Chronic Headache Clinical Trial
The objective of the study is to examine the effect of combined treatments (biofeedback with virtual reality) for pediatric chronic headache.
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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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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