Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere, France (DysM et SOC)

January 6, 2020 updated by: University Hospital, Brest

Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere: Cross-sectional Observational Study

This study evaluates the relation between sens of coherence and primary dysmenorrhea. Aself-questionnaire is completed by a sample of girls aged between 14 and 19, schooled in Finistère (France).

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brest, France, 29200
        • Lycée de l'Harteloire
      • Douarnenez, France, 29100
        • Lycée Jean-Marie Le Bris
      • Landerneau, France, 29800
        • Lycée de l'Elorn
      • Landivisiau, France, 29400
        • Lycée du Léon
      • Quimper, France, 29000
        • Lycée Brizeux
      • Quimperlé, France, 29391
        • Lycée Roz Glas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

High school girls in Finistère

Description

Inclusion Criteria:

  • student in high schools
  • aged 14 and 19 years
  • with menstrual cycle

Exclusion Criteria:

  • Illiteracy
  • student and parents opposition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2019

Primary Completion (Actual)

November 5, 2019

Study Completion (Actual)

November 5, 2019

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning 6 months and ending three years following the publication

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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