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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
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Headache focused on measuring Headache, Pediatric, Virtual Reality, Biofeedback

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 10, 2009
    Last Updated
    May 11, 2009
    Sponsor
    Hadassah Medical Organization
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    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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