Clinical Trials Directory

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UnknownNCT00897780

Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Hadassah Medical Organization · Academic / Other
Sex
All
Age
9 Years – 18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBiofeedback with virtual realityParticipant will use biofeedback technique in combination with virtual reality technique

Timeline

Start date
2009-09-01
Primary completion
2010-09-01
Completion
2010-12-01
First posted
2009-05-12
Last updated
2009-05-12

Source: ClinicalTrials.gov record NCT00897780. Inclusion in this directory is not an endorsement.