Comparing Sensory Modulation, Anxiety and Quality of Life Between Children With Primary Headaches and Healthy Peers
The Relationship Between Pain Catastrophizing Level, Extreme Sensory Processing Patterns and Headache Severity Among Adolescents With Migraine
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 16, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedFebruary 25, 2020
February 1, 2020
6.4 years
February 16, 2020
February 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Extreme sensory processing patterns in the Short Sensory Profile questionnaire
The Short Sensory Profile (SSP)(26)- This parent report evaluated children's sensory processing patterns, as expressed in all sensory modality and in daily living situations (for example: "will only eat certain tastes"; "reacts emotionally or aggressively to touch"). The Parent scores their childs' response to sensory stimuli on a 5 point Likert scale, where 1 represents "always" and 5 "never". Seven subtests are scored: tactile sensitivity, taste/smell sensitivity, sensitivity to movement, visual/auditory sensitivity and auditory filtering, as well as a total score which ranges between 38 to 190. Higher scores (155-190) reflect typical/normal performance. A score between 142-154 reflects a probable difference in performance while a score between 38-141 reflects a definite difference in performance
10years
Study Arms (2)
Study
children with Migraine headache
Control
Healthy children
Interventions
Eligibility Criteria
children
You may qualify if:
- Children with Primary headaches diagnosed as Migraine or TTH between 8-18 years of age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bani Zion
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Genizi, MD
Bnai Zion Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Pediatric Neurology Unit
Study Record Dates
First Submitted
February 16, 2020
First Posted
February 25, 2020
Study Start
August 1, 2014
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
February 25, 2020
Record last verified: 2020-02