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

Prospective and Monocentric Pilot Study of the Evaluation of the Music Delivered by the Music-Care Device on the Level of Anxiety Felt During External Radiotherapy Sessions

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.

Study Overview

• Status: Completed
• Conditions: Radiotherapy Side Effect
• Intervention / Treatment: Device: MUSIC-CARE

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35042
      • Centre de lutte contre le cancer Eugène Marquis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients, all cancers combined, with an initial HADS score > 7 and initiating treatment in the radiotherapy department are concerned by this study.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Prospective phase; 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.

Device: MUSIC-CARE; This device allows the listening of music using different sequences of instrumental music created specifically, and using principles based on hypno-analgesia, that is to say the association of hypnotic techniques and approaches to help or analgesic, medicated or not. It consists of a tablet application containing instrumental music pieces, specially created and recorded for Music-Care. Each piece is at least 20 minutes long. The music can be played through headphones or speakers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The main objective of the study is to evaluate the impact of the MUSIC-CARE device on the level of anxiety perceived by patients during radiotherapy.	Perceived anxiety will be measured by the anxiety score (total A), assessed with the Hospital Anxiety and Depression Scale (HADS). To screen for anxiety symptomatology, the following interpretation is: Total A score at 7 or less: no symptomatology, Total A score of 8 to 10: questionable symptomatology, and Total A score equal to 11 and above: definite symptomatology. Anxiety will be assessed at the medical consultation, after 5 sessions and at the end of the treatment. The patients' score after 5 sessions will be used as the primary endpoint to evaluate the impact of the to evaluate the impact of the device.	The analysis will take place after the last visit (usual 6-month visit) of the last included patient, i.e. 6 months after the end of treatment of the last patient, and within a maximum of one year after this visit.

Collaborators and Investigators

• Sponsor: Center Eugene Marquis
• Investigators: Principal Investigator: Coralie Hulot, Centre de lutte contre le cancer Eugène Marquis

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): March 26, 2023

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2019-6-63-004; 2021-A00597-37 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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