Radiculopathy
Conditions
Keywords
epidural injection, virtual reality, pain management, performance anxiety
Brief summary
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.
Interventions
DEVICEVirtual reality headset for first injection
Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
DEVICEVirtual reality headset for second injection
Performing the second ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
Sponsors
Centre Hospitalier le Mans
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Having never experienced an epidural injection through the sacrococcygeal hiatus * Patient able and willing to answer the auto-administered surveys * Person affiliated or beneficiary of a social security * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research) after oral and written information
Exclusion criteria
* 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 * Patient receiving benzodiazepines and / or other sedative treatment * Patient with a known depressive disease followed by a psychiatrist * Pregnant, breastfeeding or parturient woman * Person deprived of liberty by judicial or administrative decision * Person under forced psychiatric care * Person subject to legal protection * Person unable to express consent * Patient who had participated in an interventional study during the last 30 days * Severely impaired physical and / or mental health which, according to the investigator, may affect the compliance of the study participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus | Day 7 | Peri-procedural anxiety was measured with State and Trait Anxiety Index (STAI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the patient's anxiety | Immediately after intervention | Assessment of the patient's peri-procedural anxiety using the French version of the APAIS |
| Measure of the duration of the intervention | Immediately after intervention | — |
| Assessment of patient's pain | During intervention | Evaluation of maximum periprocedural pain on a numerical scale from 0 to 10 |
| Evaluation of the patient satisfaction | 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). |
| Evaluation of the practitioner satisfaction | 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) |
| Evaluation of lumbar and radicular pain | 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 |
| Tolerance and Comfort Questionnaire | Immediately after intervention | — |
| Record of undesirable events | Before intervention | — |
Countries
France
Contacts
CONTACTChristelle JADEAU
Outcome results
None listed