Effects of Music Therapy in Controlling Symptoms in Patients With AML and Undergoing HSCT

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status: Completed

Conditions: Acute Myeloblastic Leukemia; Hematopoietic Stem Cell Transplantation

Treatments: Behavioral: Passive music therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05696457

EC086-20

Details and patient eligibility

About

The goal of this clinical trial is to test passive music therapy in patients receiving induction chemotherapy for an acute myeloblastic leukemia or undergoing an hematopoietic stem cell transplantation. The main questions it aims to answer are:

• 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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years old.
• 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

• Moderate-severe hearing impairment (unilateral or bilateral).
• Past history of psychiatric disorders.
• Performance status: ECOG ≥ 3.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 8 patient groups

AML-E

Experimental group

Description:

Acute myeloblastic leukemia - experimental

Treatment:

Behavioral: Passive music therapy

AML-C

No Intervention group

Description:

Acute myeloblastic leukemia - control

AlloSCT-E

Experimental group

Description:

Allogeneic stem cell transplantation - experimental

Treatment:

Behavioral: Passive music therapy

AlloSCT-C

No Intervention group

Description:

Allogeneic stem cell transplantation - control

AutoSCT-E(I)

Experimental group

Description:

Autologous stem cell transplantation - experimental (inpatient)

Treatment:

Behavioral: Passive music therapy

AutoSCT-C(I)

No Intervention group

Description:

Autologous stem cell transplantation - control (inpatient)

AutoSCT-E(O)

Experimental group

Description:

Autologous stem cell transplantation - experimental (outpatient)

Treatment:

Behavioral: Passive music therapy

AutoSCT-C(O)

No Intervention group

Description:

Autologous stem cell transplantation - control (outpatient)