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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 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

84

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Francia
      • Amiens, Francia, 80480
        • CHRU Amiens
        • Investigatore principale:
          • Brassaint, MD
        • Investigatore principale:
          • Anne VANBESIEN, MD
        • Investigatore principale:
          • Sophie RIVENQ, MD
        • Investigatore principale:
          • Isabelle QUENTIN, MD
        • Investigatore principale:
          • Laurence BIRKUI, MD
        • Investigatore principale:
          • MEROT, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Altro: depression management
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
Altro: 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.
Sperimentale: 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
Altro: depression management
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
Altro: 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.
Altro: Kigonki
Six 30-minute sessions of receptive ISM with Kigonki according to study protocol

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
change in anxiety score obtained using the STAI-Y State scale
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
PANAS questionnaire (Positive and Negative Affect Scale)
Lasso di tempo: 30 minutes after the session
30 minutes after the session
Variations in scores of the STAI-Y ETAT scale
Lasso di tempo: 30 minutes after the session
30 minutes after the session
pulse variation
Lasso di tempo: 30 minutes after the session
30 minutes after the session
BP variation
Lasso di tempo: 30 minutes after the session
30 minutes after the session
respiratory rate
Lasso di tempo: 30 minutes after the session
30 minutes after the session
PANAS questionnaire (Positive and Negative Affect Scale)
Lasso di tempo: one week after the 6th session
one week after the 6th session
Variations in scores of the STAI-Y ETAT scale
Lasso di tempo: one week after the 6th session
one week after the 6th session
pulse variation
Lasso di tempo: one week after the 6th session
one week after the 6th session
BP variation
Lasso di tempo: one week after the 6th session
one week after the 6th session
respiratory rate
Lasso di tempo: one week after the 6th session
one week after the 6th session

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaboratori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 aprile 2028

Completamento dello studio (Stimato)

1 aprile 2028

Date di iscrizione allo studio

Primo inviato

21 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 settembre 2026

Primo Inserito (Effettivo)

8 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 settembre 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PI2025_843_0176

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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