Clinical trial · Interventional
Evaluation of the Effectiveness of Music Therapy on Anxiety Levels in Patients With Advanced Cancer Hospitalized in a Palliative Care Unit
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Music Therapy | — | UNRESOLVED | — |
| Palliative Care | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| depression management | Other | — | UNRESOLVED |
| Kigonki | Other | — | UNRESOLVED |
| questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group without music therapy
- description
- * 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
- interventionNames
- Other: depression management
- Other: questionnaire
- type
- EXPERIMENTAL
- label
- Music therapy group
- description
- * 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
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available