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

NCT ID: NCT05289999

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2024-06-01

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.

Conditions

Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Using the virtual reality headset for the first injection

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

Group Type: EXPERIMENTAL

Virtual reality headset for first injection

Intervention Type: DEVICE

Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset

Using the virtual reality headset for the second injection

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

Group Type: EXPERIMENTAL

Virtual reality headset for second injection

Intervention Type: DEVICE

Performing the second ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset

Interventions

Virtual reality headset for first injection

Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset

Intervention Type: DEVICE

Virtual reality headset for second injection

Performing the second ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier le Mans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Du Mans

Le Mans, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christelle JADEAU

Role: CONTACT

cjadeau@ch-lemans.fr

+33244710781

Facility Contacts

Christelle JADEAU

Role: primary

cjadeau@ch-lemans.fr

+33244710781

Other Identifiers

CHM-2021/S07/08

Identifier Type: -

Identifier Source: org_study_id