Clinical trial NCT05414825: Dysmenorrhea Exploration in Teenagers, Their Parents and Caregivers
Official title: Monocentric Descriptive Study Regarding the Impact of Severe Dysmenorrhea on Teenagers, Their Parents and Caregivers Receiving Those Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysmenorrhea
Keywords: Endometriosis
severe dysmenorrhea
pain
teenagers
pediatric
qualitative research
focus group
patient care management
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Fondation pour la Recherche Médicale
First posted: 2022-06-10
Enrollment: 27
Sex: ALL
Minimum age (years): 11
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: main themes emerging from focus group
timeFrame: up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Uh Toulouse
state: Occitanie
Study officials:
affiliation: University Hospital, Toulouse
name: Agnès SUC, MD
role: PRINCIPAL_INVESTIGATOR
References: