InsomniaNCT05665842
The Effects of Education and Music Practice on Insomnia and Quality of Life
A study testing Music Application and Sleep Hygiene Training in people with Insomnia, run by TC Erciyes University.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Music Application and Sleep Hygiene Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 19 Feb 2023to 19 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Adolescents who want to withdraw from the study at any stage of the study will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
Emine Erdem, Professor contact
About this study
Official title: Effects of Sleep Hygiene Education and Music Practice on Insomnia and Quality of Life in Adolescents
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Music Application, Sleep Hygiene Training
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ApplicationOther
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 TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Application Group | Experimental | 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. Receives: Other: Music Application |
| Sleep Hygiene Training Group | Experimental | 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. Receives: Other: Sleep Hygiene Training |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: a day before the music application and sleep hygiene education
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.
Measured: through application and education completion, an average of 1 months
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
Measured: a day before the music application and sleep hygiene education
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
Measured: through application and education completion, an average of 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start19 Feb 2023 (estimated)
- Primary completion19 Mar 2023 (estimated)
- Study completion19 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Tekcan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665842
- Sponsor's protocol ID
- ErciyesU.PTekcan1
- Status last verified
- Feb 2023
- First submitted
- 9 Dec 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Hygiene Education and Music Practice on Insomnia and Quality of Life in Adolescents
- ClinicalTrials.gov ID
- NCT05665842
- Acronym / sponsor ID
- ErciyesU.PTekcan1
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 19 Feb 2023 (estimated)
- Primary completion
- 19 Mar 2023 (estimated)
- Study completion
- 19 Dec 2023 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music Application Group | Experimental | Other: Music ApplicationAfter 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. |
| Sleep Hygiene Training Group | Experimental | Other: Sleep Hygiene TrainingAfter 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 intervention | –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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (1 listed)
- Adolescents who want to withdraw from the study at any stage of the study will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music ApplicationThe 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. | Other | Music Application Group |
| Sleep Hygiene TrainingAfter 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. | Other | Sleep Hygiene Training Group |
Primary outcome
Adolescent Insomnia Questionnaire
Time frame: a day before the music application and sleep hygiene education
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
Time frame: through application and education completion, an average of 1 months
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
Time frame: a day before the music application and sleep hygiene education
. 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
Time frame: through application and education completion, an average of 1 months
. 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine Erdem, Professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Music Application and Sleep Hygiene Training in people with Insomnia, run by TC Erciyes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pınar TEKCAN, PhD-c (+90505 388 3710, pinar.tekcan@amasya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Insomnia Questionnaire (time frame: a day before the music application and sleep hygiene education). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.