Skip to main content
OpenTrials
Completed

NCT Number: NCT02721849

Yoga for Chronic Headache in Adolescents

A randomized controlled trial to investigate the efficacy of yoga on tension type headache and / or migraine in adolescents between 12 and 16 years, consisting of a four group design which includes an 12 week yoga course and a three-month follow-up period. Both adolescent and one parent will be randomized either to yoga or no treatment. Primary outcome will be pain frequency in adolescents considering pain catastrophizing of parents.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tension Type Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Nervous System Diseases Tension-Type Headache

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elisabeth Krankenhaus, Essen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adolescent:

  • tension type headache and/or migraine minimum at 4 days per month
  • willingness to participate at least 10 out of 12 yoga sessions
  • physical and cognitive ability to participate in light physical, breathing and relaxation exercises
  • good german language

Parents:

  • willingness to participate at least 10 out of 12 yoga sessions
  • physical and cognitive ability to participate in light physical, breathing and relaxation exercises
  • good german language

Exclusion criteria

  • pregnancy or lactation
  • attending a yoga class within the last 3 months prior to the study

Treatment and study plan

Yoga for adolescents

Behavioral

12 week hatha yoga course for adolescents

Yoga for parents

Behavioral

12 week hatha yoga course

Primary outcomes

  1. Pain frequency adolescent

    Time frame: Week 12

    Measurement of pain frequency after yoga intervention via headache diary

Secondary outcomes

  1. Pain frequency adolescent

    Time frame: Week 24

    Measurement of pain frequency after follow-up period via headache diary

  2. Pain duration adolescent

    Time frame: Week 12

    Measurement of pain duration after yoga intervention via headache diary

  3. Pain duration adolescent

    Time frame: Week 24

    Measurement of pain duration after follow-up period via headache diary

  4. Pain intensity adolescent

    Time frame: Week 12

    Measurement of pain intensity after yoga intervention via headache diary

  5. Pain intensity adolescent

    Time frame: Week 24

    Measurement of pain intensity after follow-up period via headache diary

  6. Quality of life adolescent self-assessment

    Time frame: Week 12

    Measurement of quality of life in self-assessment after yoga intervention via the kidscreen 27 questionnaire

  7. Quality of life adolescent self-assessment

    Time frame: Week 24

    Measurement of quality of life in self-assessment after follow-up period via the kidscreen 27 questionnaire

  8. Quality of life adolescent external assessment

    Time frame: Week 12

    Measurement of quality of life in external assessment by one parent after yoga intervention via the kidscreen 27 questionnaire

  9. Quality of life adolescent external assessment

    Time frame: Week 24

    Measurement of quality of life in external assessment by one parent after follow-up period via the kidscreen 27 questionnaire

  10. Pain disability adolescent self-assessment

    Time frame: Week 12

    Measurement of pain disability in self-assessment after yoga intervention via the paediatric pain disability index (P-PDI)

  11. Pain disability adolescent self-assessment

    Time frame: Week 24

    Measurement of pain disability in self-assessment after follow-up period via the paediatric pain disability index (P-PDI)

  12. Pain disability adolescent external assessment

    Time frame: Week 12

    Measurement of pain disability in external assessment by one parent after yoga intervention via the paediatric pain disability index (P-PDI)

  13. Pain disability adolescent external assessment

    Time frame: Week 24

    Measurement of pain disability in external assessment by one parent after follow-up period via the paediatric pain disability index (P-PDI)

  14. Pain coping adolescent

    Time frame: Week 12

    Measurement of pain coping in self-assessment after yoga intervention via the Paediatric Pain Coping Inventory Revise (PPCI-R)

  15. Pain coping adolescent

    Time frame: Week 24

    Measurement of pain coping in self-assessment after follow-up period via the Paediatric Pain Coping Inventory Revise (PPCI-R)

  16. Depression adolescent

    Time frame: Week 12

    Measurement of Depression in self-assessment after yoga intervention via the Depressions Inventar für Kinder und Jugendliche (DIKJ)

  17. Depression adolescent

    Time frame: Week 24

    Measurement of Depression in self-assessment after follow-up period via the Depressions Inventar für Kinder und Jugendliche (DIKJ)

  18. Stress adolescent

    Time frame: Week 12

    Measurement of Stress in self-assessment after yoga intervention via the Problem Questionnaire (PQ)

  19. Stress adolescent

    Time frame: Week 24

    Measurement of Stress in self-assessment after follow-up period via the Problem Questionnaire (PQ)

  20. Pain catastrophizing parents

    Time frame: Week 12

    Measurement of parents pain catastrophizing in self-assessment by one parent after follow-up period via the Pain Catastrophizing Scale for Parents (PCS-P)

  21. Pain catastrophizing parents

    Time frame: Week 24

    Measurement of parents pain catastrophizing in self-assessment by one parent after follow-up period via the Pain Catastrophizing Scale for Parents (PCS-P)

  22. Quality of life parents

    Time frame: Week 12

    Measurement of parents quality of life in self-assessment by one parent after yoga intervention via the WHO Quality of Life Bref questionnaire (WHOQol-Bref)

  23. Quality of life parents

    Time frame: Week 24

    Measurement of parents quality of life in self-assessment by one parent after follow-up period via the WHO Quality of Life Bref questionnaire (WHOQol-Bref)

  24. Depression parents

    Time frame: Week 12

    Measurement of parents depression in self-assessment by one parent after yoga intervention via the Beck-Depression-Inventar (BDI)

  25. Depression parents

    Time frame: Week 24

    Measurement of parents depression in self-assessment by one parent after follow-up period via the Beck-Depression-Inventar (BDI)

  26. Stress parents

    Time frame: Week 12

    Measurement of parents stress in self-assessment by one parent after yoga intervention via the Cohen's Perceived Stress Scale (PSS-10)

  27. Stress parents

    Time frame: Week 24

    Measurement of parents stress in self-assessment by one parent after follow-up period via the Cohen's Perceived Stress Scale (PSS-10)

  28. Adverse events adolescent

    Time frame: Week 12

    Adverse events within the yoga course period of adolescents

  29. Adverse events parents

    Time frame: Week 12

    Adverse events within the yoga course period of parents

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Randomisierte Kontrollierte Studie Zur Wirkung Von Yoga Bei Chronischen Kopfschmerzen im Jugendalter

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2016
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.