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

January 27, 2023 updated by: Özlem Canbolat, Gazi University

TC Gazi University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Music Application Group
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.
Other: Music Application
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.
NO_INTERVENTION: Control 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Richard - Campbell Sleep Questionnaire
Time Frame: a day before the music application
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.
a day before the music application
Richard - Campbell Sleep Questionnaire
Time Frame: after music application, 8th day
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.
after music application, 8th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2023

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ozlem Canbolat

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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