DysmenorrheaDEMETERNCT05414825
Dysmenorrhea Exploration in Teenagers, Their Parents and Caregivers
An observational study of Dysmenorrhea, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Teenagers experimenting severe dysmenorrhea also face age-specific challenges, particularly impacting their self-confidence, self-esteem, and relations. On one hand, the study team will conduct focus group interviews to better understand the experience of teenagers and their parents consulting pediatric services for… Read more about this study
- Who is it for?
- Ages 11 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- focus group interview
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2022to 13 Sep 2022
- 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 11 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 3 types of population with a link to severe dysmenorrhea (whether through their own story, or child, or profession described throught eligibility criteria above)
Who may be able to join
- For " teenage" groups:
- adolescents between 11 and 17 years old
- consulting for severe dysmenorrhea (whether through pediatric gynecology, pain management or gastric consultation)
- For "parents" groups:
- o Parent (mother or father) of an adolescent patient consulting for severe dysmenorrhea
- For "medical staff" groups:
- Member of a consultation receiving adolescent patients with severe dysmenorrhea
- All type of professionals (nurses, psychologist, doctors…)
Who cannot join
- For " teenage" groups:
- suffering from an identified chronical disease
- identified psychiatric condition
- For "parents" groups:
- o Parents whose adolescent opposes their participation in this study
- For "medical staff" groups:
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Descriptive Study Regarding the Impact of Severe Dysmenorrhea on Teenagers, Their Parents and Caregivers Receiving Those Patients
Teenagers experimenting severe dysmenorrhea also face age-specific challenges, particularly impacting their self-confidence, self-esteem, and relations. On one hand, the study team will conduct focus group interviews to better understand the experience of teenagers and their parents consulting pediatric services for severe dysmenorrhea. On the other hand, they will conduct focus group interviews with caregivers from services that usually encounter such patients (gastrologic, gynecologic and pain services). This, allowing to later propose specific tools and healthcare organization to evaluate and accompany teenagers suffering from severe dysmenorrhea.
Read the detailed description
Endometriosis is a complex disease that remains underdiagnosed (7 to 9 years delay), and incorrectly treated. While endometriosis was at first considered as a condition affecting adult women, since the early 2000s, literature has described more and more cases of adolescent patients, with frequently atypical presentations. Indirect prevalence estimates ranging from 25% to 100% in adolescents' girls with pelvic pain. Moreover, Arruda et al. indicate that adolescents girls arrive after a delay in diagnosis which has a significant impact on the progression of the disease and on their confidence in the medical listening and understanding abilities. However, the pain induced by dysmenorrhea has a profound impact on everyday life of and are frequently responsible for school missing as shown in the RESENDO survey.
By conducting a qualitative analysis based on focus groups, the main objective of the study is to describe as faithfully and extensively as possible the experience of teenage patients and their parents consulting for severe dysmenorrhea, and delineate factors potentially improving or hindering care engagement.
The study utilizes a qualitative method as a tool to have a better understanding of this population, a population increasing in pediatric gynecology services or pain management consultations. Gathering their words, their views on their symptoms and its repercussions, and their main issues, will enable to build a relationship of trust with caregivers, better address the broad problematic, and identify risk factors.
- Conditions
- Dysmenorrhea
- Being tested
- focus group interview
- Keywords
- Endometriosis, severe dysmenorrhea, pain, teenagers, pediatric, qualitative research, focus group, patient care management
- Medical subject headings
- Dysmenorrhea, Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focus group interviewOther
Group interview gathering words, views, symptoms and its repercussions, and main issues of the subjects regarding severe dysmenorrhea
| Study group | Role | What they receive |
|---|---|---|
| 11 to 14 years old teenagers | Semi-structured discussion group with only young teenagers, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on the feelings of the young teenagers suffering from severe dysmenorrhea. Receives: Other: focus group interview | |
| 15 to 17 years old teenagers | Semi-structured discussion group with older teenagers, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on the feelings of these patients suffering from severe dysmenorrhea. Receives: Other: focus group interview | |
| 11 to 14 years old teenagers' parents | Semi-structured discussion group with parents of young teenagers, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on the feelings of the parents on the care and feelings of their child suffering from severe dysmenorrhea. Receives: Other: focus group interview | |
| 15 to 17 years old teenagers' parents | Semi-structured discussion group with parents of older teenagers, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on the feelings of the parents on the care and feelings of their child suffering from severe dysmenorrhea. Receives: Other: focus group interview | |
| caregivers | Semi-structured discussion group with medical staff in services potentially treating dysmenorrhea patients, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on the feelings of the caregivers on the care and feelings of the patients suffering from severe dysmenorrhea. Receives: Other: focus group interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
main themes emerging from focus group
qualitative outcome : identifying the main verbatim used during the focus group
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start29 Aug 2022
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale
- Responsible party
- Sponsor
- Investigators
- Agnès SUC, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414825
- Sponsor's protocol ID
- RC31/22/0120
- Acronym
- DEMETER
- Status last verified
- Nov 2022
- First submitted
- 25 Apr 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Descriptive Study Regarding the Impact of Severe Dysmenorrhea on Teenagers, Their Parents and Caregivers Receiving Those Patients
- ClinicalTrials.gov ID
- NCT05414825
- Acronym / sponsor ID
- DEMETER / RC31/22/0120
- Conditions
- Dysmenorrhea
- Keywords
- Endometriosis, severe dysmenorrhea, pain, teenagers, pediatric, qualitative research, focus group, patient care management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 10 Jun 2022 (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.
Teenagers experimenting severe dysmenorrhea also face age-specific challenges, particularly impacting their self-confidence, self-esteem, and relations. On one hand, the study team will conduct focus group interviews to better understand the experience of teenagers and their parents consulting pediatric services for severe dysmenorrhea. On the other hand, they will conduct focus group interviews with caregivers from services that usually encounter such patients (gastrologic, gynecologic and pain services). This, allowing to later propose specific tools and healthcare organization to evaluate and accompany teenagers suffering from severe dysmenorrhea.
Detailed description
Endometriosis is a complex disease that remains underdiagnosed (7 to 9 years delay), and incorrectly treated. While endometriosis was at first considered as a condition affecting adult women, since the early 2000s, literature has described more and more cases of adolescent patients, with frequently atypical presentations. Indirect prevalence estimates ranging from 25% to 100% in adolescents' girls with pelvic pain. Moreover, Arruda et al. indicate that adolescents girls arrive after a delay in diagnosis which has a significant impact on the progression of the disease and on their confidence in the medical listening and understanding abilities. However, the pain induced by dysmenorrhea has a profound impact on everyday life of and are frequently responsible for school missing as shown in the RESENDO survey.
By conducting a qualitative analysis based on focus groups, the main objective of the study is to describe as faithfully and extensively as possible the experience of teenage patients and their parents consulting for severe dysmenorrhea, and delineate factors potentially improving or hindering care engagement.
The study utilizes a qualitative method as a tool to have a better understanding of this population, a population increasing in pediatric gynecology services or pain management consultations. Gathering their words, their views on their symptoms and its repercussions, and their main issues, will enable to build a relationship of trust with caregivers, better address the broad problematic, and identify risk factors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 11 to 14 years old teenagers | – | Other: focus group interviewSemi-structured discussion group with only young teenagers, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on the feelings of the young teenagers suffering from severe dysmenorrhea. |
| 15 to 17 years old teenagers | – | Other: focus group interviewSemi-structured discussion group with older teenagers, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on the feelings of these patients suffering from severe dysmenorrhea. |
| 11 to 14 years old teenagers' parents | – | Other: focus group interviewSemi-structured discussion group with parents of young teenagers, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on the feelings of the parents on the care and feelings of their child suffering from severe dysmenorrhea. |
| 15 to 17 years old teenagers' parents | – | Other: focus group interviewSemi-structured discussion group with parents of older teenagers, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on the feelings of the parents on the care and feelings of their child suffering from severe dysmenorrhea. |
| caregivers | – | Other: focus group interviewSemi-structured discussion group with medical staff in services potentially treating dysmenorrhea patients, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on the feelings of the caregivers on the care and feelings of the patients suffering from severe dysmenorrhea. |
Who may qualify
- Ages
- 11 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 3 types of population with a link to severe dysmenorrhea (whether through their own story, or child, or profession described throught eligibility criteria above)
Key inclusion criteria (8 listed)
- For " teenage" groups:
- For "parents" groups:
- o Parent (mother or father) of an adolescent patient consulting for severe dysmenorrhea
- For "medical staff" groups:
Key exclusion criteria (7 listed)
- For " teenage" groups:
- For "parents" groups:
- o Parents whose adolescent opposes their participation in this study
- For "medical staff" groups:
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 |
|---|---|---|
| focus group interviewGroup interview gathering words, views, symptoms and its repercussions, and main issues of the subjects regarding severe dysmenorrhea | Other | 11 to 14 years old teenagers, 11 to 14 years old teenagers' parents, 15 to 17 years old teenagers, 15 to 17 years old teenagers' parents, caregivers |
Primary outcome
main themes emerging from focus group
Time frame: up to one year
qualitative outcome : identifying the main verbatim used during the focus group
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 4 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Dysmenorrhea
Not yet recruiting
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
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Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
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The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
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.
Agnès SUC, MD principal investigator
University Hospital, Toulouse
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 Dysmenorrhea, run by University Hospital, Toulouse 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 8 inclusion and 7 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 4 Nov 2022. 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?
main themes emerging from focus group (time frame: up to one year). 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 4 Nov 2022.