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NOT YET RECRUITING
NCT07806435
NA

Evaluation of the Effectiveness of Music Therapy on Anxiety Levels in Patients With Advanced Cancer Hospitalized in a Palliative Care Unit

Sponsor: Centre Hospitalier Universitaire, Amiens

View on ClinicalTrials.gov

Summary

A music therapy intervention can be either receptive or active. In both cases, somatic effects have been observed, with a direct impact on respiratory, cardiac and hemodynamic parameters, as well as psychological effects, creating a relationship of support, accompaniment and listening to the person. An intervention protocol using Kigonki has been developed and validated by the University Diploma in Music Therapy team at Paul-Valéry Montpellier 3 University (DUMM3). Studies on music therapy in palliative care have been published, but there is still a need for large controlled studies assessing the prolonged effect of a standardized intervention. This randomized clinical is designed for patients with terminal cancer pathology, hospitalized in palliative care units and with anxiety and depression scores both above 11 on the Hospital Anxiety and Depression scale (HAD). The primary endpoint is change in anxiety score. Patients included in the experimental arm will be offered the above-mentioned protocol with 3 weekly sessions of receptive music therapy with Kigonki for 2 weeks, after drawing up an intervention plan. Anxiety/depression levels will be measured before and 30 minutes after each session, as well as one week after the last session. Patients in the reference arm will have their anxiety/depression level monitored 3 times a week. In both arms, the study will be terminated at the end of the last protocol evaluation (i.e., at 3 weeks). If anxiety worsens (score rises by 2 points), a music therapy intervention similar to that performed for patients of the experimental arm may be proposed to patients of the reference arm. This project requires the participation of 84 patients, which seems feasible at the inter-regional level in 7 centers over 18 months.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2026-10

Completion Date

2028-04

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

OTHER

depression management

\- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.

OTHER

Kigonki

Six 30-minute sessions of receptive ISM with Kigonki according to study protocol

OTHER

questionnaire

Assessment of PANAS questionnaire, TSAI test, digital scale measurement, physiological constants (pulse, blood pressure, respiratory rate) 3 times a week for 2 weeks, then 7 days after the last of these 6 assessments.

Locations (1)

CHRU Amiens

Amiens, France