NCT05015140

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 11, 2021

Last Update Submit

August 19, 2021

Conditions

Keywords

hematopoietic stem cell transplant, music therapy, sleep quality

Outcome Measures

Primary Outcomes (1)

  • Richard Campbell Sleep Questionnaire

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

    10 days

Study Arms (2)

experiment group

EXPERIMENTAL

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

control group

NO INTERVENTION

\- 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.

Interventions

calm music with nature sounds set by the music therapist

experiment group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be conscious
  • hospitalization for hematopoietic stem cell transplantation

You may not qualify if:

  • Deaf
  • Terminal period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul University-Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

İstanbul University- Cerrahpaşa

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hematologic DiseasesSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 20, 2021

Study Start

December 1, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations