Actively Recruiting

Age: 18Years +
All Genders
ID07103096

Infiltration in Rheumatology With 3D Virtual Reality Headset Pilot Study for the Evaluation of Satisfaction and Feasibility According to Location (Icare)

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-05

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of a 3D virtual reality headset combined with hypnotic audio induction to improve patient satisfaction and feasibility during infiltrative procedures in rheumatology. These infiltrations, often performed on the spine, subacromial-deltoid bursa, or knee, can cause significant anticipatory anxiety and pain. The study aims to understand how this technology affects patient and physician satisfaction as well as its impact on procedure duration, especially depending on the infiltration location. Participants in this observational study will use the 3D virtual reality headset with hypnotic induction during their infiltration procedure. The study focuses on infiltrations of specific locations including the spine, subacromial-deltoid bursa, and knee. The feasibility of this approach will be assessed by measuring any added time to the procedure. The study does not involve any drug or placebo but observes the effects and acceptability of the virtual reality intervention during routine care. During the study, patients will be assessed for satisfaction using the Modified Client Satisfaction score (CSQ-8), anxiety and pain levels during infiltration with numerical scales, and comparison of actual pain versus anticipated pain. Investigators will also evaluate their satisfaction with the procedure. Researchers will monitor the tolerance of the virtual reality headset and compare procedure durations with and without the headset. All assessments occur on the day of the infiltration, with participation lasting for this single visit.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus), subacromial-deltoid bursa, or knee
  • Receiving care within the Rheumatology department of Saint-Antoine hospital (consultation or hospitalized)
Not Eligible

You will not qualify if you...

  • History of severe psychiatric disorders or epilepsy
  • Cognitive disorders
  • Language barrier or hearing aid-assisted deafness and/or major vision loss (advanced cataract, visual impairment)
  • Infiltration in the specified locations within the past 6 months
  • Recently diagnosed or unstable characterized depressive disorder (less than 6 months)
  • Previous use of a virtual reality headset during treatment
  • Under guardianship or curatorship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Day one

Participants undergo infiltration procedures with or without the use of a 3D virtual reality headset and hypnotic induction to evaluate satisfaction, anxiety, pain, and procedure duration.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Rheumatology department Hôpital Saint Antoine

Paris, France, 75012

Actively Recruiting

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Research Team

A

Alice COURTIES, Medical doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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