Music Therapy Improves the Mood of Patients Undergoing Hematopoietic Stem Cells Transplantation
Condition: Mood
Study type: Interventional

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.
    

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.
    

Intervention name(s): Music Therapy
Intervention type(s): Other
Intervention description(s): apply live music through the techniques of music therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: music therapy; Distress; Mood; HSCT