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Yoga for Chronic Headache in Adolescents

Primary Purpose

Tension Type Headache, Migraine

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Yoga for adolescents
Yoga for parents
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension Type Headache

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Elisabeth Krankenhaus
  • Kinderkrankenhaus St. Marien

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

adolescent yoga / parent control

adolescent waitlist / parent yoga

adolescent yoga / parent yoga

adolescent waitlist / parent control

Arm Description

The adolescent will receive an 12 week yoga course, while one parent will only answer the questionnaires.

One parent will participate in an 12 week yoga course, while the adolescent will receive the intervention after the follow-up period.

Both adolescent and parent will participate in an 12 week yoga course at the same time.

The adolescent will receive the intervention after the follow-up period, while one parent will only answer the questionnaires.

Outcomes

Primary Outcome Measures

Pain frequency adolescent
Measurement of pain frequency after yoga intervention via headache diary

Secondary Outcome Measures

Pain frequency adolescent
Measurement of pain frequency after follow-up period via headache diary
Pain duration adolescent
Measurement of pain duration after yoga intervention via headache diary
Pain duration adolescent
Measurement of pain duration after follow-up period via headache diary
Pain intensity adolescent
Measurement of pain intensity after yoga intervention via headache diary
Pain intensity adolescent
Measurement of pain intensity after follow-up period via headache diary
Quality of life adolescent self-assessment
Measurement of quality of life in self-assessment after yoga intervention via the kidscreen 27 questionnaire
Quality of life adolescent self-assessment
Measurement of quality of life in self-assessment after follow-up period via the kidscreen 27 questionnaire
Quality of life adolescent external assessment
Measurement of quality of life in external assessment by one parent after yoga intervention via the kidscreen 27 questionnaire
Quality of life adolescent external assessment
Measurement of quality of life in external assessment by one parent after follow-up period via the kidscreen 27 questionnaire
Pain disability adolescent self-assessment
Measurement of pain disability in self-assessment after yoga intervention via the paediatric pain disability index (P-PDI)
Pain disability adolescent self-assessment
Measurement of pain disability in self-assessment after follow-up period via the paediatric pain disability index (P-PDI)
Pain disability adolescent external assessment
Measurement of pain disability in external assessment by one parent after yoga intervention via the paediatric pain disability index (P-PDI)
Pain disability adolescent external assessment
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
Measurement of pain coping in self-assessment after yoga intervention via the Paediatric Pain Coping Inventory Revise (PPCI-R)
Pain coping adolescent
Measurement of pain coping in self-assessment after follow-up period via the Paediatric Pain Coping Inventory Revise (PPCI-R)
Depression adolescent
Measurement of Depression in self-assessment after yoga intervention via the Depressions Inventar für Kinder und Jugendliche (DIKJ)
Depression adolescent
Measurement of Depression in self-assessment after follow-up period via the Depressions Inventar für Kinder und Jugendliche (DIKJ)
Stress adolescent
Measurement of Stress in self-assessment after yoga intervention via the Problem Questionnaire (PQ)
Stress adolescent
Measurement of Stress in self-assessment after follow-up period via the Problem Questionnaire (PQ)
Pain catastrophizing parents
Measurement of parents pain catastrophizing in self-assessment by one parent after follow-up period via the Pain Catastrophizing Scale for Parents (PCS-P)
Pain catastrophizing parents
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
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)
Quality of life parents
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
Measurement of parents depression in self-assessment by one parent after yoga intervention via the Beck-Depression-Inventar (BDI)
Depression parents
Measurement of parents depression in self-assessment by one parent after follow-up period via the Beck-Depression-Inventar (BDI)
Stress parents
Measurement of parents stress in self-assessment by one parent after yoga intervention via the Cohen's Perceived Stress Scale (PSS-10)
Stress parents
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
Adverse events within the yoga course period of adolescents
Adverse events parents
Adverse events within the yoga course period of parents

Full Information

First Posted
March 17, 2016
Last Updated
July 24, 2017
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT02721849
Brief Title
Yoga for Chronic Headache in Adolescents
Official Title
Randomisierte Kontrollierte Studie Zur Wirkung Von Yoga Bei Chronischen Kopfschmerzen im Jugendalter
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension Type Headache, Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adolescent yoga / parent control
Arm Type
Experimental
Arm Description
The adolescent will receive an 12 week yoga course, while one parent will only answer the questionnaires.
Arm Title
adolescent waitlist / parent yoga
Arm Type
Experimental
Arm Description
One parent will participate in an 12 week yoga course, while the adolescent will receive the intervention after the follow-up period.
Arm Title
adolescent yoga / parent yoga
Arm Type
Experimental
Arm Description
Both adolescent and parent will participate in an 12 week yoga course at the same time.
Arm Title
adolescent waitlist / parent control
Arm Type
No Intervention
Arm Description
The adolescent will receive the intervention after the follow-up period, while one parent will only answer the questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Yoga for adolescents
Intervention Description
12 week hatha yoga course for adolescents
Intervention Type
Behavioral
Intervention Name(s)
Yoga for parents
Intervention Description
12 week hatha yoga course
Primary Outcome Measure Information:
Title
Pain frequency adolescent
Description
Measurement of pain frequency after yoga intervention via headache diary
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Pain frequency adolescent
Description
Measurement of pain frequency after follow-up period via headache diary
Time Frame
Week 24
Title
Pain duration adolescent
Description
Measurement of pain duration after yoga intervention via headache diary
Time Frame
Week 12
Title
Pain duration adolescent
Description
Measurement of pain duration after follow-up period via headache diary
Time Frame
Week 24
Title
Pain intensity adolescent
Description
Measurement of pain intensity after yoga intervention via headache diary
Time Frame
Week 12
Title
Pain intensity adolescent
Description
Measurement of pain intensity after follow-up period via headache diary
Time Frame
Week 24
Title
Quality of life adolescent self-assessment
Description
Measurement of quality of life in self-assessment after yoga intervention via the kidscreen 27 questionnaire
Time Frame
Week 12
Title
Quality of life adolescent self-assessment
Description
Measurement of quality of life in self-assessment after follow-up period via the kidscreen 27 questionnaire
Time Frame
Week 24
Title
Quality of life adolescent external assessment
Description
Measurement of quality of life in external assessment by one parent after yoga intervention via the kidscreen 27 questionnaire
Time Frame
Week 12
Title
Quality of life adolescent external assessment
Description
Measurement of quality of life in external assessment by one parent after follow-up period via the kidscreen 27 questionnaire
Time Frame
Week 24
Title
Pain disability adolescent self-assessment
Description
Measurement of pain disability in self-assessment after yoga intervention via the paediatric pain disability index (P-PDI)
Time Frame
Week 12
Title
Pain disability adolescent self-assessment
Description
Measurement of pain disability in self-assessment after follow-up period via the paediatric pain disability index (P-PDI)
Time Frame
Week 24
Title
Pain disability adolescent external assessment
Description
Measurement of pain disability in external assessment by one parent after yoga intervention via the paediatric pain disability index (P-PDI)
Time Frame
Week 12
Title
Pain disability adolescent external assessment
Description
Measurement of pain disability in external assessment by one parent after follow-up period via the paediatric pain disability index (P-PDI)
Time Frame
Week 24
Title
Pain coping adolescent
Description
Measurement of pain coping in self-assessment after yoga intervention via the Paediatric Pain Coping Inventory Revise (PPCI-R)
Time Frame
Week 12
Title
Pain coping adolescent
Description
Measurement of pain coping in self-assessment after follow-up period via the Paediatric Pain Coping Inventory Revise (PPCI-R)
Time Frame
Week 24
Title
Depression adolescent
Description
Measurement of Depression in self-assessment after yoga intervention via the Depressions Inventar für Kinder und Jugendliche (DIKJ)
Time Frame
Week 12
Title
Depression adolescent
Description
Measurement of Depression in self-assessment after follow-up period via the Depressions Inventar für Kinder und Jugendliche (DIKJ)
Time Frame
Week 24
Title
Stress adolescent
Description
Measurement of Stress in self-assessment after yoga intervention via the Problem Questionnaire (PQ)
Time Frame
Week 12
Title
Stress adolescent
Description
Measurement of Stress in self-assessment after follow-up period via the Problem Questionnaire (PQ)
Time Frame
Week 24
Title
Pain catastrophizing parents
Description
Measurement of parents pain catastrophizing in self-assessment by one parent after follow-up period via the Pain Catastrophizing Scale for Parents (PCS-P)
Time Frame
Week 12
Title
Pain catastrophizing parents
Description
Measurement of parents pain catastrophizing in self-assessment by one parent after follow-up period via the Pain Catastrophizing Scale for Parents (PCS-P)
Time Frame
Week 24
Title
Quality of life parents
Description
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)
Time Frame
Week 12
Title
Quality of life parents
Description
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)
Time Frame
Week 24
Title
Depression parents
Description
Measurement of parents depression in self-assessment by one parent after yoga intervention via the Beck-Depression-Inventar (BDI)
Time Frame
Week 12
Title
Depression parents
Description
Measurement of parents depression in self-assessment by one parent after follow-up period via the Beck-Depression-Inventar (BDI)
Time Frame
Week 24
Title
Stress parents
Description
Measurement of parents stress in self-assessment by one parent after yoga intervention via the Cohen's Perceived Stress Scale (PSS-10)
Time Frame
Week 12
Title
Stress parents
Description
Measurement of parents stress in self-assessment by one parent after follow-up period via the Cohen's Perceived Stress Scale (PSS-10)
Time Frame
Week 24
Title
Adverse events adolescent
Description
Adverse events within the yoga course period of adolescents
Time Frame
Week 12
Title
Adverse events parents
Description
Adverse events within the yoga course period of parents
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Elisabeth Krankenhaus
City
Essen
Country
Germany
Facility Name
Kinderkrankenhaus St. Marien
City
Landshut
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Yoga for Chronic Headache in Adolescents

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