Adolescent BehaviorNCT05071989
The Influence of Sleep Education With Social Media Reminders on the Sleep Quality in Adolescents
A study testing Sleep Education in people with Adolescent Behavior, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior
- What is being tested?
- Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2019to 15 Jun 2020
- 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
- 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
Who cannot join
- Use sleeping pills
- Have psychiatric and chronic diseases
- Have mental disabilities were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University
Bolu, 14030
About this study
Official title: The Influence of Sleep Education Supported and Unsupported With Social Media Reminders on the Sleep Quality in Adolescents Aged 14-18: Randomized Controlled Study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Adolescent Behavior
- Being tested
- Sleep Education
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep EducationBehavioural
A single-blind school- based randomized controlled design
| Study group | Role | What they receive |
|---|---|---|
| Sleep education group do not supported with social media reminders | Experimental | Sleep education do not supported with social media reminders Receives: Behavioral: Sleep Education |
| Sleep education group supported with social media reminders | Experimental | Sleep education group supported with social media reminders Receives: Behavioral: Sleep Education |
| Control group | No intervention | No intervention was made in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start9 Sep 2019
- Primary completion6 Jan 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Songül Çağlar, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071989
- Sponsor's protocol ID
- BAIBU-SBF-SC-01
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39320594
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Sleep Education Supported and Unsupported With Social Media Reminders on the Sleep Quality in Adolescents Aged 14-18: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05071989
- Acronym / sponsor ID
- BAIBU-SBF-SC-01
- Conditions
- Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 8 Oct 2021 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleep education group do not supported with social media reminders | Experimental | Behavioral: Sleep EducationSleep education do not supported with social media reminders |
| Sleep education group supported with social media reminders | Experimental | Behavioral: Sleep EducationSleep education group supported with social media reminders |
| Control group | No intervention | –No intervention was made in the control group. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Use sleeping pills
- Have psychiatric and chronic diseases
- Have mental disabilities were 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 |
|---|---|---|
| Sleep EducationA single-blind school- based randomized controlled design | Behavioural | Sleep education group do not supported with social media reminders, Sleep education group supported with social media reminders |
Primary outcome
Sleep Quality
Time frame: 4 weeks
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.
Sleepiness
Time frame: 4 weeks
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.
Sleep hygiene
Time frame: 4 weeks
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).
Sleep parameters
Time frame: 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 39320594Caglar 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.
- Individual participant dataSharing planned: No
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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.
Songül Çağlar, PhD principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Education in people with Adolescent Behavior, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT05071989, which also lists 1 linked publication.
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 8 Oct 2021.