Dysmenorrhea Exploration in Teenagers, Their Parents and Caregivers

NCT ID: NCT05414825

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-29

Study Completion Date

2022-09-13

Brief Summary

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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

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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.

Conditions

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Dysmenorrhea

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

focus group interview

Intervention Type OTHER

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.

focus group interview

Intervention Type OTHER

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.

focus group interview

Intervention Type OTHER

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.

focus group interview

Intervention Type OTHER

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.

focus group interview

Intervention Type OTHER

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

Interventions

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focus group interview

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

Intervention Type OTHER

Eligibility Criteria

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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:
Minimum Eligible Age

11 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation pour la Recherche Médicale

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agnès SUC, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Uh Toulouse

Toulouse, Occitanie, France

Site Status

Countries

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France

Other Identifiers

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RC31/22/0120

Identifier Type: -

Identifier Source: org_study_id

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