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Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache (VR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00897780
First received: May 10, 2009
Last updated: May 11, 2009
Last verified: May 2009
  Purpose

The objective of the study is to examine the effect of combined treatments (biofeedback with virtual reality) for pediatric chronic headache.


Condition Intervention
Chronic Headache
Behavioral: Biofeedback with virtual reality

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Improvement in headache frequency and pain degree among participants [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Biofeedback with virtual reality
    Participant will use biofeedback technique in combination with virtual reality technique
    Other Names:
    • VR
    • Biofeedback
Detailed Description:

Chronic headache is a common symptom in children. Pharmacologic treatment has only a limited productivity and several known adverse reactions. Despite the frequency and chronicity of pediatric headache, validated treatment paradigms are currently inadequate.

Biofeedback is a medical treatment in which physiologic markers like heart rate, breathing rate, EMG, EEG, or electrodermal activity are measured and displayed back to the patient. The patient can then attempt to modulate physiology to achieve a certain feedback goal,such as slowing heart or breath rate, or relaxing certain muscles. Numerous psychophysiologic studies have been conducted that examine the effect of biofeedback alone on physiology as well as various clinical conditions. Clinical trials for chronic headaches have found that biofeedback was more effective in the treatment of headache when compared to pure drug therapy.

A number of recent distraction interventions for acute pain in children and adolescents have employed virtual reality technology in conjunction with either a passive distraction stimulus, such as a movie, or an interactive distraction activity, such as a computer game. However, the actual benefit of VR technology over and above the benefits of the distracting stimulus that is experienced through the VR equipment has not been adequately tested in children.

The objective of this study is to combine virtual reality with biofeedback in order to increase the effectivity of both techniques in decreasing chronic headache frequency and pain degree in the pediatric population.

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 9-18 years old children suffering from chronic headache diagnosed by pediatric neurologist
  • Exclusion of Other disorders causing chronic headache

Exclusion Criteria:

  • Children younger than 9 years or olde than 18.
  • Children who do not fulfill headache criteria as described in the International Headache Society
  • Children who were not examined by a certified pediatric neurologist
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Itai Berger, MD, HAdassah-Hebrew University Medical Center
ClinicalTrials.gov Identifier: NCT00897780     History of Changes
Other Study ID Numbers: HMO-0445-08
Study First Received: May 10, 2009
Last Updated: May 11, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Headache
Pediatric
Virtual Reality
Biofeedback

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

ClinicalTrials.gov processed this record on November 24, 2014