Anxiety, Low Back Pain
Conditions
Keywords
Music therapy, Computerized tomography scan, ENOMO, Radiographer
Brief summary
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.
Interventions
OTHEREMONO
Equimolar mixture of oxygen and nitrous oxide given as usual care
OTHERMusic Care® device
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.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * Patients with low back pain for whom scan-guided infiltration is indicated, whether at the foraminal level, posterior joints, pudendal, epidural, sacroiliac, or via the sacrococcygeal hiatus. * Patient with an anxiety score ≥ 35/100 based on the STAI-ETAT questionnaire
Exclusion criteria
* The subject is participating in another drug or category I interventional study, or is in a period of exclusion determined by a previous study * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * Indication for epidural injection * Patient who is deaf or hard of hearing * Contraindications to EMONO * Facial or head trauma making it impossible to wear a nasofacial mask or headphones
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety between groups | Baseline | 0-100 visual analog scale (VSA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction between groups | Day 0: Before discharge from imagery department | 0-100 visual analog scale (VSA) |
| Patient comfort between groups | Day 0: After injection of corticosteroids | 0-100 visual analog scale (VSA) |
| Patient-reported pain between groups | Day 0: Before injection of corticosteroids | 0-100 visual analog scale (VSA) |
| Anxiety between groups according to type of injection (foraminal, pudendal or posterior articular) | Day 0: Before injection of corticosteroids | 0-100 visual analog scale (VSA) |
| Anxiety between groups according to type of injection (foraminal, pudendal or posterior, articular, epidural, sacroiliac joints, and sacrococcygeal hiatus) | Day 0: After injection of corticosteroids | 0-100 visual analog scale (VSA) |
| Satisfaction of radiographer between groups | Day 0 | 0-100 visual analog scale (VSA) |
| Rate of adverse events between groups | Day 0: During procedure | According to Common Terminology Criteria for Adverse Events version 5.0 (grade 1-5) |
| Rate of complications between groups | Day 0: During procedure | According to Clavien-Dindo (grade I-V) |
Countries
France
Contacts
CONTACTFlorelle TERRA
PRINCIPAL_INVESTIGATORFlorelle TERRA
Centre Hospitalier Universitaire de Nīmes
Outcome results
None listed