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NCT Number: NCT07806435

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

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.

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Key information

Conditions

Music Therapy Anxiety Anxiety Disorders Cancer Mental Disorders Neoplasms Palliative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Amiens

Amiens, 80480, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

depression management

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

Kigonki

Other

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

Questionnaire

Other

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.

Primary outcomes

  1. change in anxiety score obtained using the STAI-Y State scale

    Time frame: 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

  2. change in anxiety score obtained using the STAI-Y State scale

    Time frame: 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

Secondary outcomes

  1. PANAS questionnaire (Positive and Negative Affect Scale)

    Time frame: 30 minutes after the session

  2. Variations in scores of the STAI-Y ETAT scale

    Time frame: 30 minutes after the session

  3. pulse variation

    Time frame: 30 minutes after the session

  4. BP variation

    Time frame: 30 minutes after the session

  5. respiratory rate

    Time frame: 30 minutes after the session

  6. PANAS questionnaire (Positive and Negative Affect Scale)

    Time frame: one week after the 6th session

  7. Variations in scores of the STAI-Y ETAT scale

    Time frame: one week after the 6th session

  8. pulse variation

    Time frame: one week after the 6th session

  9. BP variation

    Time frame: one week after the 6th session

  10. respiratory rate

    Time frame: one week after the 6th session

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

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

Registry information

Acronym: CessataEl'ansi

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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