NCT07806435

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Apr 2028

First Submitted

Initial submission to the registry

July 21, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

September 8, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

July 21, 2026

Last Update Submit

September 3, 2026

Conditions

Music TherapyPalliative CareCancerAnxiety

Keywords

anxietyMusic therapypalliative carecancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Group without music therapy

ACTIVE COMPARATOR

* 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 managementOther: questionnaire

Music therapy group

EXPERIMENTAL

* 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 managementOther: KigonkiOther: questionnaire

Interventions

depression managementOTHER

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

Group without music therapyMusic therapy group
KigonkiOTHER

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

Music therapy group
questionnaireOTHER

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.

Group without music therapyMusic therapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

NeoplasmsAnxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Julie Oncle, MD

CONTACT

33+03 22 45 64 43Oncle.julie@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2026

First Posted

September 8, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

September 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)