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NCT Number: NCT05289999

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Du Mans

Le Mans, 72000, France

Location status: Recruiting

Location contact

Amélie DENIS, MD

PRINCIPAL_INVESTIGATOR

Christelle JADEAU

CONTACT

[email protected]

+33244710781

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Virtual reality headset for first injection

Device

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

Virtual reality headset for second injection

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Assessment of the patient's anxiety

    Time frame: Immediately after intervention

    Assessment of the patient's peri-procedural anxiety using the French version of the APAIS

  2. Measure of the duration of the intervention

    Time frame: Immediately after intervention

  3. Assessment of patient's pain

    Time frame: During intervention

    Evaluation of maximum periprocedural pain on a numerical scale from 0 to 10

  4. Evaluation of the patient satisfaction

    Time frame: Immediately after intervention

    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).

  5. Evaluation of the practitioner satisfaction

    Time frame: Immediately after intervention

    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)

  6. Evaluation of lumbar and radicular pain

    Time frame: Before intervention

    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

  7. Tolerance and Comfort Questionnaire

    Time frame: Immediately after intervention

  8. Record of undesirable events

    Time frame: Before intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle JADEAU

CONTACT

[email protected]

+33244710781

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: REAVIR

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2022
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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