DysmenorrheaLADYNCT07786688
Prevalence of Childhood Maltreatment Among Women With Dysmenorrhea.
A study testing CTQ short version in people with Dysmenorrhea, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 53 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- CTQ short version
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 53 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients consulting a gynecologist for dysmenorrhea, speaking and understanding French.
- Patients affiliated to a social security system
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The short version of the CTQ is a questionnaire comprising five subscales of maltreatment (emotional and physical neglect, sexual, physical, and emotional abuse), validated by several international studies and in the French-speaking population. The study will be offered to patients consulting the Gynecology Department of Estaing University Hospital for dysmenorrhea. An information sheet will be given to them at the end of the consultation. Participants will be contacted by phone within 48 business hours following the consultation to provide additional explanations about the study. These calls will be recorded in the patient's medical file. An email will then be sent containing a link to access the short version of the CTQ questionnaire, along with a consent form. By offering participants the opportunity to answer intimate questions outside the consultation setting, for example at home or in a place where they feel safe and comfortable, more authentic and relevant responses are expected. A reminder email will be sent to patients who have not responded to the online questionnaire on days 5, 10, and 15. Patients whose score corresponds to a history of maltreatment will be offered an appointment within a maximum of 15 days with a gynecologist specialized in victimology, in order to provide the care best suited to their needs (assessment, explanations, legal or psychological support procedures, referral to support associations, targeted gynecological follow-up). The patient will be contacted again 3 months later (in person or by phone) to assess treatment efficacy and satisfaction.
- Conditions
- Dysmenorrhea
- Being tested
- CTQ short version
- Keywords
- dysmenorrhea, chronic pain, children maltreatment, violence
- Medical subject headings
- Dysmenorrhea, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTQ short versionDiagnostic test
Also called Appointment in a specific service
We propose a medical appointment to all the women with a positive score at the CTQ short version
| Study group | Role | What they receive |
|---|---|---|
| Children maltreatment | Other | We propose a medical appointment only to women who had suffered from children maltreatment Receives: Diagnostic Test: CTQ short version |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of childhood abuse
The prevalence (percentage) of childhood abuse in a population of women suffering from dysmenorrhea.
Measured: Day 15, at 3 months
Secondary outcomes (6)
Prevalence of different forms of violence during childhood
The prevalence (percentage) of different forms of violence (sexual, physical or emotional) during childhood in a population of women suffering from dysmenorrhea
Measured: Day 15, at 3 months
Type of Dysmenorrhea (Primary versus Secondary), by CTQ Status
Classification of dysmenorrhea as primary (functional, in the absence of identifiable pelvic pathology) or secondary (organic, in the presence of a documented gynecological condition recorded in the medical file: endometriosis, adenomyosis, uterine fibroids, ovarian cyst, uterine malformation, history of salpingitis). The distribution between the two forms will be compared according to overall CTQ (Childhood Trauma Questionnaire) status and by domain of maltreatment.
Measured: 15 jours
Type and Quantity of Analgesics Consumed by Patients, by CTQ Status
Analgesic consumption recorded from the medical file, classified according to the WHO analgesic ladder (step I, II, or III), along with the maximum number of daily doses. The proportion of exposed patients will be compared according to overall CTQ (Childhood Trauma Questionnaire) status and by domain of maltreatment (emotional neglect, emotional abuse, physical neglect, physical abuse, sexual abuse).
Measured: Day 15
Type of Contraceptive Method Used by Patients, by CTQ Status
Contraceptive method recorded from the medical file (none, oral contraception, intrauterine device, implant, patch, vaginal ring, condoms, tubal ligation, vasectomy). The proportion of patients by contraceptive type will be compared according to overall CTQ (Childhood Trauma Questionnaire) status and by domain of maltreatment (emotional neglect, emotional abuse, physical neglect, physical abuse, sexual abuse)
Measured: Day 15
Visual Analogue Scale (VAS) Score for Dysmenorrhea, by CTQ Status
Intensity of menstrual pain assessed using a Visual Analogue Scale (VAS), scored from 0 (no pain) to 10 (worst pain imaginable). Mean VAS scores will be compared according to overall CTQ (Childhood Trauma Questionnaire) status and by domain of maltreatment (emotional neglect, emotional abuse, physical neglect, physical abuse, sexual abuse), as well as by the cumulative number of forms of childhood violence experienced.
Measured: Day 15
Patient's satisfaction with the medical care
3 months later, is the patient satisfied with the medical care proposed in victimology : YES or NO ?
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start25 Jul 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786688
- Sponsor's protocol ID
- RBHP 2023 BOUCHET
- Acronym
- LADY
- Status last verified
- Aug 2026
- First submitted
- 14 May 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9055514Bernstein 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.
PubMed 12615092Paquette 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.
PubMed 15470573Gordon 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.
PubMed 34499948Unnisa 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.
PubMed 36147090ACOG Committee Opinion No. 760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018 Dec;132(6):e249-e258. doi: 10.1097/AOG.0000000000002978.
PubMed 30461694Sachedina 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.
PubMed 32041388Moussaoui 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.
PubMed 35569788Liebschutz 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.
PubMed 18601725
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Childhood Maltreatment Among Women With Dysmenorrhea.
- ClinicalTrials.gov ID
- NCT07786688
- Acronym / sponsor ID
- LADY / RBHP 2023 BOUCHET
- Conditions
- Dysmenorrhea
- Keywords
- dysmenorrhea, chronic pain, children maltreatment, violence
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The short version of the CTQ is a questionnaire comprising five subscales of maltreatment (emotional and physical neglect, sexual, physical, and emotional abuse), validated by several international studies and in the French-speaking population. The study will be offered to patients consulting the Gynecology Department of Estaing University Hospital for dysmenorrhea. An information sheet will be given to them at the end of the consultation. Participants will be contacted by phone within 48 business hours following the consultation to provide additional explanations about the study. These calls will be recorded in the patient's medical file. An email will then be sent containing a link to access the short version of the CTQ questionnaire, along with a consent form. By offering participants the opportunity to answer intimate questions outside the consultation setting, for example at home or in a place where they feel safe and comfortable, more authentic and relevant responses are expected. A reminder email will be sent to patients who have not responded to the online questionnaire on days 5, 10, and 15. Patients whose score corresponds to a history of maltreatment will be offered an appointment within a maximum of 15 days with a gynecologist specialized in victimology, in order to provide the care best suited to their needs (assessment, explanations, legal or psychological support procedures, referral to support associations, targeted gynecological follow-up). The patient will be contacted again 3 months later (in person or by phone) to assess treatment efficacy and satisfaction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children maltreatment | Other | Diagnostic Test: CTQ short versionWe propose a medical appointment only to women who had suffered from children maltreatment |
Who may qualify
- Ages
- 18 to 53 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients consulting a gynecologist for dysmenorrhea, speaking and understanding French.
- Patients affiliated to a social security system
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTQ short versionAlso: Appointment in a specific serviceWe propose a medical appointment to all the women with a positive score at the CTQ short version | Diagnostic test | Children maltreatment |
Primary outcome
Prevalence of childhood abuse
Time frame: Day 15, at 3 months
The prevalence (percentage) of childhood abuse in a population of women suffering from dysmenorrhea.
6 secondary outcomes
Prevalence of different forms of violence during childhood
Time frame: Day 15, at 3 months
Type of Dysmenorrhea (Primary versus Secondary), by CTQ Status
Time frame: 15 jours
Type and Quantity of Analgesics Consumed by Patients, by CTQ Status
Time frame: Day 15
Type of Contraceptive Method Used by Patients, by CTQ Status
Time frame: Day 15
Visual Analogue Scale (VAS) Score for Dysmenorrhea, by CTQ Status
Time frame: Day 15
Patient's satisfaction with the medical care
Time frame: At 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 9055514Bernstein 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.
- Background: PubMed 12615092Bernstein 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.
- Background: PubMed 15470573Paquette 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.
- Background: PubMed 34499948Gordon 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.
- Background: PubMed 36147090Unnisa 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.
- Background: PubMed 30461694ACOG Committee Opinion No. 760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018 Dec;132(6):e249-e258. doi: 10.1097/AOG.0000000000002978.
- Background: PubMed 32041388Sachedina 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.
- Background: PubMed 35569788Moussaoui 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.
- Background: PubMed 18601725Liebschutz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTQ short version in people with Dysmenorrhea, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of childhood abuse (time frame: Day 15, at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07786688, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.