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

NCT05289999 | Recruiting

• 1 other identifier: CHM-2021/S07/08
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

epidural injection; virtual reality; pain management; performance anxiety

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Assessment of the patient's anxiety

  Immediately after intervention

• Measure of the duration of the intervention

  Immediately after intervention

• Assessment of patient's pain

  During intervention

• Evaluation of the patient satisfaction

  Immediately after intervention

• Evaluation of the practitioner satisfaction

  Immediately after intervention

Study Arms (2)

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

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

Device: Virtual reality headset for second injection

Interventions

Virtual reality headset for first injection DEVICE

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

Using the virtual reality headset for the first injection

Virtual reality headset for second injection DEVICE

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

Using the virtual reality headset for the second injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

Radiculopathy; Agnosia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christelle JADEAU

CONTACT

+33244710781; cjadeau@ch-lemans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 22, 2022
• Study Start: June 10, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

FR (1)