Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05015140 |
| Other study ID # |
HSCT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
May 31, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Istanbul University-Cerrahpasa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
