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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2025-A00458-41 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infiltration | Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | day one |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day one |
| To Modified Client satisfaction score (CSQ-8) score according to the location of the infiltration |
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Inclusion Criteria:
Exclusion Criteria:
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Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice COURTIES, Medical doctor | Contact | +33 (0)1 49 28 25 20 | alice.courties@ahp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Alice COURTIES, Medical doctor | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology department Hôpital Saint Antoine | Recruiting | Paris | 75012 | France |
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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. |
| 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. | 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. | day one |
| To Compare pain during infiltration to anticipated pain from infiltration using a numerical scale |
| day one |
| Evaluate the added duration of the gesture by using the virtual reality headset | Duration of the gesture in minutes | 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 | day one |
| Describe the tolerance of the Virtual Reality headset | Proportion of immediate side effects to the virtual reality headset | day one |