CompletedNot Applicable

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

France30 participantsStarted 2025-05-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess patient satisfaction with the use of 3D virtual reality with hypnotic induction during infiltration using Modified Client satisfaction score (CSQ-8)

Timeframe: day one

Trial details

NCT IDNCT07103096

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-28

View on ClinicalTrials.gov More Infiltration trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.