Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural … (NCT05289999) | Clinical Trial Compass
RecruitingNot Applicable
Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology
France70 participantsStarted 2022-06-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 protect…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus