HeadacheNCT00726843
Evaluation of Yoga for the Treatment of Pediatric Headaches
A study testing 8 weeks of Iyengar Yoga in people with Headache, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study will examine the feasibility and acceptability of yoga for adolescents seen by a medical practitioner for their headaches. The study will also examine whether yoga decreases anxiety and improves quality of life. We hypothesize that yoga will be both acceptable and feasible with a pediatric population. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Headache
- What is being tested?
- 8 weeks of Iyengar Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2009
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 13-17 years
- patient seen in the headache clinic at Children's Hospital of Wisconsin
Who cannot join
- neck, spinal, or back injuries
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
This study will examine the feasibility and acceptability of yoga for adolescents seen by a medical practitioner for their headaches. The study will also examine whether yoga decreases anxiety and improves quality of life. We hypothesize that yoga will be both acceptable and feasible with a pediatric population. We also hypothesize that yoga will decrease anxiety and improve quality of life.
- Conditions
- Headache
- Being tested
- 8 weeks of Iyengar Yoga
- Keywords
- Headache, Complementary and Alternative Medicine, Pediatric, Yoga
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 weeks of Iyengar YogaOther
Participants will attend 8 weekly, 75 min. yoga sessions, followed by 8 weeks of follow-up (will provide headache frequency/intensity)
8 weeks of Iyengar YogaOther
Participants will provide headache frequency/intensity for 8 weeks, followed by 8 weekly, 75 min. yoga sessions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 8 weeks of Yoga, followed by 8 weeks of follow-up Receives: Other: 8 weeks of Iyengar Yoga |
| 2 | Active comparator | 8 weeks of follow-up, followed by 8 weeks of yoga Receives: Other: 8 weeks of Iyengar Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Pain
Measured: Pre; Post; Weekly
Secondary outcomes (1)
Yoga Attendance
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2008
- Study completionDec 2009
Why it stopped: Enrollment proceeded too slowly to conduct study as RCT.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin, Santosh Yoga LLC
- Responsible party
- Principal investigator, Keri Hainsworth, Medical College of Wisconsin
- Investigators
- Keri R Hainsworth, Ph.D., Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726843
- Sponsor's protocol ID
- 85067-3
- Status last verified
- Apr 2015
- First submitted
- 30 Jul 2008
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Yoga for the Treatment of Pediatric Headaches
- ClinicalTrials.gov ID
- NCT00726843
- Acronym / sponsor ID
- 85067-3
- Conditions
- Headache
- Keywords
- Headache, Complementary and Alternative Medicine, Pediatric, Yoga
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment proceeded too slowly to conduct study as RCT.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin, Santosh Yoga LLC
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Aug 2008 (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.
This study will examine the feasibility and acceptability of yoga for adolescents seen by a medical practitioner for their headaches. The study will also examine whether yoga decreases anxiety and improves quality of life. We hypothesize that yoga will be both acceptable and feasible with a pediatric population. We also hypothesize that yoga will decrease anxiety and improve quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: 8 weeks of Iyengar Yoga8 weeks of Yoga, followed by 8 weeks of follow-up |
| 2 | Active comparator | Other: 8 weeks of Iyengar Yoga8 weeks of follow-up, followed by 8 weeks of yoga |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 13-17 years
- patient seen in the headache clinic at Children's Hospital of Wisconsin
Key exclusion criteria (1 listed)
- neck, spinal, or back injuries
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 |
|---|---|---|
| 8 weeks of Iyengar YogaParticipants will attend 8 weekly, 75 min. yoga sessions, followed by 8 weeks of follow-up (will provide headache frequency/intensity) | Other | 1 |
| 8 weeks of Iyengar YogaParticipants will provide headache frequency/intensity for 8 weeks, followed by 8 weekly, 75 min. yoga sessions | Other | 2 |
Primary outcome
Headache Pain
Time frame: Pre; Post; Weekly
1 secondary outcome
Yoga Attendance
Time frame: weekly
Results and safety
The study was stopped early (reason given: Enrollment proceeded too slowly to conduct study as RCT.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
Related trials for Headache
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
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.
Keri R Hainsworth, Ph.D. principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8 weeks of Iyengar Yoga in people with Headache, run by Medical College of Wisconsin at 1 site in United States.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Enrollment proceeded too slowly to conduct study as RCT.). Results are not available in the source record.
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?
Headache Pain (time frame: Pre; Post; Weekly). 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 7 Apr 2015.