NCT03796754

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

January 2, 2019

Last Update Submit

September 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Change baseline, 4 months

Secondary Outcomes (5)

  • Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children)

    Change Baseline, 4 months, 12 months

  • Perceived Stress Scale (PSS)

    Change Baseline, 4 months, 12 months

  • Teacher anxiety and stress inventory (LASI)

    Change Baseline, 4 months, 12 months

  • Screening for somatoform disorders of childhood and adolescence (SOMS-E)

    Change Baseline, 4 months, 12 months

  • Inventory of the quality of life of children and adolescents (KIDSCREEN-52 parents)

    Change Baseline, 4 months, 12 months

Other Outcomes (2)

  • Heart rate variability

    Baseline, 4 months, 12 months

  • Qualitative interviews

    4 months, 12 months

Study Arms (2)

YoBEKA Intervention

ACTIVE COMPARATOR
Behavioral: YoBEKA

Control group

NO INTERVENTION

Interventions

YoBEKABEHAVIORAL

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.

YoBEKA Intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Students from participating primary schools in Berlin aged 6-12 years
  • Written declaration of consent of the parent or legal guardian

You may not qualify if:

  • Serious chronic or acute diseases
  • Immobility or serious restriction for gymnastic exercises due to orthopaedic, neurological or other medical causes
  • Participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, 14109, Germany

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 8, 2019

Study Start

January 21, 2019

Primary Completion

February 15, 2020

Study Completion

February 15, 2020

Last Updated

September 29, 2022

Record last verified: 2022-09

Locations