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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07103096
Acronym
Icare
Enrollment
30
Registered
2025-08-05
Start date
2025-05-28
Completion date
2026-05-28
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infiltration

Keywords

infiltration, 3D virtual reality headset

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To assess patient satisfaction with the use of 3D virtual reality with hypnotic induction during infiltration using Modified Client satisfaction score (CSQ-8)day oneModified Client satisfaction score (CSQ-8) Minimum value: 0= not satisfied. Maximum value= 4 totally satisfied. Higher score mean better outcome.

Secondary

MeasureTime frameDescription
To assess investigator satisfactionDay oneNumber of times the doctor is satisfied according to the 5-point Likert scale of satisfaction. Minimum value: 0= not satisfied. Maximum value= 5 totally satisfied. Higher score mean better outcome.
To Modified Client satisfaction score (CSQ-8) score according to the location of the infiltrationDay oneModified Client satisfaction score (CSQ-8) according to the location of the infiltration. Minimum value: 0= not satisfied. Maximum value= 4 totally satisfied. Higher score mean better outcome.
Assess the patient's anxiety during infiltration using a numerical scaleday oneNumerical scale patient anxiety during infiltration: mean (standard deviation). Minimum value: 0= Not at all anxious. Maximum value= 10 very anxious. Higher score mean worse outcome.
To Assess the patient's pain during the infiltration using a numerical scale.day onePatient pain numerical scale during infiltration: mean (standard deviation) Minimum value: 0= no pain. Maximum value= 10 the worst pain imaginable. Higher score mean worse outcome.
To Compare pain during infiltration to anticipated pain from infiltration using a numerical scaleday one* Numerical scale of pain during infiltration Minimum value: 0= no pain. Maximum value= 10 the worst pain imaginable. Higher score mean worse outcome. * Numerical scale of anticipated pain of infiltration. Minimum value: 0= no anticipated pain. Maximum value= 10 the worst anticipated pain imaginable. Higher score mean worse outcome.
Evaluate the added duration of the gesture by using the virtual reality headsetday oneDuration of the gesture in minutes
Compare the duration of the gesture with hypnotic 3D virtual reality versus the assumed duration without the use of the headsetday oneAverage added time by the Virtual Reality headset according to the doctor
Describe the tolerance of the Virtual Reality headsetday oneProportion of immediate side effects to the virtual reality headset

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAlice COURTIES, Medical doctor

APHP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026