Stress, PsychologicalNCT03796754
YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) in Elementary Schools
A study testing YoBEKA in people with Stress, Psychological, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress reduction and concomitant psychological parameters. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- YoBEKA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jan 2019to 15 Feb 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Students from participating primary schools in Berlin aged 6-12 years
- Written declaration of consent of the parent or legal guardian
Who cannot join
- Serious chronic or acute diseases
- Immobility or serious restriction for gymnastic exercises due to orthopaedic, neurological or other medical causes
- Participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integration of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) Into Elementary Schools in Germany
The aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress reduction and concomitant psychological parameters.
- Conditions
- Stress, Psychological
- Being tested
- YoBEKA
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YoBEKABehavioural
The teachers and students of the YoBEKA study arm receive a guided YoBEKA practice from an experienced YoBEKA trainer during the regular 4 month intervention period. The YoBEKA program is based on a combination of different, easy to perform exercises appropriate to the school situation, consisting of postures, verses for speech, song and movement, affirmations in movement to promote balance and coordination, and various rest and silence exercises to promote body awareness and relaxation techniques. The teaching is ideologically neutral and without religious background. The participating teachers receive an initial two-hour YoBEKA introductory course. Every 2 weeks there is a one to two-hour training course. The pedagogical specialists are supported once a week by an experienced YoBEKA trainer. The teachers are encouraged to integrate the learned exercises independently and regularly into their everyday school life.
| Study group | Role | What they receive |
|---|---|---|
| YoBEKA Intervention | Active comparator | Not described Receives: Behavioral: YoBEKA |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)
Filled out by students, assessing composite score (range 29-94): subscale 1 (stress-vulnerability [range 7-28]) summed with subscale 3 (stress symptoms and well-being [range 22-66]), lower score meaning a better outcome
Measured: Change baseline, 4 months
Secondary outcomes (5)
Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children)
Filled out by students, assessing full scale, range 27-135, lower score meaning a better outcome
Measured: Change Baseline, 4 months, 12 months
Perceived Stress Scale (PSS)
Filled out by teachers, assessing full scale, range 0-40, lower score meaning a better outcome
Measured: Change Baseline, 4 months, 12 months
Teacher anxiety and stress inventory (LASI)
Filled out by teachers, assessing LASI 2, range 46-230, higher score meaning a better outcome
Measured: Change Baseline, 4 months, 12 months
Screening for somatoform disorders of childhood and adolescence (SOMS-E)
Filled out by parents, assessing full scale, range 55-110, lower score meaning a better outcome
Measured: Change Baseline, 4 months, 12 months
Inventory of the quality of life of children and adolescents (KIDSCREEN-52 parents)
Filled out by parents, assessing full scale, range 27-135, lower score meaning a better outcome
Measured: Change Baseline, 4 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start21 Jan 2019
- Primary completion15 Feb 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796754
- Sponsor's protocol ID
- YoBEKA
- Status last verified
- Sep 2022
- First submitted
- 2 Jan 2019
- Last updated
- 29 Sep 2022
- 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 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) Into Elementary Schools in Germany
- ClinicalTrials.gov ID
- NCT03796754
- Acronym / sponsor ID
- YoBEKA
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 8 Jan 2019 (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 aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress reduction and concomitant psychological parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YoBEKA Intervention | Active comparator | Behavioral: YoBEKA |
| Control group | No intervention | – |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Students from participating primary schools in Berlin aged 6-12 years
- Written declaration of consent of the parent or legal guardian
Key exclusion criteria (3 listed)
- Serious chronic or acute diseases
- Immobility or serious restriction for gymnastic exercises due to orthopaedic, neurological or other medical causes
- Participation in another 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 |
|---|---|---|
| YoBEKAThe teachers and students of the YoBEKA study arm receive a guided YoBEKA practice from an experienced YoBEKA trainer during the regular 4 month intervention period. The YoBEKA program is based on a combination of different, easy to perform exercises appropriate to the school situation, consisting of postures, verses for speech, song and movement, affirmations in movement to promote balance and coordination, and various rest and silence exercises to promote body awareness and relaxation techniques. The teaching is ideologically neutral and without religious background. The participating teachers receive an initial two-hour YoBEKA introductory course. Every 2 weeks there is a one to two-hour training course. The pedagogical specialists are supported once a week by an experienced YoBEKA trainer. The teachers are encouraged to integrate the learned exercises independently and regularly into their everyday school life. | Behavioural | YoBEKA Intervention |
Primary outcome
Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)
Time frame: Change baseline, 4 months
Filled out by students, assessing composite score (range 29-94): subscale 1 (stress-vulnerability [range 7-28]) summed with subscale 3 (stress symptoms and well-being [range 22-66]), lower score meaning a better outcome
5 secondary outcomes
Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children)
Time frame: Change Baseline, 4 months, 12 months
Perceived Stress Scale (PSS)
Time frame: Change Baseline, 4 months, 12 months
Teacher anxiety and stress inventory (LASI)
Time frame: Change Baseline, 4 months, 12 months
Screening for somatoform disorders of childhood and adolescence (SOMS-E)
Time frame: Change Baseline, 4 months, 12 months
Inventory of the quality of life of children and adolescents (KIDSCREEN-52 parents)
Time frame: Change Baseline, 4 months, 12 months
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 29 Sep 2022.
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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.
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 YoBEKA in people with Stress, Psychological, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 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 29 Sep 2022. 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 Germany. 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?
Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R) (time frame: Change baseline, 4 months). 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 29 Sep 2022.