Yoga for Chronic Headache in Adolescents

July 24, 2017 updated by: Holger Cramer, Universität Duisburg-Essen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany
        • Elisabeth Krankenhaus
      • Landshut, Germany
        • Kinderkrankenhaus St. Marien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: adolescent yoga / parent control
The adolescent will receive an 12 week yoga course, while one parent will only answer the questionnaires.
Behavioral: Yoga for adolescents
12 week hatha yoga course for adolescents
Experimental: adolescent waitlist / parent yoga
One parent will participate in an 12 week yoga course, while the adolescent will receive the intervention after the follow-up period.
Behavioral: Yoga for parents
12 week hatha yoga course
Experimental: adolescent yoga / parent yoga
Both adolescent and parent will participate in an 12 week yoga course at the same time.
Behavioral: Yoga for adolescents
12 week hatha yoga course for adolescents
Behavioral: Yoga for parents
12 week hatha yoga course
No Intervention: adolescent waitlist / parent control
The adolescent will receive the intervention after the follow-up period, while one parent will only answer the questionnaires.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain frequency adolescent
Time Frame: Week 12
Measurement of pain frequency after yoga intervention via headache diary
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain frequency adolescent
Time Frame: Week 24
Measurement of pain frequency after follow-up period via headache diary
Week 24
Pain duration adolescent
Time Frame: Week 12
Measurement of pain duration after yoga intervention via headache diary
Week 12
Pain duration adolescent
Time Frame: Week 24
Measurement of pain duration after follow-up period via headache diary
Week 24
Pain intensity adolescent
Time Frame: Week 12
Measurement of pain intensity after yoga intervention via headache diary
Week 12
Pain intensity adolescent
Time Frame: Week 24
Measurement of pain intensity after follow-up period via headache diary
Week 24
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
Week 12
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
Week 24
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
Week 12
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
Week 24
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)
Week 12
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)
Week 24
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)
Week 12
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)
Week 24
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)
Week 12
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)
Week 24
Depression adolescent
Time Frame: Week 12
Measurement of Depression in self-assessment after yoga intervention via the Depressions Inventar für Kinder und Jugendliche (DIKJ)
Week 12
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)
Week 24
Stress adolescent
Time Frame: Week 12
Measurement of Stress in self-assessment after yoga intervention via the Problem Questionnaire (PQ)
Week 12
Stress adolescent
Time Frame: Week 24
Measurement of Stress in self-assessment after follow-up period via the Problem Questionnaire (PQ)
Week 24
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)
Week 12
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)
Week 24
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)
Week 12
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)
Week 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)
Week 12
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)
Week 24
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)
Week 12
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)
Week 24
Adverse events adolescent
Time Frame: Week 12
Adverse events within the yoga course period of adolescents
Week 12
Adverse events parents
Time Frame: Week 12
Adverse events within the yoga course period of parents
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universität Duisburg-Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-6736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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