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Comparing Sensory Modulation, Anxiety and Quality of Life Between Children With Primary Headaches and Healthy Peers

NCT04284501 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-02-25

No results posted yet for this study

Summary

Study hypotheses:

1. Children with headaches will show significantly higher sensory reactivity, higher anxiety level and lower quality of life that health controls.
2. Among children with headaches, sensory reactivity will significantly correlate with higher anxiety level and lower quality of life.
3. Among children with headaches quality of life will be predicted by sensory reactivity and anxiety level.

Study significance:

This is one of the first studies to explore the role of sensory reactivity and its relation to the psychological (anxiety) aspects among children and youth with headaches.

Moreover, by using an elaborated point of view this study also measures the interaction between these factors and the child's quality of life.

Referring to this interaction is critical for the intervention process in the meaning of:

(a) helping determine whether pediatric headaches is best conceptualized as a CNS disorder, an emotional disorder, or some hybrid (b) increasing physicians' recognition of headaches pathogenesis and related outcomes, encouraging physicians to refer in the intake and intervention to both children and parents and when needed - to consider mental health services for child/parents. (c) to illuminate the physiological/psychological factors that have the most significant impact on QOL of children with headaches.

Methods:

Participants:

The sample will include 60 children aged 8-18 years. The study group will include 30 children diagnosed with Primary headache - Migraine or TTH. They will be recruited from the pediatric neurological clinic in Bnai-Zion Health Center.

The control group will include 30 children from the community with typical development and no history of chronic headaches or another chronic disease, no ADHD or learning disabilities, matched by age, gender and socio-economic status to the study group.

Inclusion criteria for the study group:

Children with Primary headaches diagnosed as Migraine or TTH between 8-18 years of age.

Exclusion criteria for the sample group Evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject's symptoms.

Conditions

Interventions

BEHAVIORAL

Non

questionnaire

Sponsors & Collaborators

  • Bnai Zion Medical Center

    lead OTHER_GOV

Principal Investigators

  • Jacob Genizi, MD · Bnai Zion Medical Center

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-01
Primary Completion
2021-01-01
Completion
2021-01-01

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04284501 on ClinicalTrials.gov