Infiltration in Rheumatology With 3D Virtual Reality Headset Pilot Study for the Evaluation of Satisfaction (ICARE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infiltration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Infiltration in Rheumatology With 3D Virtual Reality Headset Pilot Study for the Evaluation of Satisfaction and Feasibility According to Location (Icare)
Overview
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.
Primary outcome measures
- To assess patient satisfaction with the use of 3D virtual reality with hypnotic induction during infiltration using Modified Client satisfaction score (CSQ-8) [Time frame: day one]
Secondary outcome measures (8)
- To assess investigator satisfaction [Time frame: Day one]
- To Modified Client satisfaction score (CSQ-8) score according to the location of the infiltration [Time frame: Day one]
- Assess the patient's anxiety during infiltration using a numerical scale [Time frame: day one]
- To Assess the patient's pain during the infiltration using a numerical scale. [Time frame: day one]
- To Compare pain during infiltration to anticipated pain from infiltration using a numerical scale [Time frame: day one]
- Evaluate the added duration of the gesture by using the virtual reality headset [Time frame: day one]
- Compare the duration of the gesture with hypnotic 3D virtual reality versus the assumed duration without the use of the headset [Time frame: day one]
- Describe the tolerance of the Virtual Reality headset [Time frame: day one]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Rheumatology department Hôpital Saint Antoine — Paris
Identifiers
NCT: NCT07103096 · APHP250404 · IDRCB 2025-A00458-41