search
Back to results

The Effect of Music on Sleep Quality in Behçet's Patients

Primary Purpose

Sleep Quality, Behçet Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music Application
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Quality

Eligibility Criteria

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

Inclusion Criteria: 18 years or older Having been diagnosed with Behçet's Disease for at least 6 months A score of 0-25 on the Richard-Campbell Sleep Questionnaire No visual or hearing impairment Being literate Ability to understand and speak Turkish Having mental and cognitive competence Not having a psychiatric diagnosis It is voluntary to participate in the study. Not using sleeping pills Become an Android processor phone - Exclusion Criteria: Unreachable during phone calls with sleep apnea Chronic diseases that can affect sleep such as COPD, Asthma, Heart failure not continuing research Patients using sleeping pills -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Music Application Group

    Control Group

    Arm Description

    After explaining the purpose of the study and the way it was applied to behçet's patients in the music group, Introductory Information Form, Behçet's Syndrome Activity Scale (BSAS), Richards-Campbell Sleep Questionnaire (RCSQ) will be applied. Patients will listen to music composed in Uşşak makam for 50 minutes before going to bed every day for 7 days. After the first interview, the patients will be reminded of the music application by phone call and 2 text messages every day by the researcher. Interviews will be recorded on the Patient's Telephone Follow-up Form while Listening to Music. On the 8th day, the BSAS and RCSQ scales will be reapplied to the patients in the intervention group.

    After explaining the purpose of the study and the way it was applied to behçet's patients in the control group, Introductory Information Form, Behçet's Syndrome Activity Scale (BSAS), Richards-Campbell Sleep Questionnaire (RCSQ) will be applied.No application will be made to the control group. On the 8th day, the BSAS and RCSQ scales will be reapplied to the patients.

    Outcomes

    Primary Outcome Measures

    Richard - Campbell Sleep Questionnaire
    Scores from the scale range from 0 to 100, and the higher the score, the higher the sleep quality. "0-25" points poor sleep quality, "76-100" points good sleep quality.
    Richard - Campbell Sleep Questionnaire
    Scores from the scale range from 0 to 100, and the higher the score, the higher the sleep quality. "0-25" points poor sleep quality, "76-100" points good sleep quality.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 27, 2023
    Last Updated
    January 27, 2023
    Sponsor
    Gazi University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05715294
    Brief Title
    The Effect of Music on Sleep Quality in Behçet's Patients
    Official Title
    TC Gazi University
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 30, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gazi University

    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
    The aim of this study was to evaluate effect of music on sleep quality in patients with Behçet's disease. The population of the study consists of behçet patients who applied to the Rheumatology outpatient clinic of Medical Faculty Hospital, who met the research criteria and agreed to participate in the study. The study will conduct in a randomized controlled experimental design with two groups. The sample of the study will be 50 behçet patients the music practice group (25) and the control group (25). The research will be carried out between December 2022 and December 2023. In this study, data will with collect Descriptive Information Form, Behçet's Syndrome Activity Scale (BSAS) and Richard-Campbell Sleep Scale (RCUI).
    Detailed Description
    This study will be conducted as a parallel group randomized controlled experimental study to determine the effect of listening to music in the uşşak makam on sleep quality in Behçet's Diseases.The population of the research will be Behçet's patients receiving outpatient treatment in the Rheumatology outpatient clinic of a university hospital.G.Power program was used to calculate the sample size of the study. In descriptive studies, the t tests - Means: Difference between two independent means (two groups) model was used to determine the sample size when the number of individuals in the universe was not known. While determining the sample volume in the research, the test for the main hypothesis was determined at the first stage and the required averages were obtained from Bakır's research in 2019, which is compatible with our study in the literature (Bakır, 2019). According to the g-power analysis, with 95% confidence level and α=0.05 margin of error, it has an effect size of 0.941 and a tolerance ratio of 5%; In this study, the power of the test was determined as p: 0.05, (1-β): 90%, t = 2.015, and in line with this information, it was concluded that the number of samples required for the study was 46 people in both groups. Considering the possible losses from the experimental study, the number of samples was increased by 10% and it was decided that the total sample size would be 50 people, 25 people in the intervention group and 25 people in the control group.Application In this study, intervention and control groups will be studied in a pre-test and post-test design. No intervention will be applied to the control group. Passive music listening practice for the intervention group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Quality, Behçet Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Music Application Group
    Arm Type
    Experimental
    Arm Description
    After explaining the purpose of the study and the way it was applied to behçet's patients in the music group, Introductory Information Form, Behçet's Syndrome Activity Scale (BSAS), Richards-Campbell Sleep Questionnaire (RCSQ) will be applied. Patients will listen to music composed in Uşşak makam for 50 minutes before going to bed every day for 7 days. After the first interview, the patients will be reminded of the music application by phone call and 2 text messages every day by the researcher. Interviews will be recorded on the Patient's Telephone Follow-up Form while Listening to Music. On the 8th day, the BSAS and RCSQ scales will be reapplied to the patients in the intervention group.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    After explaining the purpose of the study and the way it was applied to behçet's patients in the control group, Introductory Information Form, Behçet's Syndrome Activity Scale (BSAS), Richards-Campbell Sleep Questionnaire (RCSQ) will be applied.No application will be made to the control group. On the 8th day, the BSAS and RCSQ scales will be reapplied to the patients.
    Intervention Type
    Other
    Intervention Name(s)
    Music Application
    Intervention Description
    A music CD was prepared within the scope of passive music listening practice. To determine the music, the researcher advice and literature knowledge of Turkish Music A music CD was prepared within the scope of passive music listening practice. To determine the music, the researcher advice and literature knowledge of Turkish Music Research and Promotion Society (TUMATA) was used. In the music application, the selecting instrumental music (ussak maqam which is Turkish Music Maqam) was used. The prepared Music CD will be played on the phones of patients with android processor phones. Patients will be told that they should listen to the music lying down and in a comfortable position, and that they should not use headphones while listening to music. Before going to bed, the patients will be listened to music composed in Ussak maqam for 50 minutes every day for 7 days.
    Primary Outcome Measure Information:
    Title
    Richard - Campbell Sleep Questionnaire
    Description
    Scores from the scale range from 0 to 100, and the higher the score, the higher the sleep quality. "0-25" points poor sleep quality, "76-100" points good sleep quality.
    Time Frame
    a day before the music application
    Title
    Richard - Campbell Sleep Questionnaire
    Description
    Scores from the scale range from 0 to 100, and the higher the score, the higher the sleep quality. "0-25" points poor sleep quality, "76-100" points good sleep quality.
    Time Frame
    after music application, 8th day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 years or older Having been diagnosed with Behçet's Disease for at least 6 months A score of 0-25 on the Richard-Campbell Sleep Questionnaire No visual or hearing impairment Being literate Ability to understand and speak Turkish Having mental and cognitive competence Not having a psychiatric diagnosis It is voluntary to participate in the study. Not using sleeping pills Become an Android processor phone - Exclusion Criteria: Unreachable during phone calls with sleep apnea Chronic diseases that can affect sleep such as COPD, Asthma, Heart failure not continuing research Patients using sleeping pills -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ozlem Canbolat, Assistant Professor
    Phone
    +903122162686
    Email
    ozlemcanbolat@gazi.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    The Effect of Music on Sleep Quality in Behçet's Patients

    We'll reach out to this number within 24 hrs