Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology (REAVIR)
Primary Purpose
Radiculopathy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality headset for first injection
Virtual reality headset for second injection
Sponsored by
About this trial
This is an interventional supportive care trial for Radiculopathy focused on measuring epidural injection, virtual reality, pain management, performance anxiety
Eligibility 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
- 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
Sites / Locations
- Centre Hospitalier Du MansRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Using the virtual reality headset for the first injection
Using the virtual reality headset for the second injection
Arm Description
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
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05289999
First Posted
March 3, 2022
Last Updated
July 27, 2022
Sponsor
Centre Hospitalier le Mans
1. Study Identification
Unique Protocol Identification Number
NCT05289999
Brief Title
Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology
Acronym
REAVIR
Official Title
Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier le Mans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy
Keywords
epidural injection, virtual reality, pain management, performance anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Using the virtual reality headset for the first injection
Arm Type
Experimental
Arm Description
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
Arm Title
Using the virtual reality headset for the second injection
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Virtual reality headset for first injection
Intervention Description
Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
Intervention Type
Device
Intervention Name(s)
Virtual reality headset for second injection
Intervention Description
Performing the second ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
Primary Outcome Measure Information:
Title
Evaluation of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus
Description
Peri-procedural anxiety was measured with State and Trait Anxiety Index (STAI)
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle JADEAU
Phone
+33244710781
Email
cjadeau@ch-lemans.fr
Facility Information:
Facility Name
Centre Hospitalier Du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle JADEAU
Phone
+33244710781
Email
cjadeau@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Amélie DENIS, MD
12. IPD Sharing Statement
Learn more about this trial
Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology
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