NCT07786688

Brief Summary

Dysmenorrhea is defined by the French National College of Gynecologists and Obstetricians as "cyclic abdominopelvic pain, occurring around menstruation, beginning shortly before its onset and sometimes persisting afterward." Its prevalence is difficult to determine precisely, but studies show that 16 to 90% of women in the general population experience permanent or occasional dysmenorrhea, and that more than 20% of them must limit their activities during menstruation. The origins of this pain remain poorly understood, but it is now known to be associated with significant emotional, psychological, and functional health consequences. Several studies have demonstrated that a history of violence experienced during childhood and adolescence is associated with the onset of chronic pain, but to the investigators' knowledge, no study has specifically analyzed the impact of violence on the presence of dysmenorrhea in adulthood. This study aims to administer a questionnaire assessing dysmenorrhea and history of violence (Childhood Trauma Questionnaire, short French version - CTQ) to patients consulting the Gynecology Department of Estaing University Hospital for menstrual pain (dysmenorrhea). The investigators aim to identify an association between the presence of dysmenorrhea and a history of violence during childhood.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Jul 2024Oct 2027

First Submitted

Initial submission to the registry

May 14, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

3.2 years

First QC Date

May 14, 2024

Last Update Submit

August 21, 2026

Conditions

Keywords

dysmenorrheachronic painchildren maltreatmentviolence

Outcome Measures

Primary Outcomes (1)

  • Prevalence of childhood abuse

    The prevalence (percentage) of childhood abuse in a population of women suffering from dysmenorrhea.

    Day 15, at 3 months

Secondary Outcomes (6)

  • Prevalence of different forms of violence during childhood

    Day 15, at 3 months

  • Type of Dysmenorrhea (Primary versus Secondary), by CTQ Status

    15 jours

  • Type and Quantity of Analgesics Consumed by Patients, by CTQ Status

    Day 15

  • Type of Contraceptive Method Used by Patients, by CTQ Status

    Day 15

  • Visual Analogue Scale (VAS) Score for Dysmenorrhea, by CTQ Status

    Day 15

  • +1 more secondary outcomes

Study Arms (1)

Children maltreatment

OTHER

We propose a medical appointment only to women who had suffered from children maltreatment

Diagnostic Test: CTQ short version

Interventions

CTQ short versionDIAGNOSTIC_TEST

We propose a medical appointment to all the women with a positive score at the CTQ short version

Also known as: Appointment in a specific service
Children maltreatment

Eligibility Criteria

Age18 Years - 53 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGender identity
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients consulting a gynecologist for dysmenorrhea, speaking and understanding French.
  • Patients affiliated to a social security system

You may not qualify if:

  • Refusal to participate
  • Inability to answer the questionnaire due to insufficient fluency in French
  • Minor patients (age \< 18)
  • Presence of cognitive disorders limiting the ability to complete the questionnaire
  • Patients with hysterectomy or adnexectomy
  • Patients under curators/guardianship/legal guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Related Publications (9)

  • Bernstein DP, Ahluvalia T, Pogge D, Handelsman L. Validity of the Childhood Trauma Questionnaire in an adolescent psychiatric population. J Am Acad Child Adolesc Psychiatry. 1997 Mar;36(3):340-8. doi: 10.1097/00004583-199703000-00012.

    PMID: 9055514BACKGROUND
  • Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.

    PMID: 12615092BACKGROUND
  • Paquette D, Laporte L, Bigras M, Zoccolillo M. [Validation of the French version of the CTQ and prevalence of the history of maltreatment]. Sante Ment Que. 2004 Spring;29(1):201-20. doi: 10.7202/008831ar. French.

    PMID: 15470573BACKGROUND
  • Gordon JB. The importance of child abuse and neglect in adult medicine. Pharmacol Biochem Behav. 2021 Dec;211:173268. doi: 10.1016/j.pbb.2021.173268. Epub 2021 Sep 7.

    PMID: 34499948BACKGROUND
  • Unnisa H, Annam P, Gubba NC, Begum A, Thatikonda K. Assessment of quality of life and effect of non-pharmacological management in dysmenorrhea. Ann Med Surg (Lond). 2022 Aug 30;81:104407. doi: 10.1016/j.amsu.2022.104407. eCollection 2022 Sep.

    PMID: 36147090BACKGROUND
  • ACOG Committee Opinion No. 760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018 Dec;132(6):e249-e258. doi: 10.1097/AOG.0000000000002978.

    PMID: 30461694BACKGROUND
  • Sachedina A, Todd N. Dysmenorrhea, Endometriosis and Chronic Pelvic Pain in Adolescents. J Clin Res Pediatr Endocrinol. 2020 Feb 6;12(Suppl 1):7-17. doi: 10.4274/jcrpe.galenos.2019.2019.S0217.

    PMID: 32041388BACKGROUND
  • Moussaoui D, Grover SR. The Association between Childhood Adversity and Risk of Dysmenorrhea, Pelvic Pain, and Dyspareunia in Adolescents and Young Adults: A Systematic Review. J Pediatr Adolesc Gynecol. 2022 Oct;35(5):567-574. doi: 10.1016/j.jpag.2022.04.010. Epub 2022 May 13.

    PMID: 35569788BACKGROUND
  • Liebschutz J, Battaglia T, Finley E, Averbuch T. Disclosing intimate partner violence to health care clinicians - what a difference the setting makes: a qualitative study. BMC Public Health. 2008 Jul 4;8:229. doi: 10.1186/1471-2458-8-229.

    PMID: 18601725BACKGROUND

MeSH Terms

Conditions

DysmenorrheaChronic Pain

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2024

First Posted

August 26, 2026

Study Start

July 25, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations