Evaluation of Music 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radiotherapy Side Effect Anxiety Disorders Mental Disorders Radiation Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, 35042, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

MUSIC-CARE

Device

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.

Primary outcomes

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.

Time frame: 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.

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.

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Official study title

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

Acronym: MUSIC-RT

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Mar 21, 2022
Registry last updated: Apr 4, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed