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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Headache||Behavioral: Biofeedback with virtual reality||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
Behavioral: Biofeedback with virtual reality
- Improvement in headache frequency and pain degree among participants [ Time Frame: 6 weeks ]