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

NCT ID: NCT02639169

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-11-30

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.

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.

Conditions

Mood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

music

Apply live music through techniques music therapy in group experimental and evaluation through the visual analog scale (VAS) and numeric.

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: OTHER

apply live music through the techniques of music therapy

Comparative

Apply the visual analog scale (VAS) and numeric.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music Therapy

apply live music through the techniques of music therapy

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Paraná

OTHER

Sponsor Role: lead

Responsible Party

Carlos Antonio Dóro

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Doro, Student

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Parana

References

BRUSCIA K. E. Definindo a Musicoterapia. Rio de Janeiro, Ed. Enelivros - 2000.

Reference Type: BACKGROUND

Jacobsen PB, Donovan KA, Trask PC, Fleishman SB, Zabora J, Baker F, Holland JC. Screening for psychologic distress in ambulatory cancer patients. Cancer. 2005 Apr 1;103(7):1494-502. doi: 10.1002/cncr.20940.

Reference Type: BACKGROUND

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Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.

Reference Type: BACKGROUND

PMID: 14622683 (View on PubMed)

MACHADO, L.N; CAMANDONI, V.O; HARO LEAL K.P; MOSCATELLO, E.L.M. Transplante de Medula Óssea Abordagem Multidisciplinar São Paulo Lemar 2009

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

PETERSEN, E.M; Revista do Hospital Universitario Pedro Ernesto UERJ - 2012

Reference Type: BACKGROUND

Bradt J, Dileo C, Grocke D, Magill L. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database Syst Rev. 2011 Aug 10;(8):CD006911. doi: 10.1002/14651858.CD006911.pub2.

Reference Type: RESULT

PMID: 21833957 (View on PubMed)

Ratcliff CG, Prinsloo S, Richardson M, Baynham-Fletcher L, Lee R, Chaoul A, Cohen MZ, de Lima M, Cohen L. Music therapy for patients who have undergone hematopoietic stem cell transplant. Evid Based Complement Alternat Med. 2014;2014:742941. doi: 10.1155/2014/742941. Epub 2014 Jan 9.

Reference Type: RESULT

PMID: 24527052 (View on PubMed)

Raglio A, Attardo L, Gontero G, Rollino S, Groppo E, Granieri E. Effects of music and music therapy on mood in neurological patients. World J Psychiatry. 2015 Mar 22;5(1):68-78. doi: 10.5498/wjp.v5.i1.68.

Reference Type: RESULT

PMID: 25815256 (View on PubMed)

Other Identifiers

26404414.9.0000.0096

Identifier Type: -

Identifier Source: org_study_id