Dysmenorrhea Exploration in Teenagers, Their Parents and Caregivers

Dysmenorrhea Clinical Trial

— DEMETER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05414825
• Other study ID #: RC31/22/0120
• Status: Completed
• Start date: August 29, 2022
• Est. completion date: September 13, 2022

Study information

• Verified date: November 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Other:
• focus group interview
Group interview gathering words, views, symptoms and its repercussions, and main issues of the subjects regarding severe dysmenorrhea

Locations

Country	Name	City	State
France	Uh Toulouse	Toulouse	Occitanie

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Fondation pour la Recherche Médicale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	main themes emerging from focus group	qualitative outcome : identifying the main verbatim used during the focus group	up to one year