Clinical trial NCT03577548: Influence of Main Psychological and Social Factors on Primary Headaches
Official title: Influence of Main Psychological and Social Factors on Primary Headaches
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Headache, Migraine
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects are suffering from primary headache and come for come for a specialized consultation in the Neurology department of Besançon University Hospital

Brief summary: This study aims to describe the psychological and social characteristics of patients suffering from primary headache and monitored in Neurology department of Besançon University Hospital

Detailed description: The aim of our study is to describe the psychological patterns in a population of patients suffering of episodic migraine or chronic migraine with and without medication overuse and the level of disability.

Data about migraine characteristics will be obtained using a standardized questionnaire.

Socio-demographic data will be obtained for all patients including gender, age, educational level and professional status.

A booklet of 10 self-administered questionnaires will permit to measure psychological factors such as depression, anxiety, alexithymia...

Eligibility criteria: Inclusion Criteria:

* Patients from 25 to 60 ans y.o suffering from primary headache and monitored in the Neurology department of Besançon University Hospital

Exclusion Criteria:

* Patients with former or current psychic troubles

Primary outcomes:
measure: Descriptive analysis of socio-demographic questionnaire
timeFrame: Day 1
measure: Descriptive analysis of Short Form 36 (SF 36) Health Survey
timeFrame: Day 1
measure: Descriptive analysis of General Health Questionnaire 12
timeFrame: Day 1
measure: Descriptive analysis of Cungi test
timeFrame: Day 1
measure: Descriptive analysis of State-Trait Anxiety Inventory Y-A
timeFrame: Day 1
measure: Descriptive analysis of State-Trait Anxiety Inventory Y-B
timeFrame: Day 1
measure: Descriptive analysis of Beck Depression Inventory
timeFrame: Day 1
measure: Descriptive analysis of Social Support Questionnaire 6
timeFrame: Day 1
measure: Descriptive analysis of Toronto Alexithymia Scale 20
timeFrame: Day 1
measure: Descriptive analysis of Bartholomew Relationship Scales Questionnaire
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
citation: Belot RA, Bouteloup M, Bonnet M, Parmentier AL, Magnin E, Mauny F, Vuillier F. Evaluation of Attachment Style and Social Support in Patients With Severe Migraine. Applications in Doctor-Patient Relationships and Treatment Adherence. Front Neurol. 2021 Jul 12;12:706639. doi: 10.3389/fneur.2021.706639. eCollection 2021.
citation: Bouteloup M, Belot RA, Noiret N, Sylvestre G, Bertoux M, Magnin E, Vuillier F. Social and emotional cognition in patients with severe migraine consulting in a tertiary headache center: A preliminary study. Rev Neurol (Paris). 2021 Oct;177(8):995-1000. doi: 10.1016/j.neurol.2020.09.013. Epub 2021 Jan 13.