Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Music Therapy Improves the Mood of Patients Undergoing Hematopoietic Stem Cells Transplantation (MTHSCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639169
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Carlos Antonio Dóro, Universidade Federal do Paraná

Brief Summary:

ABSTRACT The transplant allogeneic hematopoietic stem cell transplantation (HSCT Alo) is a therapeutic medical treatment carried out in combat various neoplastic hematologic disorders, congenital, genetic or acquired. In this procedure, which combines high-dose chemotherapy and or radiation and has a degree of high cytotoxicity, the patient goes for a social solitary confinement, which causes psychological distress, pain, anxiety, mood disorders and can lead to depression. The music therapy was applied and the purpose of decreasing the insulation. This is a randomized controlled study.

Method: Apply the intervention of live music sessions through the techniques of music therapy; assess and quantify through the visual analog scale (VAS) and numeric. The dependent variables, pain, anxiety and mood of the participants selected randomly for the experimental group music therapy (EGM) n=50, and compare with the control group (CG) n=50, which received only the standard treatment.


Condition or disease Intervention/treatment Phase
Mood Other: Music Therapy Not Applicable

Detailed Description:

METHODOLOGY Study Design. It is a randomized controlled experimental study Place: Clinical Hospital Complex of the Federal University of Parana, Bone Marrow Transplant Service. The research was developed in the period Jan/2014 to November/2015.

Population: Adult patients undergoing hematopoietic stem cell transplantation (HSCT) Allogeneic. Approved by the Ethics Committee in Research of the University Federal of Paraná Clinical Hospital Complex, Presentation certificate for consideration Ethics: 26404414.9.0000.0096 Sample Calculation: The calculation of sample size was based on a previous pilot study for which was identified an average of 5.4 for the score of humor with standard deviation of 1.9. It was felt that this group corresponds to the control group of the new study and a minimal difference in the score of humor 1 point higher in the experimental group would be clinically relevant. For a significance level of 5% and a 80% test power, would take at least 45 cases in each group (Control and Experimental). Depending on the evaluation of mood score is given by an ordinal scale, it is suggested a 10% increase in the sample size in each group. Thus, 50 patients were needed in each group. the calculation of the sample was done by statistical.

Randomization: It was made random and concealed allocation of participants in the groups as follows: A Contributor not involved with the research played a given and communicated the number randomly selected to the researcher, the number was pair, and would compose the experimental group of music therapy. If it was odd participant would make up the control group. The evaluation was done by an external student of psychology. For musical intervention was not possible to apply the principle of double blind but, the evaluator did not know what kind of intervention was applied. The interventions were applied twice a week on Tuesdays and Thursdays from 9:00 am to 12:00 pm. in the morning and the assessment on the same day but the afternoon.

METHOD Apply live music through the music therapy techniques such as re-creation, improvisation and rhythmic production, the experimental group of music therapy (EGM).

Implement and measure through the visual analog scale (VAS) and numeric the level of mood, anxiety and pain in the experimental group music therapy (EGM).

Apply the visual analog scale (VAS) and numeric to measure the levels of Mood, Anxiety and Pain Control Group (GC) that received only the standard treatment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Music Therapy on Mood Control in Hospitalized Patients for Transplantation of Hematopoietic Stem Cells
Study Start Date : January 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: music
Apply live music through techniques music therapy in group experimental and evaluation through the visual analog scale (VAS) and numeric.
Other: Music Therapy
apply live music through the techniques of music therapy

No Intervention: Comparative
Apply the visual analog scale (VAS) and numeric.



Primary Outcome Measures :
  1. Mood [ Time Frame: "1 year" ]
    The Mann Whitney test Showed statistical of significance p <0.05



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • The invitation was made to each patient submitted to (HSCT Alo) with aged between 18 and 65 years.
  • If the patient accepted to participate in the research should sign a free and informed consent form (ICF)

EXCLUSION CRITERIA:

  • All patients who did not undergoing allogeneic transplantation were excluded also in case of opting out of the search
  • All minors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639169


Sponsors and Collaborators
Universidade Federal do Paraná
Investigators
Layout table for investigator information
Principal Investigator: Carlos Doro, Student Universidade Federal do Parana
Publications of Results:
Other Publications:
BRUSCIA K. E. Definindo a Musicoterapia. Rio de Janeiro, Ed. Enelivros - 2000.
MACHADO, L.N; CAMANDONI, V.O; HARO LEAL K.P; MOSCATELLO, E.L.M. Transplante de Medula Óssea Abordagem Multidisciplinar São Paulo Lemar 2009
ORTEGA, E.T.T; KOJO, T.K; DE LIMA, D.H; VERAN, M.P; NEVES, M. I. Compêndio de Enfermagem em Transplante de Células-Tronco Hematopoéticas Editora Maio Curitiba 2004
PETERSEN, E.M; Revista do Hospital Universitario Pedro Ernesto UERJ - 2012

Layout table for additonal information
Responsible Party: Carlos Antonio Dóro, Principal Investigator, Universidade Federal do Paraná
ClinicalTrials.gov Identifier: NCT02639169    
Other Study ID Numbers: 26404414.9.0000.0096
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Result of data collected during the research in tables calculated by a statistical
Keywords provided by Carlos Antonio Dóro, Universidade Federal do Paraná:
music therapy
Distress
Mood
HSCT