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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:
Collaborators:
Children's Hospital and Health System Foundation, Wisconsin
Santosh Yoga LLC
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00726843
First received: July 30, 2008
Last updated: September 3, 2010
Last verified: September 2010
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Yoga for the Treatment of Pediatric Headaches

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Headache
U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Headache Pain [ Time Frame: Pre; Post; Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Yoga Attendance [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: July 2008
Study Completion Date: December 2009
Estimated 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

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Keri R. Hainsworth, PhD, Research Psychologist, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00726843     History of Changes
Other Study ID Numbers: 85067-3
Study First Received: July 30, 2008
Last Updated: September 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013