Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache (VR)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2009 by Hadassah Medical Organization.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00897780

First received: May 10, 2009

Last updated: May 11, 2009

Last verified: May 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	May 10, 2009
Last Updated Date	May 11, 2009
Start Date ^ICMJE	September 2009
Estimated Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 11, 2009)	Improvement in headache frequency and pain degree among participants [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00897780 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache
Official Title ^ICMJE
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.
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Chronic Headache
Intervention ^ICMJE	Behavioral: Biofeedback with virtual reality Participant will use biofeedback technique in combination with virtual reality technique Other Names: VR Biofeedback
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	December 2010
Estimated Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	9 Years to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT00897780
Other Study ID Numbers ^ICMJE	HMO-0445-08
Has Data Monitoring Committee	Yes
Responsible Party	Itai Berger, MD, HAdassah-Hebrew University Medical Center
Study Sponsor ^ICMJE	Hadassah Medical Organization
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Hadassah Medical Organization
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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