RadiculopathyREAVIRNCT05289999
Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology
A study testing Virtual reality headset for first injection and Virtual reality headset for second injection in people with Radiculopathy, run by Centre Hospitalier le Mans at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy
- What is being tested?
- Virtual reality headset for first injection and Virtual reality headset for second injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Du Mans
Le Mans, 72000
Christelle JADEAU, +33244710781, cjadeau@ch-lemans.fr
Amélie DENIS, MD
About this study
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.
- Conditions
- Radiculopathy
- Being tested
- Virtual reality headset for first injection, Virtual reality headset for second injection
- Keywords
- epidural injection, virtual reality, pain management, performance anxiety
- Medical subject headings
- Radiculopathy, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headset for first injectionDevice
Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
Virtual reality headset for second injectionDevice
Performing the second ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
| Study group | Role | What they receive |
|---|---|---|
| Using the virtual reality headset for the first injection | Experimental | 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 Receives: Device: Virtual reality headset for first injection |
| Using the virtual reality headset for the second injection | Experimental | 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 Receives: Device: Virtual reality headset for second injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 7
Secondary outcomes (8)
Assessment of the patient's anxiety
Assessment of the patient's peri-procedural anxiety using the French version of the APAIS
Measured: Immediately after intervention
Measure of the duration of the intervention
Measured: Immediately after intervention
Assessment of patient's pain
Evaluation of maximum periprocedural pain on a numerical scale from 0 to 10
Measured: 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).
Measured: 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)
Measured: 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
Measured: Before intervention
Tolerance and Comfort Questionnaire
Measured: Immediately after intervention
Record of undesirable events
Measured: Before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start10 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289999
- Sponsor's protocol ID
- CHM-2021/S07/08
- Acronym
- REAVIR
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology
- ClinicalTrials.gov ID
- NCT05289999
- Acronym / sponsor ID
- REAVIR / CHM-2021/S07/08
- Conditions
- Radiculopathy
- Keywords
- epidural injection, virtual reality, pain management, performance anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using the virtual reality headset for the first injection | Experimental | Device: Virtual reality headset for first injectionPerforming 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 |
| Using the virtual reality headset for the second injection | Experimental | Device: Virtual reality headset for second injectionPerforming 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality headset for first injectionPerforming the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset | Device | Using the virtual reality headset for the first injection |
| Virtual reality headset for second injectionPerforming the second ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset | Device | Using the virtual reality headset for the second injection |
Primary outcome
Evaluation of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus
Time frame: Day 7
Peri-procedural anxiety was measured with State and Trait Anxiety Index (STAI)
8 secondary outcomes
Assessment of the patient's anxiety
Time frame: Immediately after intervention
Measure of the duration of the intervention
Time frame: Immediately after intervention
Assessment of patient's pain
Time frame: During intervention
Evaluation of the patient satisfaction
Time frame: Immediately after intervention
Evaluation of the practitioner satisfaction
Time frame: Immediately after intervention
Evaluation of lumbar and radicular pain
Time frame: Before intervention
Tolerance and Comfort Questionnaire
Time frame: Immediately after intervention
Record of undesirable events
Time frame: Before intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset for first injection and Virtual reality headset for second injection in people with Radiculopathy, run by Centre Hospitalier le Mans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle JADEAU (+33244710781, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.