An interventional study of Virtual reality headset for first injection and Virtual reality headset for second injection in Radiculopathy, sponsored by Centre Hospitalier le Mans. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Centre Hospitalier le Mans · Not applicable, Interventional, and Supportive care
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.
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 373 interventional studies indexed under Radiculopathy.
Browse Radiculopathy studies →Centre Hospitalier le Mans is the lead sponsor of 44 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset, then the second injection following the usual conditions of care without the device
Device: Virtual reality headset for first injection
Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus following the usual conditions of care, then the second injection using the virtual reality headset
Device: Virtual reality headset for second injection
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
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)
Time frame: Day 7
Assessment of the patient's anxiety
Assessment of the patient's peri-procedural anxiety using the French version of the APAIS
Time frame: Immediately after intervention
Measure of the duration of the intervention
Time frame: Immediately after intervention
Assessment of patient's pain
Evaluation of maximum periprocedural pain on a numerical scale from 0 to 10
Time frame: During intervention
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).
Time frame: Immediately after intervention
Evaluation of the practitioner satisfaction
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: Immediately after intervention
Evaluation of lumbar and radicular pain
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: Before intervention
Tolerance and Comfort Questionnaire
Time frame: Immediately after intervention
Record of undesirable events
Time frame: Before intervention
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Centre Hospitalier le Mans