Yoga for Chronic Headache in Adolescents

Not Applicable

Completed

• Conditions: Migraine; Tension Type Headache
• Interventions: Behavioral: Yoga for adolescents; Behavioral: Yoga for parents

• Registration Number: NCT02721849
• Lead Sponsor: Universität Duisburg-Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-29
• Study Start: 2016-04
• Primary Completion: 2017-03
• Status Verified: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
adolescent yoga / parent yoga	Yoga for parents	Both adolescent and parent will participate in an 12 week yoga course at the same time.
adolescent yoga / parent control	Yoga for adolescents	The adolescent will receive an 12 week yoga course, while one parent will only answer the questionnaires.
adolescent waitlist / parent yoga	Yoga for parents	One parent will participate in an 12 week yoga course, while the adolescent will receive the intervention after the follow-up period.
adolescent yoga / parent yoga	Yoga for adolescents	Both adolescent and parent will participate in an 12 week yoga course at the same time.

Primary Outcome Measures

Name	Time	Method
Pain frequency adolescent	Week 12	Measurement of pain frequency after yoga intervention via headache diary

Secondary Outcome Measures

Name	Time	Method
Pain disability adolescent self-assessment	Week 24	Measurement of pain disability in self-assessment after follow-up period via the paediatric pain disability index (P-PDI)
Pain disability adolescent external assessment	Week 24	Measurement of pain disability in external assessment by one parent after follow-up period via the paediatric pain disability index (P-PDI)
Pain coping adolescent	Week 24	Measurement of pain coping in self-assessment after follow-up period 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
Pain duration adolescent	Week 24	Measurement of pain duration after follow-up period via headache diary
Pain intensity adolescent	Week 24	Measurement of pain intensity after follow-up period via headache diary
Quality of life adolescent self-assessment	Week 24	Measurement of quality of life in self-assessment after follow-up period via the kidscreen 27 questionnaire
Quality of life adolescent external assessment	Week 24	Measurement of quality of life in external assessment by one parent after follow-up period via the kidscreen 27 questionnaire
Depression adolescent	Week 24	Measurement of Depression in self-assessment after follow-up period via the Depressions Inventar für Kinder und Jugendliche (DIKJ)
Stress adolescent	Week 24	Measurement of Stress in self-assessment after follow-up period via the Problem Questionnaire (PQ)
Pain catastrophizing parents	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)
Quality of life parents	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)
Depression parents	Week 24	Measurement of parents depression in self-assessment by one parent after follow-up period via the Beck-Depression-Inventar (BDI)
Stress parents	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)
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

Trial Locations

Locations (2)

Kinderkrankenhaus St. Marien; 🇩🇪 Landshut, Germany

Elisabeth Krankenhaus; 🇩🇪 Essen, Germany