The Effects of Education and Music Practice on Insomnia and Quality of Life
NCT ID: NCT05665842
Last Updated: 2023-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-02-19
2023-12-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Music on Sleep Quality and Comfort in Elderly: a Randomized Controlled Trial
NCT06843941
Music Interventions for the Facilitation of Sleep in the Acute Geriatric Setting
NCT05398419
Effectiveness of Music Therapy on Sleep Disorders
NCT04578860
Survey of Students' Sleep Related Outcomes and Sleep Management Network for Sleep
NCT03627221
Music for Insomnia
NCT02321826
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Music Application Group
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.
Music Application
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.
Sleep Hygiene Training Group
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.
Sleep Hygiene Training
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.
Control Group
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Music Application
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.
Sleep Hygiene Training
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
14 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TC Erciyes University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pınar Tekcan
Principal Investigator
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Emine Erdem, Professor
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ErciyesU.PTekcan1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.