Centre Hospitalier Du Mans
Le Mans, 72000, France
Location status: Recruiting
NCT Number: NCT05289999
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Le Mans, 72000, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
Performing the second ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
Time frame: Day 7
Peri-procedural anxiety was measured with State and Trait Anxiety Index (STAI)
Time frame: Immediately after intervention
Assessment of the patient's peri-procedural anxiety using the French version of the APAIS
Time frame: Immediately after intervention
Time frame: During intervention
Evaluation of maximum periprocedural pain on a numerical scale from 0 to 10
Time frame: Immediately after intervention
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).
Time frame: Immediately after intervention
Evaluation of the practitioner satisfaction with the virtual reality device on a 4-level scale, with values of 1, 2, 3 and 4 (quantitative variable)
Time frame: Before intervention
Assessment of lumbar pain on a numerical scale from 0 to 10 and of radicular pain on a numerical scale from numerical scale from 0 to 10
Time frame: Immediately after intervention
Time frame: Before intervention
Contact information is provided by the study sponsor or research team.
Centre Hospitalier le Mans
Other
Acronym: REAVIR
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