Migraine, Tension Type Headache
Conditions
Brief summary
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.
Interventions
BEHAVIORALYoga for adolescents
12 week hatha yoga course for adolescents
BEHAVIORALYoga for parents
12 week hatha yoga course
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain frequency adolescent | Week 12 | Measurement of pain frequency after yoga intervention via headache diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain duration adolescent | Week 12 | Measurement of pain duration after yoga intervention via headache diary |
| Pain intensity adolescent | Week 12 | Measurement of pain intensity after yoga intervention via headache diary |
| Quality of life adolescent self-assessment | Week 12 | Measurement of quality of life in self-assessment after yoga intervention via the kidscreen 27 questionnaire |
| Quality of life adolescent external assessment | Week 12 | Measurement of quality of life in external assessment by one parent after yoga intervention via the kidscreen 27 questionnaire |
| Pain disability adolescent self-assessment | Week 12 | Measurement of pain disability in self-assessment after yoga intervention via the paediatric pain disability index (P-PDI) |
| Pain disability adolescent external assessment | Week 12 | Measurement of pain disability in external assessment by one parent after yoga intervention via the paediatric pain disability index (P-PDI) |
| Pain coping adolescent | Week 12 | Measurement of pain coping in self-assessment after yoga intervention via the Paediatric Pain Coping Inventory Revise (PPCI-R) |
| Pain frequency adolescent | Week 24 | Measurement of pain frequency after follow-up period via headache diary |
| Stress adolescent | Week 12 | Measurement of Stress in self-assessment after yoga intervention via the Problem Questionnaire (PQ) |
| Pain catastrophizing parents | 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) |
| Quality of life parents | 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) |
| Depression parents | Week 12 | Measurement of parents depression in self-assessment by one parent after yoga intervention via the Beck-Depression-Inventar (BDI) |
| Stress parents | Week 12 | Measurement of parents stress in self-assessment by one parent after yoga intervention via the Cohen's Perceived Stress Scale (PSS-10) |
| Adverse events adolescent | Week 12 | Adverse events within the yoga course period of adolescents |
| Adverse events parents | Week 12 | Adverse events within the yoga course period of parents |
| Depression adolescent | Week 12 | Measurement of Depression in self-assessment after yoga intervention via the Depressions Inventar für Kinder und Jugendliche (DIKJ) |
Countries
Germany
Outcome results
None listed