Intervention in Executive Functions and Emotional Self-Regulation in Adolescents With Primary Dys… (NCT07555886) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intervention in Executive Functions and Emotional Self-Regulation in Adolescents With Primary Dysmenorrhea
Mexico35 participantsStarted 2026-08-30
Plain-language summary
Primary dysmenorrhea is one of the most common gynecological conditions during adolescence and is associated not only with recurrent menstrual pain, but also with emotional disturbances and difficulties in behavioral regulation. Various studies have indicated that hot executive functions-linked to emotional processing, decision-making in affective contexts, and impulse control-play a relevant role in the experience of and coping with pain.
The present project aims to design and evaluate the effectiveness of a structured psychological intervention focused on strengthening hot executive functions and emotional self-regulation in adolescents with primary dysmenorrhea. A quasi-experimental design with pre- and post-intervention assessment is proposed, using validated instruments to measure pain intensity, coping strategies, and executive-emotional performance. The intervention is expected to contribute to a reduction in perceived pain and to improvements in emotional regulation strategies, promoting more adaptive coping. This study seeks to provide empirical evidence on brief psychological interventions aimed at the comprehensive management of menstrual pain in adolescent populations.
Who can participate
Age range
15 Years – 18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria Gender: menstruating individuals in late adolescence.
* Age: 15 to 19 years.
* Estimated IQ above 80.
* With painful menstrual cycles (primary dysmenorrhea) without a prior gynecological diagnosis.
* Students at the institution selected for the intervention.
* Written expression of willingness and interest in participating in the program (informed consent in the case of minors)
* Informed consent signed by parents (in the case of minors) or by the participants (in the case of adults).
* Attendance of at least 70% of the intervention sessions.
Exclusion criteria
* Ages other than those previously indicated.
* An estimated IQ below 80.
* A prior gynecological diagnosis of a condition other than dysmenorrhea.
* Pharmacological or hormonal treatment that could, in and of itself, interfere with executive functions, pain perception, and emotional regulation.
* With psychiatric and/or neurological conditions that, in and of themselves, affect executive functions and emotional regulation.
* With pain-free menstrual cycles.
* Lack of interest or willingness to participate in the program
* Lack of informed consent or assent.
Elimination criteria
* Voluntary withdrawal from the program.
* Missing more than 30% of the sessions.
* Withdrawal of informed consent (personal, from guardians, or institutional).
* Receiving a diagnosis that meets any of the exclusion criteria during the -intervention program.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Menstrual pain
Timeframe: Pre-post intervention evaluation, after 8 weeks