Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders

NCT number NCT05665842
Study type Interventional
Source TC Erciyes University
Contact Pinar TEKCAN, PhD-c
Phone +90505 388 3710
Email pinar.tekcan@amasya.edu.tr
Status Not yet recruiting
Phase N/A
Start date February 19, 2023
Completion date December 19, 2023

See also
  Status Clinical Trial Phase
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT05963542 - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia N/A
Completed NCT06339853 - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia N/A
Recruiting NCT04069247 - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia N/A
Completed NCT04493593 - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Recruiting NCT06278077 - Neurexan - a Clinical Trial in Short-Term Insomnia Patients Phase 2
Completed NCT04661306 - The Better Sleep for Supporters With Insomnia Study N/A
Recruiting NCT06207279 - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting NCT06006299 - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC) N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04035200 - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation Phase 2
Active, not recruiting NCT05027438 - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention N/A
Recruiting NCT06053840 - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia Phase 4
Not yet recruiting NCT06348082 - Project Women's Insomnia Sleep Health Equity Study (WISHES) N/A
Not yet recruiting NCT06363799 - Osteopathic Protocol for Insomnia in College Students N/A
Not yet recruiting NCT06025968 - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis N/A
Not yet recruiting NCT05991492 - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application N/A