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Infiltration in Rheumatology With 3D Virtual Reality Headset Pilot Study for the Evaluation of Satisfaction (ICARE) (Icare)

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Infiltration

Study type

Observational

Funder types

Other

Identifiers

NCT07103096
APHP250404
IDRCB 2025-A00458-41 (Other Identifier)

Details and patient eligibility

About

This study is to evaluate the satisfaction and feasibility according to the location of the use of a 3D virtual reality headset during an infiltration in rheumatology.

Full description

The performance of infiltrative procedures in rheumatology is common, even daily, practice. It may be associated with anticipatory anxiety and pain (for example, during a shoulder infiltration, there is a significant difference between anticipated pain and pain felt with a visual analogue scale of 6.03 versus 3.17, P < 0.001) as well as pain and anxiety during the procedure. Certain techniques are used to limit this anxiety and pain in common practice such as explaining the procedure before and during its performance, the atmosphere (particularly musical atmosphere) and decoration of the room where the procedure takes place (relaxing images visible to the patient, brightness, people present) and the attitude of the practitioner. More recently, hypnosis and/or 3D virtual reality techniques using a virtual reality headset have been implemented in medicine and particularly in rheumatology to help manage chronic or acute pain. Thus, we currently use a virtual reality headset associated with hypnotic induction (using an audio headset) for the performance of many infiltrative procedures. However, there is no data concerning the acceptability and satisfaction of the patient and the physician of the addition of this technique (VR headset with hypnotic induction) nor its feasibility in current practice (extension of the procedure time for example), during an infiltration nor to know if these data can vary according to the infiltrated location.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 years or older
  • Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee, regardless of the product infiltrated
  • Within the Rheumatology department of Saint-Antoine hospital (consultation or hospitalized)

Exclusion criteria

  • History of severe psychiatric disorders - History of epilepsy
  • Cognitive disorders
  • Language barrier - Hearing aid-assisted deafness and/or ophthalmological problems leading to a major loss of vision (advanced cataract, visual impairment)
  • Infiltration of the spine (high epidural or sacrococcygeal hiatus), subacromial-deltoid bursa or knee < 6 months
  • Characterized depressive disorder diagnosed recently (for less than 6 months) or not stabilized
  • Previous use of a virtual reality headset during treatment
  • Being under guardianship or curatorship

Trial design

30 participants in 1 patient group

Infiltration
Description:
Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee

Trial contacts and locations

1

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Central trial contact

Alice COURTIES, Medical doctor

Data sourced from clinicaltrials.gov

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