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

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ClinicalTrials.gov Identifier: NCT00897780
Recruitment Status : Unknown
Verified May 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : May 12, 2009
Last Update Posted : May 12, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Chronic Headache Behavioral: Biofeedback with virtual reality

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : September 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Behavioral: Biofeedback with virtual reality
    Participant will use biofeedback technique in combination with virtual reality technique
    Other Names:
    • VR
    • Biofeedback

Outcome Measures

Primary Outcome Measures :
  1. Improvement in headache frequency and pain degree among participants [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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 Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 12, 2009
Last Verified: May 2009

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

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