Virtual reality for easing pain and pre-procedure anxiety during sacrococcygeal sacral epidural injections
Official title: Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology
Run by Centre Hospitalier le Mans · NCT05289999 · Data updated 2026-11-12
A virtual reality headset is tested to see if it helps adults with radiculopathy feel less pain and anxiety during their first two sacrococcygeal epidural injections.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Centre Hospitalier le Mans Academic / other |
| Locations | 1 site (Le Mans) |
| Status | Recruiting |
| Started | June 10, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT05289999 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults diagnosed with radicular pain lasting less than 6 months, planned for at least two sacrococcygeal epidural injections, and who are VR-naive and able to complete self-administered surveys.
✕Probably not a fit
Patients who do not experience anxiety or pain reduction with distraction techniques or who cannot tolerate VR headsets may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study investigates whether using a virtual reality headset during sacrococcygeal epidural injections for radiculopathy reduces perceived pain and procedure-related anxiety. Participants are adults with recent radicular symptoms undergoing planned injections in a day-hospital setting. The approach leverages distraction and psycho-corporal support to potentially improve tolerability of the procedure. The study compares the patient experience during injections with VR support to a standard approach, focusing on short-term pain and anxiety outcomes. Safety and feasibility of VR use in this procedural context are also assessed.
Why it matters
Potential benefit: If successful, VR support could lessen pain and anxiety during epidural injections and improve the overall patient experience.
How similar studies have gone: Previous research has shown VR can reduce pain and anxiety in various medical procedures, supporting exploration in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Centre Hospitalier Du Mans
Le Mans, France Recruiting
Study contacts
- Study coordinator: Christelle JADEAU
- Email: cjadeau@ch-lemans.fr
- Phone: +33244710781
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.