Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache (VR)
Recruitment status was Not yet recruiting
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Purpose
The objective of the study is to examine the effect of combined treatments (biofeedback with virtual reality) for pediatric chronic headache.
| Condition | Intervention |
|---|---|
|
Chronic Headache |
Behavioral: Biofeedback with virtual reality |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
- Improvement in headache frequency and pain degree among participants [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
-
Behavioral: Biofeedback with virtual reality
- VR
- Biofeedback
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.
Eligibility| Ages Eligible for Study: | 9 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Itai Berger, MD, HAdassah-Hebrew University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00897780 History of Changes |
| Other Study ID Numbers: | HMO-0445-08 |
| Study First Received: | May 10, 2009 |
| Last Updated: | May 11, 2009 |
| Health Authority: | Israel: Ministry of Health |
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 |
ClinicalTrials.gov processed this record on June 17, 2013