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Since the Covid-19 crisis, patients appear more stressed, with increasing fear of exams and the hospital environment, in particular for CT scan teams, which require injections. Currently, an equimolar mixture of oxygen and nitrous oxide (EMONO) is used to calm patients. However, the patient's prone position complicates its use, with patients sometimes in painful position and the discomfort of gas inhalation (nausea, dizziness, etc.), as well as reduced lung capacity. Greater patient anxiety increases the risk of complications, or even failure, (unexpected movement, stiffness, refusal to complete the procedure, etc.). In this study, music therapy using Music Care® tablets, was tested to replace EMONO. The study authors hypothesize that the use of the Music Care® device will have a comparable efficacy to that of EMONO (non-inferiority) in reducing patient anxiety during CT-guided lumbar infiltration. Furthermore, the study authors hypothesize that this simple, non-invasive method, with no contraindications for the patient, will be better tolerated and appreciated by both the patient and the paramedical team in charge of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Care | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Care® device | Other | Installation of the Music Care® device, selection of the sequence based on the patient's musical taste, listening to at least 20-minute sequence in the preparation room. Once placed on the scanner table, the patient listens to the same sequence as in the preparation room. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety between groups | 0-100 visual analog scale (VSA) | Baseline |
| Anxiety between groups | 0-100 visual analog scale (VSA) | Day 0: upon locating helix and a skin location |
| Anxiety between groups | 0-100 visual analog scale (VSA) | Day 0: before injection of corticosteroids |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction between groups | 0-100 visual analog scale (VSA) | Day 0: Before discharge from imagery department |
| Patient comfort between groups | 0-100 visual analog scale (VSA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florelle TERRA | Contact | 06.37.59.77.34 | florelle.terra@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Florelle TERRA | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nimes | Recruiting | Nîmes | France |
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|
| EMONO | Other | Equimolar mixture of oxygen and nitrous oxide given as usual care |
|
| Day 0: After injection of corticosteroids |
| Patient-reported pain between groups | 0-100 visual analog scale (VSA) | Day 0: Before injection of corticosteroids |
| Patient-reported pain between groups | 0-100 visual analog scale (VSA) | Day 0: After injection of corticosteroids |
| Anxiety between groups according to type of injection (foraminal, pudendal or posterior articular) | 0-100 visual analog scale (VSA) | Day 0: Before injection of corticosteroids |
| Anxiety between groups according to type of injection (foraminal, pudendal or posterior, articular, epidural, sacroiliac joints, and sacrococcygeal hiatus) | 0-100 visual analog scale (VSA) | Day 0: After injection of corticosteroids |
| Satisfaction of radiographer between groups | 0-100 visual analog scale (VSA) | Day 0 |
| Rate of adverse events between groups | According to Common Terminology Criteria for Adverse Events version 5.0 (grade 1-5) | Day 0: During procedure |
| Rate of adverse events between groups | According to Common Terminology Criteria for Adverse Events version 5.0 (grade 1-5) | Day 0: immediately after procedure |
| Rate of complications between groups | According to Clavien-Dindo (grade I-V) | Day 0: During procedure |
| Rate of complications between groups | According to Clavien-Dindo (grade I-V) | Day 0: immediately after procedure |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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