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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
ClinicalTrials.gov Identifier:
First Posted: May 12, 2009
Last Update Posted: May 12, 2009
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.
Information provided by:
Hadassah Medical Organization
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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.


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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
No Contacts or Locations Provided
  More Information

Responsible Party: Itai Berger, MD, HAdassah-Hebrew University Medical Center
ClinicalTrials.gov Identifier: NCT00897780     History of Changes
Other Study ID Numbers: HMO-0445-08
First Submitted: May 10, 2009
First Posted: May 12, 2009
Last Update Posted: May 12, 2009
Last Verified: May 2009

Keywords provided by Hadassah Medical Organization:
Virtual Reality

Additional relevant MeSH terms:
Headache Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases