Clinical trial NCT06928740: Efficacy on Anxiety of the Digital Music Application Versus Equimolar Mixture of Oxygen and Nitrous Oxide in Patients Receiving CT-guided Lumbar Infiltration
Official title: Evaluation de l'efficacité Sur l'anxiété de l'Application numérique Musicale, Music Care® Versus MEOPA, Kalinox® Chez Des Patients bénéficiant d'Une Infiltration Lombaire scanoguidée. Etude Monocentrique contrôlée randomisée de Non infériorité en Ouvert.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Anxiety
Keywords: Music therapy
Computerized tomography scan
ENOMO
Radiographer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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
* Patient with low back pain and an indication for CT-guided foraminal, posterior joint, or pudendal injection
* 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
* Patient who has already received a CT-guided posterior articular, foraminal, epidural, or pudendal injection
* Indication for epidural or cervical 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
* Patient who has taken an anxiolytic medication within 24 hours prior to the injection

Primary outcomes:
measure: Anxiety between groups
timeFrame: Baseline
measure: Anxiety between groups
timeFrame: Day 0: upon locating helix and a skin location
measure: Anxiety between groups
timeFrame: Day 0: before injection of corticosteroids
Secondary outcomes:
measure: Patient satisfaction between groups
timeFrame: Day 0: Before discharge from imagery department
measure: Patient comfort between groups
timeFrame: Day 0: After injection of corticosteroids
measure: Patient-reported pain between groups
timeFrame: Day 0: Before injection of corticosteroids
measure: Patient-reported pain between groups
timeFrame: Day 0: After injection of corticosteroids
measure: Anxiety between groups according to type of injection (foraminal, pudendal or posterior articular)
timeFrame: Day 0: Before injection of corticosteroids
measure: Anxiety between groups according to type of injection (foraminal, pudendal or posterior articular)
timeFrame: Day 0: After injection of corticosteroids
measure: Satisfaction of radiographer between groups
timeFrame: Day 0
measure: Rate of adverse events between groups
timeFrame: Day 0: During procedure
measure: Rate of adverse events between groups
timeFrame: Day 0: immediately after procedure
measure: Rate of complications between groups
timeFrame: Day 0: During procedure
measure: Rate of complications between groups
timeFrame: Day 0: immediately after procedure
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Florelle TERRA
role: PRINCIPAL_INVESTIGATOR
References: