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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. september 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

84

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Amiens, Frankrig, 80480
        • CHRU Amiens
        • Ledende efterforsker:
          • Brassaint, MD
        • Ledende efterforsker:
          • Anne VANBESIEN, MD
        • Ledende efterforsker:
          • Sophie RIVENQ, MD
        • Ledende efterforsker:
          • Isabelle QUENTIN, MD
        • Ledende efterforsker:
          • Laurence BIRKUI, MD
        • Ledende efterforsker:
          • MEROT, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Andet: depression management
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
Andet: 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.
Eksperimentel: 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
Andet: depression management
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
Andet: 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.
Andet: Kigonki
Six 30-minute sessions of receptive ISM with Kigonki according to study protocol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in anxiety score obtained using the STAI-Y State scale
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire, Amiens

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. april 2028

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

21. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. september 2026

Først opslået (Faktiske)

8. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PI2025_843_0176

Plan for individuelle deltagerdata (IPD)

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