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Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00897780
Acronym
VR
Enrollment
30
Registered
2009-05-12
Start date
2009-09-30
Completion date
2010-12-31
Last updated
2009-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Headache

Keywords

Headache, Pediatric, Virtual Reality, Biofeedback

Brief 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.

Interventions

BEHAVIORALBiofeedback with virtual reality

Participant will use biofeedback technique in combination with virtual reality technique

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frame
Improvement in headache frequency and pain degree among participants6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026