- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04083131
Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere, France (DysM et SOC)
Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere: Cross-sectional Observational Study
Study Overview
Status
Conditions
Detailed Description
Primary dysmenorrhea affects more than 60% of adolescent girls. Menstrual pain increases absenteeism and lowers self-esteem and academic performance. Moreover, dysmenorrheal women suffer more depression and anxiety.
Sense of coherence (SOC) is composed of three items:
- comprehensibility: what the person understands about his illness
- manageability: what the person does to cope
- meaningfulness: what the disease means to the person. A high SOC score is related to good mental and physical health. The aim of this study will be to determine if there is a relationship between primary dysmenorrhea and the sense of coherence.
A self-questionnaire composed of the SOC-13 and a scale evaluating dysmenorrhea will be proposed in the voluntary high schools of Finistère (France) to the girls of the classes chosen at random.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brest, France, 29200
- Lycée de l'Harteloire
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Douarnenez, France, 29100
- Lycée Jean-Marie Le Bris
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Landerneau, France, 29800
- Lycée de l'Elorn
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Landivisiau, France, 29400
- Lycée du Léon
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Quimper, France, 29000
- Lycée Brizeux
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Quimperlé, France, 29391
- Lycée Roz Glas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- student in high schools
- aged 14 and 19 years
- with menstrual cycle
Exclusion Criteria:
- Illiteracy
- student and parents opposition
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence / absence of dysmenorrhea
Time Frame: Inclusion - Day 0
|
Presence / absence of dysmenorrhea objectified by Visual Analogue Scale (EVA) from 0 to 10 indicating the average pain over the last 3 cycles (if greater than 3 without treatment = primary dysmenorrhea)
|
Inclusion - Day 0
|
Sense of coherence
Time Frame: Inclusion - Day 0
|
Sense of coherence measured by the self-administered French SOC-13 questionnaire (Likert scale).
|
Inclusion - Day 0
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DysM et SOC (29BRC19.0112)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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