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)

Centre Hospitalier Universitaire de Nīmes

Status

Not yet enrolling

Conditions

Anxiety

Low Back Pain

Treatments

Other: Music Care® device

Other: EMONO

Study type

Interventional

Funder types

Other

Identifiers

NCT06928740

NIMAO/2024-2/FT01

Details and patient eligibility

About

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.

Enrollment

128 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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