Evaluation of the Effectiveness of Music Therapy on Anxiety Levels in Patients With Advanced Cancer Hospitalized in a Palliative Care Unit (CessataEl'ansi)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Anxiety; Palliative Care; Music Therapy
• Intervention / Treatment: Other: depression management; Other: questionnaire; Other: Kigonki

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Oncle, MD; Phone Number: 33+03 22 45 64 43; Email: Oncle.julie@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • CHRU Amiens
    • Principal Investigator: Brassaint, MD
    • Principal Investigator: Anne VANBESIEN, MD
    • Principal Investigator: Sophie RIVENQ, MD
    • Principal Investigator: Isabelle QUENTIN, MD
    • Principal Investigator: Laurence BIRKUI, MD
    • Principal Investigator: MEROT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years
• Patient hospitalized in palliative care unit for oncological pathology
• Presenting an anxiety score > 46 (according to the STAI-Y State scale)
• Whose subsequent hospitalization is estimated to last more than three weeks
• No deafness likely to interfere with a receptive music therapy session (no difficulty in understanding whispered speech).
• Affiliated with a social security scheme
• Have signed the consent form for the study

Exclusion Criteria:

• Deafness without hearing aids
• Patients under guardianship, curatorship or safeguard of justice
• Pregnant or breast-feeding
• Not affiliated to a social security scheme
• Patient with an aversion to the sounds produced by the Kigonki

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group without music therapy; Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.; 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.; Evaluation of quality of life at last assessment	Other: depression management; - Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.; 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.
Experimental: Music therapy group; Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.; Six 30-minute sessions of receptive ISM with Kigonki according to study protocol; Assessment of the 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. Tri-weekly assessments will be repeated 30 minutes after each ISM session. - Evaluation of quality of life at last assessment	Other: depression management; - Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.; 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.; Other: Kigonki; Six 30-minute sessions of receptive ISM with Kigonki according to study protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in anxiety score obtained using the STAI-Y State scale	The State-Trait Anxiety Inventory (STAI), specifically Form Y (STAI-Y), stands as one of the most widely utilized self-report measures in psychological and medical research for the quantitative assessment of anxiety. The STAI-Y operationalizes the psychological construct of anxiety as having two independent dimensions, each measured by 20 items for a total of 40 items in the complete inventory. State Anxiety (A-State) is defined as a transient emotional response characterized by immediate, subjective feelings of tension, apprehension, worry, and physiological activation of the autonomic nervous system. Respondents assess their feelings "right now, at this moment" using a 4-point intensity scale. In contrast, Trait Anxiety (A-Trait) refers to stable individual differences in anxiety proneness. Individuals scoring high in A-Trait are predisposed to perceive a broader range of situations as threatening and are likely to react to these situations with elevated A-State responses. A-Trait	1 week
change in anxiety score obtained using the STAI-Y State scale	The State-Trait Anxiety Inventory (STAI), specifically Form Y (STAI-Y), stands as one of the most widely utilized self-report measures in psychological and medical research for the quantitative assessment of anxiety. The STAI-Y operationalizes the psychological construct of anxiety as having two independent dimensions, each measured by 20 items for a total of 40 items in the complete inventory. State Anxiety (A-State) is defined as a transient emotional response characterized by immediate, subjective feelings of tension, apprehension, worry, and physiological activation of the autonomic nervous system. Respondents assess their feelings "right now, at this moment" using a 4-point intensity scale. In contrast, Trait Anxiety (A-Trait) refers to stable individual differences in anxiety proneness. Individuals scoring high in A-Trait are predisposed to perceive a broader range of situations as threatening and are likely to react to these situations with elevated A-State responses. A-Trait	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
PANAS questionnaire (Positive and Negative Affect Scale)	30 minutes after the session
Variations in scores of the STAI-Y ETAT scale	30 minutes after the session
pulse variation	30 minutes after the session
BP variation	30 minutes after the session
respiratory rate	30 minutes after the session
PANAS questionnaire (Positive and Negative Affect Scale)	one week after the 6th session
Variations in scores of the STAI-Y ETAT scale	one week after the 6th session
pulse variation	one week after the 6th session
BP variation	one week after the 6th session
respiratory rate	one week after the 6th session

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Centre Hospitalier de Beauvais; Centre Hospitalier de Bethune; Centre Hospitalier de Douai; Hospital of Lens; GHPSO site de Senlis; CH de Compiegne

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 8, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: palliative care; cancer; anxiety; Music therapy
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Anxiety Disorders; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: PI2025_843_0176

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