Effects of Music Therapy in Controlling Symptoms in Patients With AML and Undergoing HSCT
NCT ID: NCT05696457
Last Updated: 2023-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2021-02-01
2022-11-21
Brief Summary
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\- Can music therapy control physical and psychological symptoms and improve the mood and quality of life of these patients?
Participants will be randomly assigned to the control and experimental group. Patients included in both groups will complete weekly mood and quality of life questionnaires. Those included in the experimental group will also complete daily symptom burden questionnaires before and after listening to a music therapy session.
Researchers will confirm if the experimental group improves their symptoms after the music therapy session and will compare both groups to see if there are differences in mood and quality of life.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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AML-E
Acute myeloblastic leukemia - experimental
Passive music therapy
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
AML-C
Acute myeloblastic leukemia - control
No interventions assigned to this group
AlloSCT-E
Allogeneic stem cell transplantation - experimental
Passive music therapy
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
AlloSCT-C
Allogeneic stem cell transplantation - control
No interventions assigned to this group
AutoSCT-E(I)
Autologous stem cell transplantation - experimental (inpatient)
Passive music therapy
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
AutoSCT-C(I)
Autologous stem cell transplantation - control (inpatient)
No interventions assigned to this group
AutoSCT-E(O)
Autologous stem cell transplantation - experimental (outpatient)
Passive music therapy
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
AutoSCT-C(O)
Autologous stem cell transplantation - control (outpatient)
No interventions assigned to this group
Interventions
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Passive music therapy
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
Eligibility Criteria
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Inclusion Criteria
* Patients receiving induction chemotherapy for a newly diagnosed acute myeloblastic leukemia (except for acute promyelocytic leukemia).
* Patients undergoing autologous or allogeneic stem cell transplantation.
* Being able to understand and read Spanish properly.
* Basic computer skills.
Exclusion Criteria
* Past history of psychiatric disorders.
* Performance status: ECOG ≥ 3.
18 Years
ALL
No
Sponsors
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER
Responsible Party
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Principal Investigators
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Alberto Lázaro García, MD
Role: PRINCIPAL_INVESTIGATOR
Fundación Jiménez Díaz University Hospital
Locations
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Instituto Investigacion Sanitaria Fundacion Jimenez Diaz
Madrid, , Spain
Countries
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References
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Lazaro-Garcia A, Lainez-Gonzalez D, Gonzalez-Rodriguez M, Cano Alsua S, Suarez M EU, Solan-Blanco L, Cornago-Navascues J, Lopez-Lorenzo JL, Llamas-Sillero P, Alonso-Dominguez JM. Music Listening in Stem Cell Transplantation and Acute Myeloid Leukemia: A Randomized Clinical Trial. J Pain Symptom Manage. 2024 Jun;67(6):501-511.e12. doi: 10.1016/j.jpainsymman.2024.02.567. Epub 2024 Mar 4.
Other Identifiers
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EC086-20
Identifier Type: -
Identifier Source: org_study_id
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