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Completed

NCT Number: NCT05696457

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

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.

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Key information

Conditions

Acute Myeloblastic Leukemia Hematologic Diseases Hematopoietic Stem Cell Transplantation Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Investigacion Sanitaria Fundacion Jimenez Diaz

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Passive music therapy

Behavioral

Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.

Primary outcomes

  1. Change in physical and psychological symptom burden

    Time frame: 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)

    Edmonton Symptom Assessment System (ESAS) global score (0 to 110 points, higher scores mean higher symptom burden)

Secondary outcomes

  1. Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS) score

    Time frame: Once a week (from date of randomization until the date of discharge, up to 8 weeks)

    HADS score (0 to 42 points, higher scores mean higher anxiety/depression)

  2. Quality of life assessed by the Functional Assessment of Cancer Therapy - General (FACT-G) score

    Time frame: Once a week (from date of randomization until the date of discharge, up to 8 weeks)

    FACT-G score (0 to 108 points, higher scores mean better quality of life)

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2023
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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