Clinical trial NCT05665842: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Adolescent Insomnia Questionnaire
timeFrame: a day before the music application and sleep hygiene education
measure: Adolescent Insomnia Questionnaire
timeFrame: through application and education completion, an average of 1 months
measure: Quality of Life Scale for Adolescent Form
timeFrame: a day before the music application and sleep hygiene education
measure: Quality of Life Scale for Adolescent Form
timeFrame: through application and education completion, an average of 1 months
Secondary outcomes:
Other outcomes:
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Study officials:
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