Dysmenorrhea Exploration in Teenagers, Their Parents and Caregivers (DEMETER)

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.

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• France
  • Occitanie
    • Toulouse, Occitanie, France, 31000
      • Uh Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
main themes emerging from focus group	qualitative outcome : identifying the main verbatim used during the focus group	up to one year

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Fondation pour la Recherche Médicale
• Investigators: Principal Investigator: Agnès SUC, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: pain; pediatric; Endometriosis; patient care management; teenagers; qualitative research; focus group; severe dysmenorrhea
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: RC31/22/0120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No