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Evaluation of Yoga for the Treatment of Pediatric Headaches

This study has been terminated.
(Enrollment proceeded too slowly to conduct study as RCT.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00726843
First Posted: August 1, 2008
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Children's Hospital and Health System Foundation, Wisconsin
Santosh Yoga LLC
Information provided by (Responsible Party):
Keri Hainsworth, Medical College of Wisconsin
  Purpose
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.

Condition Intervention
Headache Other: 8 weeks of Iyengar Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Yoga for the Treatment of Pediatric Headaches

Resource links provided by NLM:


Further study details as provided by Keri Hainsworth, Medical College of Wisconsin:

Primary Outcome Measures:
  • Headache Pain [ Time Frame: Pre; Post; Weekly ]

Secondary Outcome Measures:
  • Yoga Attendance [ Time Frame: weekly ]

Enrollment: 7
Study Start Date: July 2008
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
8 weeks of Yoga, followed by 8 weeks of follow-up
Other: 8 weeks of Iyengar Yoga
Participants will attend 8 weekly, 75 min. yoga sessions, followed by 8 weeks of follow-up (will provide headache frequency/intensity)
Active Comparator: 2
8 weeks of follow-up, followed by 8 weeks of yoga
Other: 8 weeks of Iyengar Yoga
Participants will provide headache frequency/intensity for 8 weeks, followed by 8 weekly, 75 min. yoga sessions

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 13-17 years
  • patient seen in the headache clinic at Children's Hospital of Wisconsin

Exclusion Criteria:

  • neck, spinal, or back injuries
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726843


Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Santosh Yoga LLC
Investigators
Principal Investigator: Keri R Hainsworth, Ph.D. Medical College of Wisconsin
  More Information

Responsible Party: Keri Hainsworth, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00726843     History of Changes
Other Study ID Numbers: 85067-3
First Submitted: July 30, 2008
First Posted: August 1, 2008
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Keri Hainsworth, Medical College of Wisconsin:
Headache
Complementary and Alternative Medicine
Pediatric
Yoga

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms