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

3 septembre 2026 mis à jour par: Centre Hospitalier Universitaire, Amiens
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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

84

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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
Autre: depression management
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
Autre: 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.
Expérimental: 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
Autre: depression management
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
Autre: 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.
Autre: Kigonki
Six 30-minute sessions of receptive ISM with Kigonki according to study protocol

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
change in anxiety score obtained using the STAI-Y State scale
Délai: 1 week

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
Délai: 2 weeks

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

Mesures de résultats secondaires

Mesure des résultats
Délai
PANAS questionnaire (Positive and Negative Affect Scale)
Délai: 30 minutes after the session
30 minutes after the session
Variations in scores of the STAI-Y ETAT scale
Délai: 30 minutes after the session
30 minutes after the session
pulse variation
Délai: 30 minutes after the session
30 minutes after the session
BP variation
Délai: 30 minutes after the session
30 minutes after the session
respiratory rate
Délai: 30 minutes after the session
30 minutes after the session
PANAS questionnaire (Positive and Negative Affect Scale)
Délai: one week after the 6th session
one week after the 6th session
Variations in scores of the STAI-Y ETAT scale
Délai: one week after the 6th session
one week after the 6th session
pulse variation
Délai: one week after the 6th session
one week after the 6th session
BP variation
Délai: one week after the 6th session
one week after the 6th session
respiratory rate
Délai: one week after the 6th session
one week after the 6th session

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Centre Hospitalier Universitaire, Amiens

Collaborateurs

Centre Hospitalier de Beauvais
Centre Hospitalier de Bethune
Centre Hospitalier de Douai
Hospital of Lens
GHPSO site de Senlis
CH de Compiegne

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 avril 2028

Achèvement de l'étude (Estimé)

1 avril 2028

Dates d'inscription aux études

Première soumission

21 juillet 2026

Première soumission répondant aux critères de contrôle qualité

3 septembre 2026

Première publication (Réel)

8 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PI2025_843_0176

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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