Efficacy on Anxiety of the Digital Music Application Versus Equimolar Mixture of Oxygen and Nitrous Oxide in Patients Receiving CT-guided Lumbar Infiltration (MKI-TDM)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Anxiety
• Intervention / Treatment: Other: Music Care® device; Other: EMONO

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florelle TERRA; Phone Number: 06.37.59.77.34; Email: florelle.terra@chu-nimes.fr

Study Locations

• France
  • Nîmes, France
    • Recruiting
    • CHU de Nîmes
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr
    • Principal Investigator: Florelle TERRA
    • Sub-Investigator: Julien FRANDON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Other: EMONO; Equimolar mixture of oxygen and nitrous oxide given as usual care
Experimental: Music Care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Florelle TERRA, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Music therapy; Radiographer; Computerized tomography scan; ENOMO
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anxiety Disorders; Low Back Pain
• Other Study ID Numbers: NIMAO/2024-2/FT01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No