Tension Type HeadacheNCT02721849
Yoga for Chronic Headache in Adolescents
A study testing Yoga for adolescents and Yoga for parents in people with Tension Type Headache and Migraine, run by Universität Duisburg-Essen at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Tension Type Headache, Migraine
- What is being tested?
- Yoga for adolescents and Yoga for parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- pregnancy or lactation
- attending a yoga class within the last 3 months prior to the study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Elisabeth Krankenhaus
Essen
Kinderkrankenhaus St. Marien
Landshut
About this study
Official title: 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.
- Conditions
- Tension Type Headache, Migraine
- Being tested
- Yoga for adolescents, Yoga for parents
- Medical subject headings
- Tension-Type Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga for adolescentsBehavioural
12 week hatha yoga course for adolescents
Yoga for parentsBehavioural
12 week hatha yoga course
| Study group | Role | What they receive |
|---|---|---|
| adolescent yoga / parent control | Experimental | The adolescent will receive an 12 week yoga course, while one parent will only answer the questionnaires. Receives: Behavioral: Yoga for adolescents |
| adolescent waitlist / parent yoga | Experimental | One parent will participate in an 12 week yoga course, while the adolescent will receive the intervention after the follow-up period. Receives: Behavioral: Yoga for parents |
| adolescent yoga / parent yoga | Experimental | Both adolescent and parent will participate in an 12 week yoga course at the same time. Receives: Behavioral: Yoga for adolescents; Behavioral: Yoga for parents |
| adolescent waitlist / parent control | No intervention | The adolescent will receive the intervention after the follow-up period, while one parent will only answer the questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain frequency adolescent
Measurement of pain frequency after yoga intervention via headache diary
Measured: Week 12
Secondary outcomes (29)
Pain frequency adolescent
Measurement of pain frequency after follow-up period via headache diary
Measured: Week 24
Pain duration adolescent
Measurement of pain duration after yoga intervention via headache diary
Measured: Week 12
Pain duration adolescent
Measurement of pain duration after follow-up period via headache diary
Measured: Week 24
Pain intensity adolescent
Measurement of pain intensity after yoga intervention via headache diary
Measured: Week 12
Pain intensity adolescent
Measurement of pain intensity after follow-up period via headache diary
Measured: Week 24
Quality of life adolescent self-assessment
Measurement of quality of life in self-assessment after yoga intervention via the kidscreen 27 questionnaire
Measured: Week 12
Quality of life adolescent self-assessment
Measurement of quality of life in self-assessment after follow-up period via the kidscreen 27 questionnaire
Measured: Week 24
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
Measured: Week 12
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
Measured: Week 24
Pain disability adolescent self-assessment
Measurement of pain disability in self-assessment after yoga intervention via the paediatric pain disability index (P-PDI)
Measured: Week 12
Pain disability adolescent self-assessment
Measurement of pain disability in self-assessment after follow-up period via the paediatric pain disability index (P-PDI)
Measured: Week 24
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)
Measured: Week 12
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)
Measured: Week 24
Pain coping adolescent
Measurement of pain coping in self-assessment after yoga intervention via the Paediatric Pain Coping Inventory Revise (PPCI-R)
Measured: Week 12
Pain coping adolescent
Measurement of pain coping in self-assessment after follow-up period via the Paediatric Pain Coping Inventory Revise (PPCI-R)
Measured: Week 24
Depression adolescent
Measurement of Depression in self-assessment after yoga intervention via the Depressions Inventar für Kinder und Jugendliche (DIKJ)
Measured: Week 12
Depression adolescent
Measurement of Depression in self-assessment after follow-up period via the Depressions Inventar für Kinder und Jugendliche (DIKJ)
Measured: Week 24
Stress adolescent
Measurement of Stress in self-assessment after yoga intervention via the Problem Questionnaire (PQ)
Measured: Week 12
Stress adolescent
Measurement of Stress in self-assessment after follow-up period via the Problem Questionnaire (PQ)
Measured: Week 24
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)
Measured: Week 12
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)
Measured: Week 24
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)
Measured: Week 12
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)
Measured: Week 24
Depression parents
Measurement of parents depression in self-assessment by one parent after yoga intervention via the Beck-Depression-Inventar (BDI)
Measured: Week 12
Depression parents
Measurement of parents depression in self-assessment by one parent after follow-up period via the Beck-Depression-Inventar (BDI)
Measured: Week 24
Stress parents
Measurement of parents stress in self-assessment by one parent after yoga intervention via the Cohen's Perceived Stress Scale (PSS-10)
Measured: Week 12
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)
Measured: Week 24
Adverse events adolescent
Adverse events within the yoga course period of adolescents
Measured: Week 12
Adverse events parents
Adverse events within the yoga course period of parents
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721849
- Sponsor's protocol ID
- 15-6736
- Status last verified
- Jul 2017
- First submitted
- 17 Mar 2016
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomisierte Kontrollierte Studie Zur Wirkung Von Yoga Bei Chronischen Kopfschmerzen im Jugendalter
- ClinicalTrials.gov ID
- NCT02721849
- Acronym / sponsor ID
- 15-6736
- Conditions
- Tension Type Headache, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| adolescent yoga / parent control | Experimental | Behavioral: Yoga for adolescentsThe adolescent will receive an 12 week yoga course, while one parent will only answer the questionnaires. |
| adolescent waitlist / parent yoga | Experimental | Behavioral: Yoga for parentsOne 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 | Experimental | Behavioral: Yoga for adolescents, Behavioral: Yoga for parentsBoth adolescent and parent will participate in an 12 week yoga course at the same time. |
| adolescent waitlist / parent control | No intervention | –The adolescent will receive the intervention after the follow-up period, while one parent will only answer the questionnaires. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
- willingness to participate at least 10 out of 12 yoga sessions
Key exclusion criteria (2 listed)
- pregnancy or lactation
- attending a yoga class within the last 3 months prior to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga for adolescents12 week hatha yoga course for adolescents | Behavioural | adolescent yoga / parent control, adolescent yoga / parent yoga |
| Yoga for parents12 week hatha yoga course | Behavioural | adolescent waitlist / parent yoga, adolescent yoga / parent yoga |
Primary outcome
Pain frequency adolescent
Time frame: Week 12
Measurement of pain frequency after yoga intervention via headache diary
29 secondary outcomes
Pain frequency adolescent
Time frame: Week 24
Pain duration adolescent
Time frame: Week 12
Pain duration adolescent
Time frame: Week 24
Pain intensity adolescent
Time frame: Week 12
Pain intensity adolescent
Time frame: Week 24
Quality of life adolescent self-assessment
Time frame: Week 12
Quality of life adolescent self-assessment
Time frame: Week 24
Quality of life adolescent external assessment
Time frame: Week 12
Quality of life adolescent external assessment
Time frame: Week 24
Pain disability adolescent self-assessment
Time frame: Week 12
Pain disability adolescent self-assessment
Time frame: Week 24
Pain disability adolescent external assessment
Time frame: Week 12
Pain disability adolescent external assessment
Time frame: Week 24
Pain coping adolescent
Time frame: Week 12
Pain coping adolescent
Time frame: Week 24
Depression adolescent
Time frame: Week 12
Depression adolescent
Time frame: Week 24
Stress adolescent
Time frame: Week 12
Stress adolescent
Time frame: Week 24
Pain catastrophizing parents
Time frame: Week 12
Pain catastrophizing parents
Time frame: Week 24
Quality of life parents
Time frame: Week 12
Quality of life parents
Time frame: Week 24
Depression parents
Time frame: Week 12
Depression parents
Time frame: Week 24
Stress parents
Time frame: Week 12
Stress parents
Time frame: Week 24
Adverse events adolescent
Time frame: Week 12
Adverse events parents
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga for adolescents and Yoga for parents in people with Tension Type Headache and Migraine, run by Universität Duisburg-Essen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain frequency adolescent (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.