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

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Effects of Music Therapy in Controlling Symptoms in Patients With Acute Myeloblastic Leukemia and Undergoing Hematopoietic Stem Cell Transplantation: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05696457
• Other study ID #: EC086-20
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: November 21, 2022

Study information

• Verified date: January 2023
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloblastic Leukemia
• Hematopoietic Stem Cell Transplantation
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Instituto Investigacion Sanitaria Fundacion Jimenez Diaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical and psychological symptom burden	Edmonton Symptom Assessment System (ESAS) global score (0 to 110 points, higher scores mean higher symptom burden)	The ESAS global score is measured before and after the daily music therapy session (from date of randomization until the date of discharge, up to 8 weeks)
Secondary	Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS) score	HADS score (0 to 42 points, higher scores mean higher anxiety/depression)	Once a week (from date of randomization until the date of discharge, up to 8 weeks)
Secondary	Quality of life assessed by the Functional Assessment of Cancer Therapy - General (FACT-G) score	FACT-G score (0 to 108 points, higher scores mean better quality of life)	Once a week (from date of randomization until the date of discharge, up to 8 weeks)