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Effects of Music Therapy on Sleep Quality in Patients Who Had Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT05015140
Recruitment Status : Completed
First Posted : August 20, 2021
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Sumeyye Can, Istanbul University-Cerrahpasa

Brief Summary:

In patients undergoing hematopoietic stem cell transplant; Side effects associated with high-dose chemotherapy and radiotherapy, night treatment and care, social isolation cause emotional problems and deterioration in sleep quality in this patient population. In a meta-analysis conducted in 2014, it was reported that music can be effective in improving sleep quality.

In this study, an experimental design with pre-test - post-test control group will be used to evaluate the effect of music therapy on sleep quality given to patients undergoing hematopoietic stem cell transplantation. It will be held between December 2020 and May 2021 at the Bone Marrow Transplantation Unit of Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Hospital. The population of the study will be the patients hospitalized in the unit within the specified date range and the sample number was determined as 30.


Condition or disease Intervention/treatment Phase
Hematologic Diseases Other: musıc therapy Not Applicable

Detailed Description:

Research Universe and Sample:

The population of the study will be the patients who applied to the Bone Marrow Transplantation Unit of Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Hospital between December 2020 - May 2021 and accepted the study. Considering the previous years in the date range of the study, it is predicted that an average of 25 patients will be hospitalized for stem cell transplantation. In a study conducted in 2014, it was reported that sleep disturbance continued in the long term after the transplantation in half of the patients who underwent hematopoietic stem cell transplantation. In the light of this information, the sample size was calculated as 24 using the OpenEpi program. Considering the possibility of patient or treatment-related disruptions during the study, it was planned to include 30 patients, 15 of which were experimental and 15 were control group.

Data Collection Tools The age, gender, type of transplant, habits and sleep of the patients created by the researcher during the data collection phase.

The "Patient Identification Form", which consists of 14 questions related to patients such as problems, and developed by Richards in 1987, was developed by Karaman Özlü et al. "Richard Campbell Sleep Questionnaire", whose validity and reliability study has been made, will be used.

Musical Intervention

In determining the music to be used, a quiet music containing the sounds of nature was determined in consultation with the music therapist.

It will be applied to the experimental group by using an mp3 player in the patient room, starting on the day before the transfer (D-1), every evening for 10 days and each session for 30 minutes. It will be applied between 23:00 and 24:00 in the evening so as not to prevent the standard treatment and care of the patients. After 10 days, the sleep quality of the patients will be re-evaluated using the Richard Campbell Sleep Questionnaire.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Music Therapy on Sleep Quality in Patients Who Had Hematopoietic Stem Cell Transplantation
Actual Study Start Date : December 1, 2020
Actual Primary Completion Date : May 31, 2021
Actual Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Arm Intervention/treatment
Experimental: experiment group
The first day before the application of music to each of the 15 patients in the experimental group (D-1) 'Patient Identification First evaluation will be made by filling the form "and then the" Richard Campbell Sleep Questionnaire ". The day before transplant (D-1) Starting from 10 days, calm music including nature sounds determined by the music therapist will be played using mp3 player. The Richard Campbell Sleep questionnaire will be filled again on the 10th day (D + 10) after the transplant.
Other: musıc therapy
calm music with nature sounds set by the music therapist

No Intervention: control group

- The day before the transplant (D-1) for each of the 15 patients in the control group, first 'Patient Identification Form' and then 'Richard The first evaluations will be made by filling the Campbell Sleep Questionnaire, and standard treatment and care interventions will be given to the patients in this group.

The sleep questionnaire was filled out again on the tenth day (D + 10) after the transplant without any intervention.




Primary Outcome Measures :
  1. Richard Campbell Sleep Questionnaire [ Time Frame: 10 days ]
    Evaluation of the change in sleep quality from baseline with the Richard Campbell sleep questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria in the study;

  • To be conscious
  • hospitalization for hematopoietic stem cell transplantation

Exclusion criteria;

  • Deaf
  • Terminal period

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): NCT05015140


Locations
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Turkey
İstanbul University- Cerrahpaşa
Istanbul, Turkey, 34098
Istanbul University-Cerrahpasa
Istanbul, Turkey, 34098
Sponsors and Collaborators
Istanbul University-Cerrahpasa
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Responsible Party: Sumeyye Can, Nurse, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT05015140    
Other Study ID Numbers: HSCT
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sumeyye Can, Istanbul University-Cerrahpasa:
hematopoietic stem cell transplant, music therapy, sleep quality
Additional relevant MeSH terms:
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Hematologic Diseases