Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology

Radiculopathy Clinical Trial

— REAVIR  

Official title:

Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05289999
• Other study ID #: CHM-2021/S07/08
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2022
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: +33244710781
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Patient receiving benzodiazepines and / or other sedative treatment

• 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

Related Conditions & MeSH terms

• Radiculopathy

Intervention

Device:
• Virtual reality headset for first injection
Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
• Virtual reality headset for second injection
Performing the second ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset

Locations

Country	Name	City	State
France	Centre Hospitalier Du Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 7