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

Radiotherapy Side Effect Clinical Trial

— MUSIC-RT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05289505
• Other study ID #: 2019-6-63-004
• Secondary ID: 2021-A00597-37
• Status: Completed
• Start date: January 18, 2022
• Est. completion date: March 26, 2023

Study information

• Verified date: September 2022
• Source: Center Eugene Marquis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 26, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Radiotherapy Side Effect

Intervention

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.

Locations

Country	Name	City	State
France	Centre de Lutte contre le Cancer Eugène Marquis	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.