DEMETER: Dysmenorrhea Exploration in Teenagers, Their Parents and Caregivers

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Recruiting

CT.gov ID

NCT05414825

Collaborator

Fondation pour la Recherche Médicale (Other)

Enrollment

Location

11.1

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Dysmenorrhea	Other: focus group interview

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

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Monocentric Descriptive Study Regarding the Impact of Severe Dysmenorrhea on Teenagers, Their Parents and Caregivers Receiving Those Patients

Anticipated Study Start Date :

Aug 29, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: focus group interview Group interview gathering words, views, symptoms and its repercussions, and main issues of the subjects regarding severe dysmenorrhea
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.	Other: focus group interview Group interview gathering words, views, symptoms and its repercussions, and main issues of the subjects regarding severe dysmenorrhea
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.	Other: focus group interview Group interview gathering words, views, symptoms and its repercussions, and main issues of the subjects regarding severe dysmenorrhea
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.	Other: focus group interview Group interview gathering words, views, symptoms and its repercussions, and main issues of the subjects regarding severe dysmenorrhea
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.	Other: focus group interview Group interview gathering words, views, symptoms and its repercussions, and main issues of the subjects regarding severe dysmenorrhea

Outcome Measures

Primary Outcome Measures

main themes emerging from focus group [up to one year]
qualitative outcome : identifying the main verbatim used during the focus group

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA :

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