Dysmenorrhea Exploration in Teenagers, Their Parents and Caregivers

NCT05414825 | Completed

• 1 other identifier: RC31/22/0120
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea

Keywords

Endometriosis; severe dysmenorrhea; pain; teenagers; pediatric; qualitative research; focus group; patient care management

Outcome Measures

Primary Outcomes (1)

• main themes emerging from focus group

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

  up to one year

Study Arms (5)

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

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

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

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

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

Interventions

focus group interview 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; 11 to 14 years old teenagers' parents; 15 to 17 years old teenagers; 15 to 17 years old teenagers' parents; caregivers

Eligibility Criteria

• Age: 11 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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…)

You may not qualify if:

• 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:

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Fondation pour la Recherche Médicale: collaborator

Study Sites (1)

Uh Toulouse

Toulouse, Occitanie, 31000, France

Location

MeSH Terms

Conditions

Dysmenorrhea; Endometriosis; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Agnès SUC, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: June 10, 2022
• Study Start: August 29, 2022
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)