NCT02639169

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 24, 2015

Completed
Last Updated

August 18, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

December 10, 2015

Last Update Submit

August 16, 2016

Conditions

Keywords

music therapyDistressMoodHSCT

Outcome Measures

Primary Outcomes (1)

  • Mood

    The Mann Whitney test Showed statistical of significance p \<0.05

    "1 year"

Study Arms (2)

music

EXPERIMENTAL

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

Other: Music Therapy

Comparative

NO INTERVENTION

Apply the visual analog scale (VAS) and numeric.

Interventions

apply live music through the techniques of music therapy

music

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

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

    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.

    PMID: 15726544BACKGROUND
  • 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.

    PMID: 14622683BACKGROUND
  • MACHADO, L.N; CAMANDONI, V.O; HARO LEAL K.P; MOSCATELLO, E.L.M. Transplante de Medula Óssea Abordagem Multidisciplinar São Paulo Lemar 2009

    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

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

    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.

  • 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.

  • 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.

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Carlos Doro, Student

    Universidade Federal do Parana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2015

First Posted

December 24, 2015

Study Start

January 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

August 18, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Result of data collected during the research in tables calculated by a statistical