Clinical trial NCT02721849: Yoga for Chronic Headache in Adolescents
Official title: Randomisierte Kontrollierte Studie Zur Wirkung Von Yoga Bei Chronischen Kopfschmerzen im Jugendalter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension Type Headache
Migraine
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain frequency adolescent
timeFrame: Week 12
Secondary outcomes:
measure: Pain frequency adolescent
timeFrame: Week 24
measure: Pain duration adolescent
timeFrame: Week 12
measure: Pain duration adolescent
timeFrame: Week 24
measure: Pain intensity adolescent
timeFrame: Week 12
measure: Pain intensity adolescent
timeFrame: Week 24
measure: Quality of life adolescent self-assessment
timeFrame: Week 12
measure: Quality of life adolescent self-assessment
timeFrame: Week 24
measure: Quality of life adolescent external assessment
timeFrame: Week 12
measure: Quality of life adolescent external assessment
timeFrame: Week 24
measure: Pain disability adolescent self-assessment
timeFrame: Week 12
measure: Pain disability adolescent self-assessment
timeFrame: Week 24
measure: Pain disability adolescent external assessment
timeFrame: Week 12
measure: Pain disability adolescent external assessment
timeFrame: Week 24
measure: Pain coping adolescent
timeFrame: Week 12
measure: Pain coping adolescent
timeFrame: Week 24
measure: Depression adolescent
timeFrame: Week 12
measure: Depression adolescent
timeFrame: Week 24
measure: Stress adolescent
timeFrame: Week 12
measure: Stress adolescent
timeFrame: Week 24
measure: Pain catastrophizing parents
timeFrame: Week 12
measure: Pain catastrophizing parents
timeFrame: Week 24
measure: Quality of life parents
timeFrame: Week 12
measure: Quality of life parents
timeFrame: Week 24
measure: Depression parents
timeFrame: Week 12
measure: Depression parents
timeFrame: Week 24
measure: Stress parents
timeFrame: Week 12
measure: Stress parents
timeFrame: Week 24
measure: Adverse events adolescent
timeFrame: Week 12
measure: Adverse events parents
timeFrame: Week 12
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Elisabeth Krankenhaus
city: Landshut
country: Germany
facility: Kinderkrankenhaus St. Marien
Study officials:
References: