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

16. august 2016 oppdatert av: Carlos Antonio Dóro, Universidade Federal do Paraná

The Impact of Music Therapy on Mood Control in Hospitalized Patients for Transplantation of Hematopoietic Stem Cells

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: music
Apply live music through techniques music therapy in group experimental and evaluation through the visual analog scale (VAS) and numeric.
apply live music through the techniques of music therapy
Ingen inngripen: Comparative
Apply the visual analog scale (VAS) and numeric.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mood
Tidsramme: "1 year"
The Mann Whitney test Showed statistical of significance p <0.05
"1 year"

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Carlos Doro, Student, Universidade Federal do Parana

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2014

Primær fullføring (Faktiske)

1. november 2015

Studiet fullført (Faktiske)

1. november 2015

Datoer for studieregistrering

Først innsendt

10. desember 2015

Først innsendt som oppfylte QC-kriteriene

21. desember 2015

Først lagt ut (Anslag)

24. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. august 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 26404414.9.0000.0096

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

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