Adolescent DysmenorrheaDAPsvsNCT04007471
Adolescent Dysmenorrhea : Prevalence, Severity, Experience and Management in the Use of Medication in High School Girls in Ille-et-Vilaine
An observational study of Adolescent Dysmenorrhea, run by Rennes University Hospital at 1 site in France.
Trial summary
Dysmenorrhea or painful menstruation is a common symptom of menses. Dysmenorrhea is defined as a painful, cramping sensation in the lower abdomen or back associated with menstrual periods and is classified into primary and secondary types. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Dysmenorrhea
- What is being tested?
- Anonymous survey
- How many people
- 979 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2019to 17 May 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 15 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Cohort of adolescent girls aged between 15 and 19 years old who go to a private or public highschool in Ille-et-Vilaine A sample of 960 girls were obtained
Who may be able to join
- Adolescent girls aged between 15 and 19 years old
- Menstruating adolescent girls
- Accept participation
- Schooled in one of the 8 randomised public and private high schools in Ille-et-Vilaine
Who cannot join
- Girls under 15 or over 19 years old
- If a girl or their parents didn't want their daughter to participate
- Primary or secondary amenorrhea during more than 6 months in the past year
Trial locations and contacts
1 site in 1 country.
About this study
Dysmenorrhea or painful menstruation is a common symptom of menses. Dysmenorrhea is defined as a painful, cramping sensation in the lower abdomen or back associated with menstrual periods and is classified into primary and secondary types. Primary dysmenorrhea is painful menstrual periods not due to other diseases, and often occurs soon after menarche. Secondary dysmenorrhea is due to an underlying pelvic abnormality, such as endometriosis.
Dysmenorrhea is the most common gynecological complaint. In many studies, the prevalence of primary dysmenorrhea varies between 34 % in 2010 in Egypt, 86.6% in 2002 in Switzerland, and 21% in 1999 in France.
Read more
Nowadays, physiopathology is better understood, which suggests that the investigators have treatments Although dysmenorrhea is a common concern, many women never seek medical advice, even though treatments are easily available and simple.
In fact, despite the high prevalence, dysmenorrhea is undertreated and even disregarded by health professionals, and the girls themselves, who may accept it as a normal part of the menstrual cycle.
The pain occurs just before and/or during menstruation ; it can be mild to severe and is frequently associated with many other symptoms, like nausea, vomiting, headache, diarrhea, tiredness and has many consequences in wellbeing and school. Dysmenorrhea is known to be the first cause of absenteism from school, and appears to have many consequences and a real impact on women's daily activities, which is why it's a public health problem.
Because of the lack of recent studies in France, the aim of this study is to evaluate the prevalence of adolescent dysmenorrhea. The investigators also assessed its severity, how adolescent girls experienced their menses, and how they manage their pain (seeking medical consultation, use of medication).
The investigators used a self-assessment questionnaire in a cohort of high school girls, aged 15 to 19 years old, during April and May of 2019, in 8 private and public high schools in Ille-et-Vilaine.
Read the detailed description
It was an observational, quantitative and prospective study, in a cohort of adolescent girls, to assess the prevalence of adolescent dysmenorrhea through an anonymous self-assessment questionnaire, which took place in 8 randomised public and private high schools in Ille-et-Vilaine, Brittany, France.
Only adolescents aged between 15 and 19 years old who agreed to participate were included. Girls who had experienced primary or secondary amenorrhea for more than 6 months in the past year were excluded.
The target number of participants was 770 adolescents girls aged between 15 and 19 years old.
The main objective was to determine the prevalence of dysmenorrhea within adolescent girls in a sample in France.
The other objectives were to assess the severity, how girls experienced their menses, the consequences on daily living activities or at school, and how they manage their pain.
The severity of dysmenorrhea were assessed with Andersch and Milsom's scale and Numerical Rating Scale (NRS).
First of all, the investigators also obtained the authorization of the Committee of Protection of People of Montpellier University Hospital.
After that, the investigators contacted the high school principals of the 8 high schools which were randomized, and obtained their authorization to organise this study in their schools.
The investigators gave an information to the parents and adolescent girls about ten days before the study. If a girl or their parents didn't want their daughter to participate, they could inform the high school principal or the school nurse. The investigators asked the nurse or the directos of high schools to make a randomisation of the girls.
Then, the investigators gathered them in a classroom, with no boys, to make sure that the girls felt free and confident enough to complete the questionnaire in the most honest way. The investigators gave them the questionnaires, and let them complete it, which took about 15-20 minutes.
The main investigator was present to answer the girls if any questions were not understood.
After completion, the questionnaires were immediately retrieved by the main investigator.
Finally, the investigators briefly communicated what menses are and other symptoms, how to relieve the pain, with or without medication, and in what case the girls must see a doctor. The investigators gave them an advice sheet. The aim was to improve the management of dysmenorrhea and their quality of life by informing adolescent girls of the availability of effective therapy and the need to consult a doctor in some situations.
A sample of 960 adolescents completed the questionnaire, and 19 were excluded. The prevalence of dysmenorrhea will be calculated. Then, the investigators will analyze the sample.
These results will provide a better understanding of dysmenorrhea, its recent prevalence, its severity, its influencing factors and its consequences on daily activities. This study will help to better know the impact of dysmenorrhea, which is frequently underestimated and misunderstood by girls themselves, their parents, their families and their teachers.
In addition, throughout this study, the reasons why adolescent girls may not want to seek medical consultation might be known. The investigators could as general practitionner or gynecologist better explain and advise adolescent girls, offer them relief and better conditions of life, while staying aware of the possibility of secondary dysmenorrhea.
- Conditions
- Adolescent Dysmenorrhea
- Being tested
- Anonymous survey
- Keywords
- Dysmenorrhea, Primary dysmenorrhea, Secondary dysmenorrhea, Pelvic pain, Menstrual pain, Adolescent, Endometriosis
- Medical subject headings
- Dysmenorrhea, Pelvic Pain, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anonymous surveyOther
Anonymous questionnaire to determine the prevalence of dysmenorrhea of adolescent girls, to assess the severity of dysmenorrhea, how girls experience their menses, the consequences on daily living activities or at school, and how they manage their pain.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dysmenorrhea
" During last past year, have you ever experienced pain in your lower abdomen or back associated with menstrual periods ? " " Never " - " Sometimes " - " Always "
Measured: Inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start24 Apr 2019
- Primary completion17 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- 979 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maud BIDET, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007471
- Sponsor's protocol ID
- 35RC19_30017_DAPsvs
- Acronym
- DAPsvs
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Dysmenorrhea : Prevalence, Severity, Experience and Management in the Use of Medication in High School Girls in Ille-et-Vilaine
- ClinicalTrials.gov ID
- NCT04007471
- Acronym / sponsor ID
- DAPsvs / 35RC19_30017_DAPsvs
- Conditions
- Adolescent Dysmenorrhea
- Keywords
- Dysmenorrhea, Primary dysmenorrhea, Secondary dysmenorrhea, Pelvic pain, Menstrual pain, Adolescent, Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 979 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 5 Jul 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.
Dysmenorrhea or painful menstruation is a common symptom of menses. Dysmenorrhea is defined as a painful, cramping sensation in the lower abdomen or back associated with menstrual periods and is classified into primary and secondary types. Primary dysmenorrhea is painful menstrual periods not due to other diseases, and often occurs soon after menarche. Secondary dysmenorrhea is due to an underlying pelvic abnormality, such as endometriosis.
Dysmenorrhea is the most common gynecological complaint. In many studies, the prevalence of primary dysmenorrhea varies between 34 % in 2010 in Egypt, 86.6% in 2002 in Switzerland, and 21% in 1999 in France.
Nowadays, physiopathology is better understood, which suggests that the investigators have treatments Although dysmenorrhea is a common concern, many women never seek medical advice, even though treatments are easily available and simple.
In fact, despite the high prevalence, dysmenorrhea is undertreated and even disregarded by health professionals, and the girls themselves, who may accept it as a normal part of the menstrual cycle.
The pain occurs just before and/or during menstruation ; it can be mild to severe and is frequently associated with many other symptoms, like nausea, vomiting, headache, diarrhea, tiredness and has many consequences in wellbeing and school. Dysmenorrhea is known to be the first cause of absenteism from school, and appears to have many consequences and a real impact on women's daily activities, which is why it's a public health problem.
Because of the lack of recent studies in France, the aim of this study is to evaluate the prevalence of adolescent dysmenorrhea. The investigators also assessed its severity, how adolescent girls experienced their menses, and how they manage their pain (seeking medical consultation, use of medication).
The investigators used a self-assessment questionnaire in a cohort of high school girls, aged 15 to 19 years old, during April and May of 2019, in 8 private and public high schools in Ille-et-Vilaine.
Detailed description
It was an observational, quantitative and prospective study, in a cohort of adolescent girls, to assess the prevalence of adolescent dysmenorrhea through an anonymous self-assessment questionnaire, which took place in 8 randomised public and private high schools in Ille-et-Vilaine, Brittany, France.
Only adolescents aged between 15 and 19 years old who agreed to participate were included. Girls who had experienced primary or secondary amenorrhea for more than 6 months in the past year were excluded.
The target number of participants was 770 adolescents girls aged between 15 and 19 years old.
The main objective was to determine the prevalence of dysmenorrhea within adolescent girls in a sample in France.
The other objectives were to assess the severity, how girls experienced their menses, the consequences on daily living activities or at school, and how they manage their pain.
The severity of dysmenorrhea were assessed with Andersch and Milsom's scale and Numerical Rating Scale (NRS).
First of all, the investigators also obtained the authorization of the Committee of Protection of People of Montpellier University Hospital.
After that, the investigators contacted the high school principals of the 8 high schools which were randomized, and obtained their authorization to organise this study in their schools.
The investigators gave an information to the parents and adolescent girls about ten days before the study. If a girl or their parents didn't want their daughter to participate, they could inform the high school principal or the school nurse. The investigators asked the nurse or the directos of high schools to make a randomisation of the girls.
Then, the investigators gathered them in a classroom, with no boys, to make sure that the girls felt free and confident enough to complete the questionnaire in the most honest way. The investigators gave them the questionnaires, and let them complete it, which took about 15-20 minutes.
The main investigator was present to answer the girls if any questions were not understood.
After completion, the questionnaires were immediately retrieved by the main investigator.
Finally, the investigators briefly communicated what menses are and other symptoms, how to relieve the pain, with or without medication, and in what case the girls must see a doctor. The investigators gave them an advice sheet. The aim was to improve the management of dysmenorrhea and their quality of life by informing adolescent girls of the availability of effective therapy and the need to consult a doctor in some situations.
A sample of 960 adolescents completed the questionnaire, and 19 were excluded. The prevalence of dysmenorrhea will be calculated. Then, the investigators will analyze the sample.
These results will provide a better understanding of dysmenorrhea, its recent prevalence, its severity, its influencing factors and its consequences on daily activities. This study will help to better know the impact of dysmenorrhea, which is frequently underestimated and misunderstood by girls themselves, their parents, their families and their teachers.
In addition, throughout this study, the reasons why adolescent girls may not want to seek medical consultation might be known. The investigators could as general practitionner or gynecologist better explain and advise adolescent girls, offer them relief and better conditions of life, while staying aware of the possibility of secondary dysmenorrhea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Cohort of adolescent girls aged between 15 and 19 years old who go to a private or public highschool in Ille-et-Vilaine A sample of 960 girls were obtained
Key inclusion criteria (4 listed)
- Adolescent girls aged between 15 and 19 years old
- Menstruating adolescent girls
- Accept participation
- Schooled in one of the 8 randomised public and private high schools in Ille-et-Vilaine
Key exclusion criteria (3 listed)
- Girls under 15 or over 19 years old
- If a girl or their parents didn't want their daughter to participate
- Primary or secondary amenorrhea during more than 6 months in the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anonymous surveyAnonymous questionnaire to determine the prevalence of dysmenorrhea of adolescent girls, to assess the severity of dysmenorrhea, how girls experience their menses, the consequences on daily living activities or at school, and how they manage their pain. | Other | – |
Primary outcome
Prevalence of dysmenorrhea
Time frame: Inclusion day
" During last past year, have you ever experienced pain in your lower abdomen or back associated with menstrual periods ? " " Never " - " Sometimes " - " Always "
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 13 Apr 2023.
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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.
Maud BIDET, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Dysmenorrhea, run by Rennes University Hospital at 1 site 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 4 inclusion and 3 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prevalence of dysmenorrhea (time frame: Inclusion day). 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 13 Apr 2023.