NCT05665842

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 19, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

28 days

First QC Date

December 9, 2022

Last Update Submit

February 14, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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

    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

    through application and education completion, an average of 1 months

Study Arms (3)

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.

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.

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.

Interventions

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.

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, 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 Group

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Adolescents who want to withdraw from the study at any stage of the study will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Emine Erdem, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 27, 2022

Study Start

February 19, 2023

Primary Completion

March 19, 2023

Study Completion

December 19, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02