NCT05071989

Brief Summary

Objective: This study aimed to determine the effect of sleep education, supported and unsupported with social media reminders, on sleep quality in 14-18 age group adolescents. Design: This study is in a single-blind randomized controlled design. The study was carried out between October 2019 and January 2020. Participants: The sample of this study consisted of 60 students randomly selected from three Anatolian High Schools in the city center. The students were divided into 3 groups of 20 people each (Experiment 1, Experiment 2, and Control). According to the scan result, adolescents who have sleep quality (PSQI\>5 and CASQ\>16), use Smartphone and the internet, have no chronic diseases and obesity, and have no mental problems were included in the study. Adolescents who use sleeping pills or any other medication and have communication obstacles were excluded from the study. The study was completed with 55 adolescents due to the separation of 5 adolescents during the experiment. Intervention: The sleep education group, which was unsupported with social media reminders, was given sleep education for 30 minutes once a week for four weeks at school. In addition to the education at school, information messages and warnings were sent to the sleep education group, which was supported with social media reminders, via WhatsApp. The control group did not receive any intervention other than taking measurements of sleep parameters once a week. Main Outcome(s) and Measure(s): The data were collected with Pittsburgh Sleep Quality Index, Cleveland Adolescent Sleepiness Questionnaire, Adolescent Sleep Habits Form and MI Band 3 device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

September 15, 2021

Last Update Submit

September 28, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Sleep Quality

    Pittsburgh Sleep Quality Index (PSQI):It is the most widely used scale to measure subjective sleep quality in the international literature. The scale was developed by Buyyse et al., in 1989, and validity and reliability studies in Turkish were carried out by Ağargün et al. The index has a diagnostic sensitivity of 89.6% and a specificity of 86.5%. The scale consists of a total of 18 items that make up 7 components. The maximum score that can be taken from the scale is 21. A score above 5 indicates poor sleep quality, while below 5 indicates good sleep quality.

    4 weeks

  • Sleepiness

    Cleveland Adolescent Sleepiness Questionnaire (CASQ): This scale provides a valid and reliable subjective measure that was used to determine the daytime sleepiness of adolescents aged 11-17 years. The scale was developed by Spilsbury et al., consists of 16 item questions measuring daytime sleepiness in adolescents. Scores range from 16 to 80 on a 5-point Likert-type scale (never: 1; rarely: 2; sometimes: 3; usually: 4; almost everyday: 5). Five of the statements are scored in the opposite direction. Daytime sleepiness is obtained by summing the scores of 16 items and the higher the score, the higher the daytime sleepiness. The high internal consistency of the scale (Cronbach's Alpha= 0.89) can be used both in clinical (for instance, in those with obstructive sleep apnea or OSA) and clinically healthy normal adolescents. The Turkish validity-reliability study of the scale was carried out in 2020 by Çağlar and Tokur Kesgin.

    4 weeks

  • Sleep hygiene

    Adolescent Sleep Habits Form (ASHF): According to the information obtained through the literature review, ASHF for sleep hygiene consisting of 33 questions for the adolescent age group was created. Opposite each question, some answers include "Never (0), rarely (1), Sometimes (2), Often (3) and Always (4)". The minimum score that can be taken from the questionnaire is 0, and the maximum is 132. It is conceivable that the higher the questionnaire score, the better the adolescent performs sleep hygiene practices. Davis' technique was used for the content validity of the questionnaire. To evaluate the survey questions in terms of scope, the opinions of 5 experts were consulted ( one of them is an assessment and evaluation specialist in education, four of them are faculty members from the field of nursing).

    4 weeks

  • Sleep parameters

    Xiaomi Mi Band 3 Sleeping Wristband: In the study, the sleep parameters of the students were followed by the Xiaomi Mi Band 3 actigraph wristband. Previous studies have proven that a wristband is a reliable device for measuring sleep parameters. This wristband was used as an actigraph for reasons such as a charging time of about two weeks, being waterproof, being compatible with Android devices and not requiring separate software for transferring data to a computer. The data on sleep parameters (total sleep time, deep and light sleep levels, time of falling asleep and waking up, time of sleep interruption) obtained in the study were recorded by the researcher every week from the students.

    4 weeks

Study Arms (3)

Sleep education group do not supported with social media reminders

EXPERIMENTAL

Sleep education do not supported with social media reminders

Behavioral: Sleep Education

Sleep education group supported with social media reminders

EXPERIMENTAL

Sleep education group supported with social media reminders

Behavioral: Sleep Education

Control group

NO INTERVENTION

No intervention was made in the control group.

Interventions

Sleep EducationBEHAVIORAL

A single-blind school- based randomized controlled design

Sleep education group do not supported with social media remindersSleep education group supported with social media reminders

Eligibility Criteria

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

You may qualify if:

  • Don't have any language and hearing problems
  • Use the internet and Smartphone
  • Do not have any chronic diseases
  • Mental disorders and obesity
  • Do not use any medication that causes sleep problems

You may not qualify if:

  • Use sleeping pills
  • Have psychiatric and chronic diseases
  • Have mental disabilities were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University

Bolu, 14030, Turkey (Türkiye)

Location

Related Publications (1)

  • Caglar S, Kesgin MT. The influence of sleep education supported and unsupported with social media reminders on the sleep quality in adolescents aged 14-18: a three-center, parallel-arm, randomized controlled study. Sleep Breath. 2024 Dec;28(6):2581-2590. doi: 10.1007/s11325-024-03138-6. Epub 2024 Sep 25.

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Songül Çağlar, PhD

    Bolu Abant İzzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 8, 2021

Study Start

September 9, 2019

Primary Completion

January 6, 2020

Study Completion

June 15, 2020

Last Updated

October 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations