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NCT Number: NCT06928740

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

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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Key information

Conditions

Low Back Pain Anxiety Anxiety Disorders Back Pain Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nimes

Nîmes, France

Location status: Recruiting

Location contact

Anissa Megzari

CONTACT

[email protected]

04.66.68.42.36

Florelle TERRA

PRINCIPAL_INVESTIGATOR

Julien FRANDON

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

EMONO

Other

Equimolar mixture of oxygen and nitrous oxide given as usual care

Primary outcomes

  1. Anxiety between groups

    Time frame: Baseline

    0-100 visual analog scale (VSA)

  2. Anxiety between groups

    Time frame: Day 0: upon locating helix and a skin location

    0-100 visual analog scale (VSA)

  3. Anxiety between groups

    Time frame: Day 0: before injection of corticosteroids

    0-100 visual analog scale (VSA)

Secondary outcomes

  1. Patient satisfaction between groups

    Time frame: Day 0: Before discharge from imagery department

    0-100 visual analog scale (VSA)

  2. Patient comfort between groups

    Time frame: Day 0: After injection of corticosteroids

    0-100 visual analog scale (VSA)

  3. Patient-reported pain between groups

    Time frame: Day 0: Before injection of corticosteroids

    0-100 visual analog scale (VSA)

  4. Patient-reported pain between groups

    Time frame: Day 0: After injection of corticosteroids

    0-100 visual analog scale (VSA)

  5. Anxiety between groups according to type of injection (foraminal, pudendal or posterior articular)

    Time frame: Day 0: Before injection of corticosteroids

    0-100 visual analog scale (VSA)

  6. 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

    0-100 visual analog scale (VSA)

  7. Satisfaction of radiographer between groups

    Time frame: Day 0

    0-100 visual analog scale (VSA)

  8. Rate of adverse events between groups

    Time frame: Day 0: During procedure

    According to Common Terminology Criteria for Adverse Events version 5.0 (grade 1-5)

  9. Rate of adverse events between groups

    Time frame: Day 0: immediately after procedure

    According to Common Terminology Criteria for Adverse Events version 5.0 (grade 1-5)

  10. Rate of complications between groups

    Time frame: Day 0: During procedure

    According to Clavien-Dindo (grade I-V)

  11. Rate of complications between groups

    Time frame: Day 0: immediately after procedure

    According to Clavien-Dindo (grade I-V)

Study contacts

Contact information is provided by the study sponsor or research team.

Florelle TERRA

CONTACT

[email protected]

06.37.59.77.34

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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.

Acronym: MKI-TDM

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Apr 15, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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