Music TherapyCessataEl'ansiNCT07806435
Evaluation of the Effectiveness of Music Therapy on Anxiety Levels in Patients With Advanced Cancer Hospitalized in a Palliative Care Unit
A study testing depression management, Kigonki and questionnaire in people with Music Therapy and Palliative Care, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Music Therapy, Palliative Care, Cancer
- What is being tested?
- depression management, Kigonki and questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Music Therapy, Palliative Care, Cancer, Anxiety
- Being tested
- depression management, Kigonki, questionnaire
- Keywords
- anxiety, Music therapy, palliative care, cancer
- Medical subject headings
- Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depression managementOther
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
KigonkiOther
Six 30-minute sessions of receptive ISM with Kigonki according to study protocol
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: depression management; Other: 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 Receives: Other: depression management; Other: Kigonki; Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 weeks
Secondary outcomes (10)
PANAS questionnaire (Positive and Negative Affect Scale)
Measured: 30 minutes after the session
Variations in scores of the STAI-Y ETAT scale
Measured: 30 minutes after the session
pulse variation
Measured: 30 minutes after the session
BP variation
Measured: 30 minutes after the session
respiratory rate
Measured: 30 minutes after the session
PANAS questionnaire (Positive and Negative Affect Scale)
Measured: one week after the 6th session
Variations in scores of the STAI-Y ETAT scale
Measured: one week after the 6th session
pulse variation
Measured: one week after the 6th session
BP variation
Measured: one week after the 6th session
respiratory rate
Measured: one week after the 6th session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Bethune, Centre Hospitalier de Douai, Hospital of Lens, GHPSO site de Senlis, CH de Compiegne, Centre Hospitalier de Beauvais
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806435
- Sponsor's protocol ID
- PI2025_843_0176
- Acronym
- CessataEl'ansi
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Music Therapy on Anxiety Levels in Patients With Advanced Cancer Hospitalized in a Palliative Care Unit
- ClinicalTrials.gov ID
- NCT07806435
- Acronym / sponsor ID
- CessataEl'ansi / PI2025_843_0176
- Conditions
- Music Therapy, Palliative Care, Cancer, Anxiety
- Keywords
- anxiety, Music therapy, palliative care, cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Bethune, Centre Hospitalier de Douai, Hospital of Lens, GHPSO site de Senlis, CH de Compiegne, Centre Hospitalier de Beauvais
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group without music therapy | Active comparator | Other: depression management, Other: questionnaire* 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 |
| Music therapy group | Experimental | Other: depression management, Other: Kigonki, Other: questionnaire* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| depression management- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center. | Other | Group without music therapy, Music therapy group |
| KigonkiSix 30-minute sessions of receptive ISM with Kigonki according to study protocol | Other | Music therapy group |
| questionnaireAssessment 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. | Other | Group without music therapy, Music therapy group |
Primary outcome
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
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
10 secondary outcomes
PANAS questionnaire (Positive and Negative Affect Scale)
Time frame: 30 minutes after the session
Variations in scores of the STAI-Y ETAT scale
Time frame: 30 minutes after the session
pulse variation
Time frame: 30 minutes after the session
BP variation
Time frame: 30 minutes after the session
respiratory rate
Time frame: 30 minutes after the session
PANAS questionnaire (Positive and Negative Affect Scale)
Time frame: one week after the 6th session
Variations in scores of the STAI-Y ETAT scale
Time frame: one week after the 6th session
pulse variation
Time frame: one week after the 6th session
BP variation
Time frame: one week after the 6th session
respiratory rate
Time frame: one week after the 6th session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing depression management, Kigonki and questionnaire in people with Music Therapy and Palliative Care, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Oncle, MD (33+03 22 45 64 43, Oncle.julie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in anxiety score obtained using the STAI-Y State scale (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.