Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere, France

Primary Dysmenorrhea Clinical Trial

— DysM et SOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083131
• Other study ID #: DysM et SOC (29BRC19.0112)
• Status: Completed
• Start date: September 25, 2019
• Est. completion date: November 5, 2019

Study information

• Verified date: January 2020
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: November 5, 2019
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

Inclusion Criteria:

• student in high schools

• aged 14 and 19 years

• with menstrual cycle

Exclusion Criteria:

• Illiteracy

• student and parents opposition

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Locations

Country	Name	City	State
France	Lycée de l'Harteloire	Brest
France	Lycée Jean-Marie Le Bris	Douarnenez
France	Lycée de l'Elorn	Landerneau
France	Lycée du Léon	Landivisiau
France	Lycée Brizeux	Quimper
France	Lycée Roz Glas	Quimperlé

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence / absence of dysmenorrhea	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
Primary	Sense of coherence	Sense of coherence measured by the self-administered French SOC-13 questionnaire (Likert scale).	Inclusion - Day 0