Primary DysmenorrheaDysM et SOCNCT04083131
Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere, France
An observational study of Primary Dysmenorrhea, run by University Hospital, Brest at 6 sites in France.
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). Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- How many people
- 255 participants
- Where
- 6 sitesFrance
- Study dates
- 25 Sep 2019to 5 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: High school girls in Finistère
Who may be able to join
- student in high schools
- aged 14 and 19 years
- with menstrual cycle
Who cannot join
- Illiteracy
- student and parents opposition
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Lycée de l'Harteloire
Brest, 29200
Lycée Jean-Marie Le Bris
Douarnenez, 29100
Lycée de l'Elorn
Landerneau, 29800
Lycée du Léon
Landivisiau, 29400
Lycée Brizeux
Quimper, 29000
Lycée Roz Glas
Quimperlé, 29391
About this study
Official title: 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).
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Keywords
- Sens of coherence, Primary dysmenorrhea, Salutogenesis, Teenagers
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Inclusion - Day 0
Sense of coherence
Sense of coherence measured by the self-administered French SOC-13 questionnaire (Likert scale).
Measured: Inclusion - Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start25 Sep 2019
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083131
- Sponsor's protocol ID
- DysM et SOC (29BRC19.0112)
- Acronym
- DysM et SOC
- Status last verified
- Jan 2020
- First submitted
- 6 Sep 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere: Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT04083131
- Acronym / sponsor ID
- DysM et SOC / DysM et SOC (29BRC19.0112)
- Conditions
- Primary Dysmenorrhea
- Keywords
- Sens of coherence, Primary dysmenorrhea, Salutogenesis, Teenagers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- High school girls in Finistère
Key inclusion criteria (3 listed)
- student in high schools
- aged 14 and 19 years
- with menstrual cycle
Key exclusion criteria (2 listed)
- Illiteracy
- student and parents opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Sense of coherence
Time frame: Inclusion - Day 0
Sense of coherence measured by the self-administered French SOC-13 questionnaire (Likert scale).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dysmenorrhea, run by University Hospital, Brest at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence / absence of dysmenorrhea (time frame: Inclusion - Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.