NCT06928740

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
37mo left

Started Oct 2025

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Oct 2025Jun 2029

First Submitted

Initial submission to the registry

April 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

October 21, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

April 8, 2025

Last Update Submit

February 18, 2026

Conditions

Low Back PainAnxiety

Keywords

Music therapyComputerized tomography scanENOMORadiographer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • Patient satisfaction between groups

    Day 0: Before discharge from imagery department

  • Patient comfort between groups

    Day 0: After injection of corticosteroids

  • Patient-reported pain between groups

    Day 0: Before injection of corticosteroids

  • Patient-reported pain between groups

    Day 0: After injection of corticosteroids

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

    Day 0: Before injection of corticosteroids

  • +6 more secondary outcomes

Study Arms (2)

Music Care

EXPERIMENTAL
Other: Music Care® device

Control

ACTIVE COMPARATOR
Other: EMONO

Interventions

EMONOOTHER

Equimolar mixture of oxygen and nitrous oxide given as usual care

Control
Music Care® deviceOTHER

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.

Music Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nimes

Nîmes, France

RECRUITING

MeSH Terms

Conditions

Low Back PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Florelle TERRA

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florelle TERRA

CONTACT

06.37.59.77.34florelle.terra@chu-nimes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 15, 2025

Study Start

October 21, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2029

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

FR(1)