MindfulnessNCT05994911
Mindfulness Education in Adolescents
A study testing Mindfulness Training in people with Mindfulness, run by Ejdane Coskun at 1 site in Turkey (Türkiye).
Trial summary
Aim: It was planned to evaluate the impact of mindfulness training on interpersonal style and perceived social competence in adolescents. Read more about this study
- Who is it for?
- Ages 17 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness
- What is being tested?
- Mindfulness Training
- 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
- 30 Oct 2023to 25 Dec 2023
- 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 17 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- be a high school student
Who cannot join
- Having any psychiatric illness that prevents adequate communication will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Türkiye
Osmaniye, Korkut Ata University, 80000
About this study
Official title: The Effect of Mindfulness Education on Interpersonal Style and Perceived Social Competence in Adolescents
Aim: It was planned to evaluate the impact of mindfulness training on interpersonal style and perceived social competence in adolescents.
Read the detailed description
In the research, high school students will form the universe according to the education in the relevant institution. Based on a study with a similar design, it was decided to include 60 people, 30 in the intervention group and 30 in the control group, according to the effect size.
- Conditions
- Mindfulness
- Being tested
- Mindfulness Training
- Keywords
- Mindfulness Training, Adolescent, Interpersonal Style, Perceived Social Competence, Psychiatric nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
Also called Mindfulness
The application is planned as 8 sessions and one session per week. Each session corresponds to one lesson hour and is approximately 30-40 minutes. In the content of the application, the individual's attention, mind, attitude, intention, thought; It has basic concepts such as the separation and merging process of thoughts in our minds, the deep processes of awareness, staying in the moment, values, focusing process, self-compassion, integration of awareness with other situations in life, meditation practices developed with practice, and the content summarized around these concepts. It is a program that tries to enable individuals to focus on the moment they live in, within the framework of these basic concepts. The program is divided into session titles such as "Introduction to Mindfulness", "Mind Awareness", "Body Awareness", "Emotion and Behavior Awareness", "Self Compassion", "Stress Awareness", "Eating Awareness".
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training adolescent | Experimental | An 8-week interview will be conducted with the individuals in the experimental group in the research in which the mindfulness training psychiatric nursing approach is applied. The control group will continue their routine school life. Individuals in the experimental group will be trained as a group and initiatives will be implemented in line with the goals of the individuals and the objectives of the research. Receives: Behavioral: Mindfulness Training |
| Mindfulness | No intervention | Individuals in the control group will continue their school life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness training affects interpersonal style in adolescents.
It was developed to determine what style they use in interpersonal relationships. It is a self-assessment scale consisting of sixty items. The items are answered according to the question "How much does it describe you" and are answered in a 5-point Likert type as 0%, 25%, 50%, 75% and 100%. 0.1%, 1 point; 25%, 2 points; 50%, 3 points; 75% are evaluated with 4 points and 100% with 5 points. Accordingly, a minimum of 60 and a maximum of 300 points can be obtained.
Measured: up to 8 weeks
Secondary outcomes (1)
Mindfulness training affects perceived social competence in adolescents
The Perceived Social Competence Scale is a one-dimensional scale consisting of 6 items and items. The highest score that can be obtained from the scale is 30, and the lowest score is 6. It can be said that as the scores obtained from the Perceived Social Competence Scale, which does not have any reversed items, increase, the perceived social competency level of the individual also increases
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start30 Oct 2023
- Primary completion25 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ejdane Coskun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ejdane Coskun, Osmaniye Korkut Ata University
- Investigators
- Ejdane Coşkun, Lect., Principal investigator, Korkut Ata University Osmaniye, Center, Türkiye, 80000Ayşe İNEL MANAV, Assoc. Prof, Principal investigator, Korkut Ata University Osmaniye, Center, Türkiye, 80000Hüsne Demirel, Assoc. Prof, Principal investigator, Gazi University Ankara, Center, Türkiye, 06500Yunus Ömer Arık, Grad. stud., Principal investigator, Korkut Ata University Osmaniye, Center, Türkiye, 80000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994911
- Sponsor's protocol ID
- Mindfulness
- Status last verified
- Jan 2024
- First submitted
- 8 Aug 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Education on Interpersonal Style and Perceived Social Competence in Adolescents
- ClinicalTrials.gov ID
- NCT05994911
- Acronym / sponsor ID
- Mindfulness
- Conditions
- Mindfulness
- Keywords
- Mindfulness Training, Adolescent, Interpersonal Style, Perceived Social Competence, Psychiatric nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ejdane CoskunUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 16 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.
Aim: It was planned to evaluate the impact of mindfulness training on interpersonal style and perceived social competence in adolescents.
Detailed description
In the research, high school students will form the universe according to the education in the relevant institution. Based on a study with a similar design, it was decided to include 60 people, 30 in the intervention group and 30 in the control group, according to the effect size.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training adolescent | Experimental | Behavioral: Mindfulness TrainingAn 8-week interview will be conducted with the individuals in the experimental group in the research in which the mindfulness training psychiatric nursing approach is applied. The control group will continue their routine school life. Individuals in the experimental group will be trained as a group and initiatives will be implemented in line with the goals of the individuals and the objectives of the research. |
| Mindfulness | No intervention | –Individuals in the control group will continue their school life. |
Who may qualify
- Ages
- 17 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- be a high school student
Key exclusion criteria (1 listed)
- Having any psychiatric illness that prevents adequate communication will not be included in 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 |
|---|---|---|
| Mindfulness TrainingAlso: MindfulnessThe application is planned as 8 sessions and one session per week. Each session corresponds to one lesson hour and is approximately 30-40 minutes. In the content of the application, the individual's attention, mind, attitude, intention, thought; It has basic concepts such as the separation and merging process of thoughts in our minds, the deep processes of awareness, staying in the moment, values, focusing process, self-compassion, integration of awareness with other situations in life, meditation practices developed with practice, and the content summarized around these concepts. It is a program that tries to enable individuals to focus on the moment they live in, within the framework of these basic concepts. The program is divided into session titles such as "Introduction to Mindfulness", "Mind Awareness", "Body Awareness", "Emotion and Behavior Awareness", "Self Compassion", "Stress Awareness", "Eating Awareness". | Behavioural | Mindfulness Training adolescent |
Primary outcome
Mindfulness training affects interpersonal style in adolescents.
Time frame: up to 8 weeks
It was developed to determine what style they use in interpersonal relationships. It is a self-assessment scale consisting of sixty items. The items are answered according to the question "How much does it describe you" and are answered in a 5-point Likert type as 0%, 25%, 50%, 75% and 100%. 0.1%, 1 point; 25%, 2 points; 50%, 3 points; 75% are evaluated with 4 points and 100% with 5 points. Accordingly, a minimum of 60 and a maximum of 300 points can be obtained.
1 secondary outcome
Mindfulness training affects perceived social competence in adolescents
Time frame: up to 8 weeks
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 23 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Mindfulness
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App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
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The Mindful Smartphone Use Study
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Meditation for Older Adults With Chronic Low Back Pain
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The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
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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.
Ejdane Coşkun, Lect. principal investigator
Korkut Ata University Osmaniye, Center, Türkiye, 80000
Ayşe İNEL MANAV, Assoc. Prof principal investigator
Korkut Ata University Osmaniye, Center, Türkiye, 80000
Hüsne Demirel, Assoc. Prof principal investigator
Gazi University Ankara, Center, Türkiye, 06500
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training in people with Mindfulness, run by Ejdane Coskun 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 1 inclusion and 1 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 23 Jan 2024. 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?
Mindfulness training affects interpersonal style in adolescents. (time frame: up to 8 weeks). 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 23 Jan 2024.