Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache (VR)
Primary Purpose
Chronic Headache
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biofeedback with virtual reality
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Headache focused on measuring Headache, Pediatric, Virtual Reality, Biofeedback
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Improvement in headache frequency and pain degree among participants
Secondary Outcome Measures
Full Information
NCT ID
NCT00897780
First Posted
May 10, 2009
Last Updated
May 11, 2009
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00897780
Brief Title
Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache
Acronym
VR
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Headache
Keywords
Headache, Pediatric, Virtual Reality, Biofeedback
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback with virtual reality
Other Intervention Name(s)
VR, Biofeedback
Intervention Description
Participant will use biofeedback technique in combination with virtual reality technique
Primary Outcome Measure Information:
Title
Improvement in headache frequency and pain degree among participants
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache
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