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The Effects of Education and Music Practice on Insomnia and Quality of Life

Primary Purpose

Insomnia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music Application
Sleep Hygiene Training
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Insomnia

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Those between the ages of 14-18, Receiving 15 points or more in AOS, Having no vision, hearing, or speech problems, Able to speak and write Turkish, No mental or neurological disability, Participating in the training program with the zoom program, Smartphone, using social media communication (WhatsApp), It was planned to include the adolescents who had the permission of themselves and their parents to participate in the study in the second phase of the study. Exclusion Criteria: Adolescents who want to withdraw from the study at any stage of the study will be excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Music Application Group

    Sleep Hygiene Training Group

    Control Group

    Arm Description

    After explaining the purpose of the study and the way it was applied to the adolescents in the music practice group, the Introductory Characteristics Form for Adolescents, PedsQL and AIQ will be applied. After, the predetermined instrumental music will be shared with the adolescents every evening for 15 days via social media by the researcher and participants will be asked to listen to these music. Participants will listen to the instrumental music sent by the researcher for at least 20 minutes every evening during the music application. This whole process will be reminded to the adolescents with messages every evening and they will be asked to listen the music before the normal bedtime (before 23:00 at night). At the end of the music application (after 15 days), the Introductory Characteristics Form for Adolescents, PedsQL and AIQ will be reapplied.

    After explaining the purpose of the study and the way it was applied to the adolescents in the music practice group, the Introductory Characteristics Form for Adolescents, the Pediatric Quality of Life Inventory (PedsQL) and Adolescent Insomnia Questionary (AIQ) will be applied. Adolescents in this group will be trained on Zoom for 4 weeks, 2 times a week, for 8 sessions (1 session 40 min). Sleep hygiene training prepared based on expert opinions and literature (Halal & Nunes, 2014; Dinis & Bragança, 2018; İşsever et al., 2021) will be given by the researcher. A Sleep Hygiene Training Booklet will be prepared for use in education and to give to adolescents after education.The Sleep Hygiene training booklet to be prepared will be prepared by the researcher and submitted for expert opinions. Adolescents who received sleep hygiene training will be reapply 15 days after the training, with the PedsQL and AIQ.

    No attempt will be made to the adolescents who will be in the control group, and the Introductory Characteristics Form for Adolescents, the Pediatric Quality of Life Inventory (PedsQL) and Adolescent Insomnia Questionary (AIQ) will be applied on the same dates in parallel with the education and music application groups.

    Outcomes

    Primary Outcome Measures

    Adolescent Insomnia Questionnaire
    Scores from the scale range from 0 to 52, and the higher the score, the higher the insomnia. The cut-off point of the scale was accepted as 15 points and above.
    Adolescent Insomnia Questionnaire
    Scores from the scale range from 0 to 52, and the higher the score, the higher the insomnia. The cut-off point of the scale was accepted as 15 points and above.
    Quality of Life Scale for Adolescent Form
    . Scale items are scored between 25 and 100. The total score obtained from the scale is obtained by taking the arithmetic average of the scores obtained from the scale. The higher the total score obtained from the scale, the higher the health-related quality of life
    Quality of Life Scale for Adolescent Form
    . Scale items are scored between 25 and 100. The total score obtained from the scale is obtained by taking the arithmetic average of the scores obtained from the scale. The higher the total score obtained from the scale, the higher the health-related quality of life

    Secondary Outcome Measures

    Full Information

    First Posted
    December 9, 2022
    Last Updated
    February 14, 2023
    Sponsor
    TC Erciyes University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05665842
    Brief Title
    The Effects of Education and Music Practice on Insomnia and Quality of Life
    Official Title
    Effects of Sleep Hygiene Education and Music Practice on Insomnia and Quality of Life in Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 19, 2023 (Anticipated)
    Primary Completion Date
    March 19, 2023 (Anticipated)
    Study Completion Date
    December 19, 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Background: Insomnia is the most common problem among sleep disorders. Approximately 4-39% of the general adolescent population appears to experience clinically classified insomnia. Insomnia in adolescence, when intellectual, physiological, psychological and social changes are intense, deprives adolescents of the attention and cognition needed to play an active role in these exciting and challenging processes. The aim of this study was to evaluate the effect of music practice and sleep hygiene education in adolescents aged 14-18 years with insomnia. Method: The study will conduct in a randomized controlled experimental design with three groups. The population of the study consists of adolescents aged 14-18, who are studying in Amasya City Center. The sample of the study will be 60 adolescents in the sleep hygiene education group (20), the music practice group (20) and the control group (20). The research will be carried out between September and November 2022.In this study, data will with collect Descriptive Characteristics Form for Adolescents and Their Families, Adolescent Insomnia Questionnaire and Quality of Life Scale for Children.
    Detailed Description
    The type of Research It will be conducted as a randomized controlled experimental study in a pre-test-post-test design to determine the effect of sleep hygiene education and music practice on insomnia and quality of life in 14-18 age group adolescents. Location and Characteristics of the study Research The second phase of this study, which examines the effects of sleep hygiene education and music practice on sleeplessness and quality of life in adolescents, will be conducted with adolescents aged 14-18 who are studying in high schools in the city center of Amasya Provincial Directorate of National Education in the 2022-2023 academic year. Population and Sample of the Research The universe of the research is high school 9-12 in the city center affiliated to the Amasya Provincial Directorate of National Education in the 2022-2023 academic year. It will consist of adolescents aged 14-18 who attend their classes. The sample number of this study will be determined with the sample calculation of the known universe. In high schools selected using the random numbers table, students with ALS scores of 15 and above (with high insomnia scores) will be determined by applying ALS to as many students as the calculated sample number. Adolescents who will be included in the experimental research part of the second phase of this study will be selected by a simple random method from students who have high insomnia scores and meet the research criteria. For this purpose, the computer program (randomizer.org) will be used. In the literature review, no similar studies were found for the subject and age group of this study. However, according to the findings of studies on sleep quality in adolescents (Çağlar, 2020) and the power analysis performed in GPower (effect size = 0.97, impact power = 0.90) the sample size varies between 57 adolescents. In this study, it was decided to have 20 samples in each group according to α=95% confidence level and 90% power. After reaching 20 adolescents in each group, power analysis will be calculated using insomnia scores and it will be decided whether the sample size is sufficient or not. Although the number of students in high schools on the dates of the second phase of the study is not known at the moment, 8464 students in the 14-18 age group continue their education in 21 high schools in the 2021-2022 academic year. Application In this study, which examines the effects of sleep hygiene education and music practice on insomnia and quality of life of 14-18-year-old adolescents, intervention and control groups will be studied in a pre-test and post-test design. No intervention will be applied to the control group. To the initiative groups; it was planned to apply music to the students in the 1st group, and sleep hygiene training to the students in the 2nd group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (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 the adolescents in the music practice group, the Introductory Characteristics Form for Adolescents, PedsQL and AIQ will be applied. After, the predetermined instrumental music will be shared with the adolescents every evening for 15 days via social media by the researcher and participants will be asked to listen to these music. Participants will listen to the instrumental music sent by the researcher for at least 20 minutes every evening during the music application. This whole process will be reminded to the adolescents with messages every evening and they will be asked to listen the music before the normal bedtime (before 23:00 at night). At the end of the music application (after 15 days), the Introductory Characteristics Form for Adolescents, PedsQL and AIQ will be reapplied.
    Arm Title
    Sleep Hygiene Training Group
    Arm Type
    Experimental
    Arm Description
    After explaining the purpose of the study and the way it was applied to the adolescents in the music practice group, the Introductory Characteristics Form for Adolescents, the Pediatric Quality of Life Inventory (PedsQL) and Adolescent Insomnia Questionary (AIQ) will be applied. Adolescents in this group will be trained on Zoom for 4 weeks, 2 times a week, for 8 sessions (1 session 40 min). Sleep hygiene training prepared based on expert opinions and literature (Halal & Nunes, 2014; Dinis & Bragança, 2018; İşsever et al., 2021) will be given by the researcher. A Sleep Hygiene Training Booklet will be prepared for use in education and to give to adolescents after education.The Sleep Hygiene training booklet to be prepared will be prepared by the researcher and submitted for expert opinions. Adolescents who received sleep hygiene training will be reapply 15 days after the training, with the PedsQL and AIQ.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    No attempt will be made to the adolescents who will be in the control group, and the Introductory Characteristics Form for Adolescents, the Pediatric Quality of Life Inventory (PedsQL) and Adolescent Insomnia Questionary (AIQ) will be applied on the same dates in parallel with the education and music application groups.
    Intervention Type
    Other
    Intervention Name(s)
    Music Application
    Intervention Description
    The Introductory Characteristics Form for Adolescents, the PedsQL and AIQ will be applied. After, the predetermined instrumental music will be shared with the adolescents every evening for 15 days via social media by the researcher and participants will be asked to listen to these music. Participants will listen to the instrumental music sent by the researcher for at least 20 minutes every evening during the music application. This whole process will be reminded to the adolescents with messages every evening and they will be asked to listen the music before the normal bedtime (before 23:00 at night). At the end of the music application (after 15 days), the Introductory Characteristics Form for Adolescents, the PedsQL and AIQ will be reapplied. In the music application, the selecting instrumental music will be used. To determine the music, the researcher will be advice received from the TÜMATA and the a music education expert.
    Intervention Type
    Other
    Intervention Name(s)
    Sleep Hygiene Training
    Intervention Description
    After explaining the purpose of the study and the way it was applied to the adolescents in the music practice group, the Introductory Characteristics Form for Adolescents, the Pediatric Quality of Life Inventory (PedsQL) and Adolescent Insomnia Questionary (AIQ) will be applied. Adolescents in this group will be trained on Zoom for 4 weeks, 2 times a week, for 8 sessions (1 session 40 min). Sleep hygiene training prepared based on expert opinions and literature (Halal & Nunes, 2014; Dinis & Bragança, 2018; İşsever et al., 2021) will be given by the researcher. A Sleep Hygiene Training Booklet will be prepared for use in education and to give to adolescents after education.The Sleep Hygiene training booklet to be prepared will be prepared by the researcher and submitted for expert opinions. Adolescents who received sleep hygiene training will be reapply 15 days after the training, with the PedsQL and AIQ.
    Primary Outcome Measure Information:
    Title
    Adolescent Insomnia Questionnaire
    Description
    Scores from the scale range from 0 to 52, and the higher the score, the higher the insomnia. The cut-off point of the scale was accepted as 15 points and above.
    Time Frame
    a day before the music application and sleep hygiene education
    Title
    Adolescent Insomnia Questionnaire
    Description
    Scores from the scale range from 0 to 52, and the higher the score, the higher the insomnia. The cut-off point of the scale was accepted as 15 points and above.
    Time Frame
    through application and education completion, an average of 1 months
    Title
    Quality of Life Scale for Adolescent Form
    Description
    . Scale items are scored between 25 and 100. The total score obtained from the scale is obtained by taking the arithmetic average of the scores obtained from the scale. The higher the total score obtained from the scale, the higher the health-related quality of life
    Time Frame
    a day before the music application and sleep hygiene education
    Title
    Quality of Life Scale for Adolescent Form
    Description
    . Scale items are scored between 25 and 100. The total score obtained from the scale is obtained by taking the arithmetic average of the scores obtained from the scale. The higher the total score obtained from the scale, the higher the health-related quality of life
    Time Frame
    through application and education completion, an average of 1 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Those between the ages of 14-18, Receiving 15 points or more in AOS, Having no vision, hearing, or speech problems, Able to speak and write Turkish, No mental or neurological disability, Participating in the training program with the zoom program, Smartphone, using social media communication (WhatsApp), It was planned to include the adolescents who had the permission of themselves and their parents to participate in the study in the second phase of the study. Exclusion Criteria: Adolescents who want to withdraw from the study at any stage of the study will be excluded from the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pınar TEKCAN, PhD-c
    Phone
    +90505 388 3710
    Email
    pinar.tekcan@amasya.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emine Erdem, Professor
    Phone
    +90532 606 6277

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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