Evaluation of Music on the Level of Anxiety Felt During External Radiotherapy Sessions

NCT05289505 | Completed

• 2 other identifiers: 2019-6-63-0042021-A00597-37
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiotherapy Side Effect

Keywords

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

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.

Prospective phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (1)

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, 35042, France

Location

MeSH Terms

Conditions

Radiation Injuries; Anxiety Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; Mental Disorders

Study Officials

• Coralie Hulot

  Centre de Lutte contre le Cancer Eugène Marquis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 21, 2022
• Study Start: January 18, 2022
• Primary Completion: August 31, 2022
• Study Completion: March 26, 2023
• Last Updated: April 4, 2024

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)