Evaluation of Music on the Level of Anxiety Felt During External Radiotherapy Sessions (MUSIC-RT)

Center Eugene Marquis

Status: Completed

Conditions: Radiotherapy Side Effect

Treatments: Device: MUSIC-CARE

Study type: Observational

Funder types: Other

Identifiers

NCT05289505

2021-A00597-37 (Registry Identifier)

2019-6-63-004

Details and patient eligibility

About

This is a prospective study with a historical comparator. Each of the prospective study endpoints will be compared to data collected retrospectively in patients treated with radiation therapy prior to the implementation of the MUSIC-CARE device.

Full description

The retrospective phase (historical comparator) includes all patients with an initial HADS score > 7 who were treated with radiotherapy during 6 months preceding the start of the prospective study. The prospective phase involves all patients with an initial HADS score > 7 who will be treated with radiotherapy and who will benefit from music sessions (MUSIC-CARE). The study will be conducted over a fixed period of 12 months (6 months recruitment and 6 months follow-up) from the first patient receiving music sessions. Anxiety will be assessed by HADS self-questionnaires, before radiotherapy, at the end of the first week and at the end of radiotherapy. These evaluation parameters will therefore be compared to the 6-month period prior to the start of the study (retrospective phase).

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age
• Patients undergoing radiotherapy for curative treatment
• Patients with at least 15 sessions of radiotherapy
• Patients with an anxiety score > 7 on the total A of the HADS scale at the time of medical consultation

Exclusion criteria

• Minor patients
• Pregnant or breastfeeding patients
• Patients with major hearing loss
• Patients with psychotic disorders
• Patients who do not understand or read the French language
• Patients under guardianship or deprived of liberty
• Patients requiring radiotherapy with respiratory servo-control (the MUSIC-CARE cannot be used due to technical constraints)

Trial design

83 participants in 1 patient group

Prospective phase

Description:

This prospective phase involves all patients with an initial HADS score \> 7 and initiating treatment in the radiotherapy department. The treatment sessions will be performed with music, using the MUSIC-CARE device. In the event of technical problems, unavailability of equipment, or the patient's wishes, some radiotherapy sessions may be conducted without music. Nevertheless, a minimum of one weekly session with music is required for the analysis of the study.

Treatment:

Device: MUSIC-CARE