NCT00897780

Brief Summary

The objective of the study is to examine the effect of combined treatments (biofeedback with virtual reality) for pediatric chronic headache.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 12, 2009

Status Verified

May 1, 2009

Enrollment Period

1 year

First QC Date

May 10, 2009

Last Update Submit

May 11, 2009

Conditions

Chronic Headache

Keywords

HeadachePediatricVirtual RealityBiofeedback

Outcome Measures

Primary Outcomes (1)

  • Improvement in headache frequency and pain degree among participants

    6 weeks

Interventions

Biofeedback with virtual realityBEHAVIORAL

Participant will use biofeedback technique in combination with virtual reality technique

Also known as: VR, Biofeedback

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old children suffering from chronic headache diagnosed by pediatric neurologist

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Headache DisordersHeadache

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2009

First Posted

May 12, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

May 12, 2009

Record last verified: 2009-05