 to 10
Evaluation of the patient satisfaction
Evaluation of the patient satisfaction with the virtual reality device on a 4-level scale, with values of 1, 2, 3 and 4 (quantitative variable).
Sponsors and contacts
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