Adolescent BehaviorNCT05324709
Yoga on Stress Management in Adolescents
A study testing Yoga Based Stress Management Program in people with Adolescent Behavior and Adolescent Problem Behavior, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
The World Health Organization (WHO, 2013) defined the 10-19 age group as "adolescent" and the 15-24 age group as "youth". Adolescence period; It is a period of rapid growth, development and maturation in terms of physical, mental, biochemical and social aspects.10-20% of children and adolescents living in the world… Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Adolescent Problem Behavior
- What is being tested?
- Yoga Based Stress Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2022to 18 Aug 2022
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school senior student
- Those who volunteered to participate in the research and
- Students who are allowed to participate in the research by their parents
Who cannot join
- Students with any physical or mental disability • Low levels of perceived stress, anxiety, depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yoga on Stress Management in Adolescents: Randomized Controlled Trial
The World Health Organization (WHO, 2013) defined the 10-19 age group as "adolescent" and the 15-24 age group as "youth". Adolescence period; It is a period of rapid growth, development and maturation in terms of physical, mental, biochemical and social aspects.10-20% of children and adolescents living in the world have mental health diseases such as generalized anxiety disorders, depression, eating disorders, and post-traumatic stress disorders.In adolescents, yoga is practiced as a relaxing tool to reduce stress, especially for exam anxiety.In Turkey, there are no yoga-based experimental studies to prevent anxiety, stress and depression in adolescents.
Read the detailed description
The aim of the study is to examine the effect of the Yoga-Based Stress Management Program on the ability to cope with stress in adolescents.Stress management sessions of the Adolescent Health Promotion-Physical Activity, Nutrition, Stress Management (COPE HEALTH-TEEN) program will be used in the stress management training to be explained in the program. There will also be yin yoga exercises.
The general population of the research will be high school senior students in Safranbolu district of Karabük province in the 2021-2022 academic year. First of all, the stress, anxiety and depression levels of the adolescents will be calculated. The research will be carried out in a total of 14 high schools. Each school will be determined as a "cluster" and 7 experimental and 7 control schools will be randomly selected. Simple random draw method will be applied in the selection of experimental and control schools. Adolescents who meet the inclusion criteria will be included in the study.
- Conditions
- Adolescent Behavior, Adolescent Problem Behavior
- Being tested
- Yoga Based Stress Management Program
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga Based Stress Management ProgramBehavioural
Yoga-based stress management program is applied to the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The program will be carried out one day a week for four weeks. Yin yoga practices will be applied in the program. Each session will last a total of 40 minutes. The first 20 minutes of yin yoga sessions. Participants will be given training on stress management, breathing and yin yoga. Afterwards, each session of Yin yoga exercises will be started with pranayama (breathing) exercises for 2 minutes, followed by Suryanamaskar-A (Sun Salute-A) for warming up and Yin yoga exercises will be done. The program will be completed by applying the focus on Moment in the last 5 minute. In addition, the participants will be given homework related to the subject of each week. The training booklet will be distributed to the participants before the program. Stress management sessions of the Adolescent Health Promotion-Physical Activity, Nutrition, Stress Management (COPE HEALTH- TEEN ) program will be used in the stress management training to be explained in the program. Receives: Behavioral: Yoga Based Stress Management Program |
| No Intervention | No intervention | The control group will be given 60 minutes of "in the moment" and stress management training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stress level compared to baseline at 3 months.
Stress symptoms experienced by adolescents will be measured by the Perceived Stress Scale. A minimum of 0 and a maximum of 56 points are obtained from the scale. The high total score indicates the high level of stress experienced by the person.
Measured: Basaline, week 1, month 3
Change in anxiety level compared to baseline at 3 months.
Anxiety symptoms experienced by adolescents will be measured with the Beck Anxiety Scale. A minimum score of 0 and a maximum of 63 points is obtained from the scale. The high total score indicates the high level of anxiety experienced by the person.
Measured: Basaline, week 1, month 3
Change in depression level compared to baseline at 3 months.
Depression symptoms experienced by adolescents will be measured with the Reynolds Adolescent Depression Scale. A minimum of 30 and a maximum of 120 points can be obtained from the scale. A high total score indicates that the depression experienced by the person is high.
Measured: Basaline, week 1, month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start18 Apr 2022
- Primary completion18 May 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nesrin arslan, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324709
- Sponsor's protocol ID
- 2022-799
- Status last verified
- Jan 2023
- First submitted
- 17 Mar 2022
- Last updated
- 30 Jan 2023
- 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 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga on Stress Management in Adolescents: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05324709
- Acronym / sponsor ID
- 2022-799
- Conditions
- Adolescent Behavior, Adolescent Problem Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 12 Apr 2022 (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.
The World Health Organization (WHO, 2013) defined the 10-19 age group as "adolescent" and the 15-24 age group as "youth". Adolescence period; It is a period of rapid growth, development and maturation in terms of physical, mental, biochemical and social aspects.10-20% of children and adolescents living in the world have mental health diseases such as generalized anxiety disorders, depression, eating disorders, and post-traumatic stress disorders.In adolescents, yoga is practiced as a relaxing tool to reduce stress, especially for exam anxiety.In Turkey, there are no yoga-based experimental studies to prevent anxiety, stress and depression in adolescents.
Detailed description
The aim of the study is to examine the effect of the Yoga-Based Stress Management Program on the ability to cope with stress in adolescents.Stress management sessions of the Adolescent Health Promotion-Physical Activity, Nutrition, Stress Management (COPE HEALTH-TEEN) program will be used in the stress management training to be explained in the program. There will also be yin yoga exercises.
The general population of the research will be high school senior students in Safranbolu district of Karabük province in the 2021-2022 academic year. First of all, the stress, anxiety and depression levels of the adolescents will be calculated. The research will be carried out in a total of 14 high schools. Each school will be determined as a "cluster" and 7 experimental and 7 control schools will be randomly selected. Simple random draw method will be applied in the selection of experimental and control schools. Adolescents who meet the inclusion criteria will be included in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Yoga Based Stress Management ProgramThe program will be carried out one day a week for four weeks. Yin yoga practices will be applied in the program. Each session will last a total of 40 minutes. The first 20 minutes of yin yoga sessions. Participants will be given training on stress management, breathing and yin yoga. Afterwards, each session of Yin yoga exercises will be started with pranayama (breathing) exercises for 2 minutes, followed by Suryanamaskar-A (Sun Salute-A) for warming up and Yin yoga exercises will be done. The program will be completed by applying the focus on Moment in the last 5 minute. In addition, the participants will be given homework related to the subject of each week. The training booklet will be distributed to the participants before the program. Stress management sessions of the Adolescent Health Promotion-Physical Activity, Nutrition, Stress Management (COPE HEALTH- TEEN ) program will be used in the stress management training to be explained in the program. |
| No Intervention | No intervention | –The control group will be given 60 minutes of "in the moment" and stress management training. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- High school senior student
Key exclusion criteria (1 listed)
- Students with any physical or mental disability • Low levels of perceived stress, anxiety, depression
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 |
|---|---|---|
| Yoga Based Stress Management ProgramYoga-based stress management program is applied to the intervention group. | Behavioural | Experimental |
Primary outcome
Change in stress level compared to baseline at 3 months.
Time frame: Basaline, week 1, month 3
Stress symptoms experienced by adolescents will be measured by the Perceived Stress Scale. A minimum of 0 and a maximum of 56 points are obtained from the scale. The high total score indicates the high level of stress experienced by the person.
Change in anxiety level compared to baseline at 3 months.
Time frame: Basaline, week 1, month 3
Anxiety symptoms experienced by adolescents will be measured with the Beck Anxiety Scale. A minimum score of 0 and a maximum of 63 points is obtained from the scale. The high total score indicates the high level of anxiety experienced by the person.
Change in depression level compared to baseline at 3 months.
Time frame: Basaline, week 1, month 3
Depression symptoms experienced by adolescents will be measured with the Reynolds Adolescent Depression Scale. A minimum of 30 and a maximum of 120 points can be obtained from the scale. A high total score indicates that the depression experienced by the person is high.
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 30 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Adolescent Behavior
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
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 Yoga Based Stress Management Program in people with Adolescent Behavior and Adolescent Problem Behavior, run by Karabuk 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 3 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 30 Jan 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?
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?
Change in stress level compared to baseline at 3 months. (time frame: Basaline, week 1, month 3). The study lists 3 primary outcomes in all. 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 30 Jan 2023.