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Influence of Main Psychological and Social Factors on Primary Headaches

Influence of Main Psychological and Social Factors on Primary Headaches

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03577548
Acronym
CEPHAPSY
Enrollment
100
Registered
2018-07-05
Start date
2016-05-02
Completion date
2018-08-31
Last updated
2018-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Migraine

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...

Interventions

OTHERAuto- questionnaires

10 auto-questionnaires are submitted to the patient during his/her consultation (which is part of the standard care).

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Descriptive analysis of socio-demographic questionnaireDay 1Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class.
Descriptive analysis of Short Form 36 (SF 36) Health SurveyDay 1Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class. This questionnaire asseses quality of life.
Descriptive analysis of General Health Questionnaire 12Day 1Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class. Ranges for this questionnaire: 0 - 1 : no psychological distress / 2 - 3 : psychological problems / 4 - 48 : suspicion of mental illness.
Descriptive analysis of Cungi testDay 1Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class. Ranges for this questionnaire: 12 - 19 : very low level of stress / 20 - 30 : low level of stress / 31 - 45 : high level of stress / \> 45 : very high level of stress.
Descriptive analysis of State-Trait Anxiety Inventory Y-ADay 1Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class. Ranges for this questionnaire (current anxiety): \< 36 : very low / 36 à 45 : low / 46 à 55 : medium / 56 à 65 : high / \> 65 : very high.
Descriptive analysis of State-Trait Anxiety Inventory Y-BDay 1Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class. Ranges for this questionnaire (general anxiety): \< 36 : very low / 36 à 45 : low / 46 à 55 : medium / 56 à 65 : high / \> 65 : very high.
Descriptive analysis of Beck Depression InventoryDay 1Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class. Ranges for this questionnaire: 0 - 4 : no depression / 5 - 7 : mild depression / 8 - 15 : moderate depression / \> 15 : severe depression.
Descriptive analysis of Social Support Questionnaire 6Day 1Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class. This questionnaire assesses satisfaction upon social support.
Descriptive analysis of Toronto Alexithymia Scale 20Day 1Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class. Three levels for alexythimia: \< 44 : non-alexithymia / 44 à 55 : possible alexithymia / \> 55 : alexithymia.
Descriptive analysis of Bartholomew Relationship Scales QuestionnaireDay 1Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class. Four levels for this questionnaire: Secure, Preoccupied, Dismissing and Fearful.

Countries

France

Contacts

Primary ContactRose-Angélique BELOT
rose-angelique.belot@univ-fcomte.fr
Backup ContactMargaux BOUTELOUP
margaux.bouteloup@live.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026