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

ConditionInfiltration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: Infiltration

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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