High School 11th Grade StudentsNCT06004778
The Effect of Motivational Support Program Applied to Adolescents on Sleep Quality and Academic Achievement
A study testing Motivational Support Program and Educational support in people with High School 11th Grade Students and Absence of Any Language, Hearing, Mental or Psychological Disability, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
It was planned as a randomized controlled experimental study with a single-blind technique, pretest-posttest control group and repetitive measurements, in order to determine the effect of motivational support program applied to adolescents and education on sleep quality. Read more about this study
- Who is it for?
- Ages 16 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- High School 11th Grade Students, Absence of Any Language, Hearing, Mental or Psychological Disability, Turkish Speaking and Understanding
- What is being tested?
- Motivational Support Program and Educational support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Sep 2023to 19 Jan 2024
- 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 16 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- No language disorders
- No hearing disorders
- No mental disorders
- Bad sleep quality
- No chronic disease
Who cannot join
- Sleeping pill
- Psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lecturer (Academician at University)
It was planned as a randomized controlled experimental study with a single-blind technique, pretest-posttest control group and repetitive measurements, in order to determine the effect of motivational support program applied to adolescents and education on sleep quality.
- Conditions
- High School 11th Grade Students, Absence of Any Language, Hearing, Mental or Psychological Disability, Turkish Speaking and Understanding, Having a PUKI Index Above 5ı, Absence of Any Chronic Disease, Obtaining Permission From Parents and Students
- Being tested
- Motivational Support Program, Educational support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Support ProgramBehavioural
In studies conducted on adolescents with poor sleep quality, no study using motivational interviewing technique was found.
Educational supportBehavioural
educational support
| Study group | Role | What they receive |
|---|---|---|
| Motivational Support Program | Experimental | Training booklet will be provided.A total of 5 sessions of sleep training will be given by dividing them into groups of 30 minutes, 3 days a week for 2 weeks.Individual motivational interviews will be held with students and reminder messages will be sent twice a week. Receives: Behavioral: Motivational Support Program |
| educational support | Active comparator | Training booklet will be provided. A total of 5 sessions of sleep training will be given by dividing them into groups of 30 minutes, 3 days a week for 2 weeks. Receives: Behavioral: Educational support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality Score
Adolescents receiving motivational support programs have higher average sleep quality scores.
Measured: up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)
Secondary outcomes (1)
Academic Achievement Score
Adolescents receiving motivational support program had higher academic achievement averages.
Measured: up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start13 Sep 2023 (estimated)
- Primary completion19 Jan 2024 (estimated)
- Study completion19 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High School 11th Grade StudentsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Sokun Ayaz, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004778
- Sponsor's protocol ID
- Demet Sokun Ayaz
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lecturer (Academician at University)
- ClinicalTrials.gov ID
- NCT06004778
- Acronym / sponsor ID
- Demet Sokun Ayaz
- Conditions
- High School 11th Grade Students, Absence of Any Language, Hearing, Mental or Psychological Disability, Turkish Speaking and Understanding, Having a PUKI Index Above 5ı, Absence of Any Chronic Disease, Obtaining Permission From Parents and Students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 13 Sep 2023 (estimated)
- Primary completion
- 19 Jan 2024 (estimated)
- Study completion
- 19 Jan 2024 (estimated)
- First posted
- 22 Aug 2023 (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.
It was planned as a randomized controlled experimental study with a single-blind technique, pretest-posttest control group and repetitive measurements, in order to determine the effect of motivational support program applied to adolescents and education on sleep quality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Support Program | Experimental | Behavioral: Motivational Support ProgramTraining booklet will be provided.A total of 5 sessions of sleep training will be given by dividing them into groups of 30 minutes, 3 days a week for 2 weeks.Individual motivational interviews will be held with students and reminder messages will be sent twice a week. |
| educational support | Active comparator | Behavioral: Educational supportTraining booklet will be provided. A total of 5 sessions of sleep training will be given by dividing them into groups of 30 minutes, 3 days a week for 2 weeks. |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- No language disorders
- No hearing disorders
- No mental disorders
- Bad sleep quality
- No chronic disease
Key exclusion criteria (2 listed)
- Sleeping pill
- Psychiatric illness
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 |
|---|---|---|
| Motivational Support ProgramIn studies conducted on adolescents with poor sleep quality, no study using motivational interviewing technique was found. | Behavioural | Motivational Support Program |
| Educational supporteducational support | Behavioural | educational support |
Primary outcome
Sleep quality Score
Time frame: up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)
Adolescents receiving motivational support programs have higher average sleep quality scores.
1 secondary outcome
Academic Achievement Score
Time frame: up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Support Program and Educational support in people with High School 11th Grade Students and Absence of Any Language, Hearing, Mental or Psychological Disability, run by Istanbul University - Cerrahpasa 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 2 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 22 Aug 2023. 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?
Results are not available in the source record.
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 Score (time frame: up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)). 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 22 Aug 2023.