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

NCT ID: NCT07103096

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2026-05-31

Brief Summary

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.

Detailed 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.

Conditions

Infiltration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infiltration

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

No interventions assigned to this group

Eligibility Criteria

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

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

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice COURTIES, Medical doctor

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Rheumatology department Hôpital Saint Antoine

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Alice COURTIES, Medical doctor

Role: CONTACT

alice.courties@ahp.fr

+33 (0)1 49 28 25 20

Facility Contacts

Alice COURTIES, Medical doctor

Role: primary

alice.courties@ahp.fr

+33 (0)1 49 28 25 20

Other Identifiers

IDRCB 2025-A00458-41

Identifier Type: OTHER

Identifier Source: secondary_id

APHP250404

Identifier Type: -

Identifier Source: org_study_id