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.

Overview

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

• Other Music 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.
• Other EMONO
  Equimolar mixture of oxygen and nitrous oxide given as usual care

Primary outcome measures

• Anxiety between groups [Time frame: Baseline]
• Anxiety between groups [Time frame: Day 0: upon locating helix and a skin location]
• Anxiety between groups [Time frame: Day 0: before injection of corticosteroids]

Secondary outcome measures (11)

• Patient satisfaction between groups [Time frame: Day 0: Before discharge from imagery department]
• Patient comfort between groups [Time frame: Day 0: After injection of corticosteroids]
• Patient-reported pain between groups [Time frame: Day 0: Before injection of corticosteroids]
• Patient-reported pain between groups [Time frame: Day 0: After injection of corticosteroids]
• Anxiety between groups according to type of injection (foraminal, pudendal or posterior articular) [Time frame: 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) [Time frame: Day 0: After injection of corticosteroids]
• Satisfaction of radiographer between groups [Time frame: Day 0]
• Rate of adverse events between groups [Time frame: Day 0: During procedure]
• Rate of adverse events between groups [Time frame: Day 0: immediately after procedure]
• Rate of complications between groups [Time frame: Day 0: During procedure]
• Rate of complications between groups [Time frame: Day 0: immediately after procedure]

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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• CHU de Nimes — Nîmes

Identifiers

NCT: NCT06928740 · NIMAO/2024-2/FT01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗