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Clinical Trials/NCT03577548
NCT03577548
Unknown
N/A

Influence of Main Psychological and Social Factors on Primary Headaches

Centre Hospitalier Universitaire de Besancon1 site in 1 country100 target enrollmentMay 2, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Headache, Migraine
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
100
Locations
1
Primary Endpoint
Descriptive analysis of State-Trait Anxiety Inventory Y-A
Last Updated
7 years ago

Overview

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...

Registry
clinicaltrials.gov
Start Date
May 2, 2016
End Date
August 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Descriptive analysis of State-Trait Anxiety Inventory Y-A

Time Frame: Day 1

Composite 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-B

Time Frame: Day 1

Composite 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 Social Support Questionnaire 6

Time Frame: Day 1

Composite 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 socio-demographic questionnaire

Time Frame: Day 1

Composite 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 Survey

Time Frame: Day 1

Composite 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 Beck Depression Inventory

Time Frame: Day 1

Composite 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 Toronto Alexithymia Scale 20

Time Frame: Day 1

Composite 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 Questionnaire

Time Frame: Day 1

Composite 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.

Descriptive analysis of General Health Questionnaire 12

Time Frame: Day 1

Composite 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 test

Time Frame: Day 1

Composite 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.

Study Sites (1)

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