Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache

Chronic Headache Clinical Trial

— VR  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00897780
• Other study ID #: HMO-0445-08
• Status: Not yet recruiting
• Phase: N/A
• First received: May 10, 2009
• Last updated: May 11, 2009
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Headache
• Headache

Intervention

Behavioral:
• Biofeedback with virtual reality
Participant will use biofeedback technique in combination with virtual reality technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in headache frequency and pain degree among participants		6 weeks	No