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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05071989
Other study ID # BAIBU-SBF-SC-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 9, 2019
Est. completion date June 15, 2020

Study information

Verified date September 2021
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The application of the research was planned according to the literature review and recommendations of the cognitive behavioral therapy approach. Sleep-related CBT practices consist of stimulus control, sleep restriction, relaxation techniques, managing sleep-related concerns, sleep hygiene education, and paradoxical intention. CBT practices consist of stimulus control and sleep hygiene education were used in this study. The sleep hygiene education that is part of the CBT method was used in the sleep education given to the Experiment 1 group. The sleep hygiene education that is part of the CBT method and the written stimulus control applications with WhatsApp was performed twice a day in the Experiment 2 group.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 15, 2020
Est. primary completion date January 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Use sleeping pills - Have psychiatric and chronic diseases - Have mental disabilities were excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep Education
A single-blind school- based randomized controlled design

Locations

Country Name City State
Turkey Bolu Abant Izzet Baysal University Bolu

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Agargün 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
Primary 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 Çaglar and Tokur Kesgin. 4 weeks
Primary 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
Primary 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
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