Completed

NCT Number: NCT05414825

Dysmenorrhea Exploration in Teenagers, Their Parents and Caregivers

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.

Completed

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Key information

Conditions

Dysmenorrhea Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

11 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Toulouse

Toulouse, Occitanie, 31000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

For "medical staff" groups:

Member of a consultation receiving adolescent patients with severe dysmenorrhea
All type of professionals (nurses, psychologist, doctors…)

Exclusion criteria

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

Treatment and study plan

Focus group interview

Other

Group interview gathering words, views, symptoms and its repercussions, and main issues of the subjects regarding severe dysmenorrhea

Primary outcomes

main themes emerging from focus group

Time frame: up to one year

qualitative outcome : identifying the main verbatim used during the focus group

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

Fondation pour la Recherche Médicale

Registry information

Official study title

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

Acronym: DEMETER

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jun 10, 2022
Registry last updated: Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed