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

Primary Purpose

Hematologic Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
musıc therapy
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hematologic Diseases focused on measuring hematopoietic stem cell transplant, music therapy, sleep quality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria in the study;

  • To be conscious
  • hospitalization for hematopoietic stem cell transplantation

Exclusion criteria;

  • Deaf
  • Terminal period

Sites / Locations

  • İstanbul University- Cerrahpaşa
  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experiment group

control group

Arm Description

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.

- 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.

Outcomes

Primary Outcome Measures

Richard Campbell Sleep Questionnaire
Evaluation of the change in sleep quality from baseline with the Richard Campbell sleep questionnaire.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2021
Last Updated
August 19, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05015140
Brief Title
Effects of Music Therapy on Sleep Quality in Patients Who Had Hematopoietic Stem Cell Transplantation
Official Title
Effects of Music Therapy on Sleep Quality in Patients Who Had Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases
Keywords
hematopoietic stem cell transplant, music therapy, sleep quality

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experiment group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
- 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.
Intervention Type
Other
Intervention Name(s)
musıc therapy
Intervention Description
calm music with nature sounds set by the music therapist
Primary Outcome Measure Information:
Title
Richard Campbell Sleep Questionnaire
Description
Evaluation of the change in sleep quality from baseline with the Richard Campbell sleep questionnaire.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria in the study; To be conscious hospitalization for hematopoietic stem cell transplantation Exclusion criteria; Deaf Terminal period
Facility Information:
Facility Name
İstanbul University- Cerrahpaşa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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