An observational study in Infiltration, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee
Exclusion Criteria:
Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee
To assess patient satisfaction with the use of 3D virtual reality with hypnotic induction during infiltration using Modified Client satisfaction score (CSQ-8)
Modified Client satisfaction score (CSQ-8) Minimum value: 0= not satisfied. Maximum value= 4 totally satisfied. Higher score mean better outcome.
Time frame: day one
To assess investigator satisfaction
Number 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.
Time frame: Day one
To Modified Client satisfaction score (CSQ-8) score according to the location of the infiltration
Modified 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.
Time frame: Day one
Assess the patient's anxiety during infiltration using a numerical scale
Numerical 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.
Time frame: day one
To Assess the patient's pain during the infiltration using a numerical scale.
Patient 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.
Time frame: day one
To Compare pain during infiltration to anticipated pain from infiltration using a numerical scale
* 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.
Time frame: day one
Evaluate the added duration of the gesture by using the virtual reality headset
Duration of the gesture in minutes
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
Average added time by the Virtual Reality headset according to the doctor
Time frame: day one
Describe the tolerance of the Virtual Reality headset
Proportion of immediate side effects to the virtual reality headset
Time frame: day one
Plan to share: No
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris