Rheumatology department Hôpital Saint Antoine
Paris, 75012, France
Location status: Recruiting
NCT Number: NCT07103096
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, 75012, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: day one
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
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
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
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
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
Time frame: day one
Duration of the gesture in minutes
Time frame: day one
Average added time by the Virtual Reality headset according to the doctor
Time frame: day one
Proportion of immediate side effects to the virtual reality headset
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Infiltration in Rheumatology With 3D Virtual Reality Headset Pilot Study for the Evaluation of Satisfaction and Feasibility According to Location (Icare)
Acronym: Icare
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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