Intervention in Executive Functions and Emotional Self-Regulation in Adolescents With Primary Dysmenorrhea

NCT07555886 | Not Yet Recruiting DMC

• 1 other identifier: MP/2026/JSB
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menstrual Cramps

Keywords

Menstruation; Adolescents; Emotional regulation; Hot executive functioning; Primary dysmenorrhea.

Outcome Measures

Primary Outcomes (1)

• Menstrual pain

  A Visual Analog Scale (VAS) (Hayes, MHS, \& Patterson, DG (1921). Experimental development of the graphical rating method. Psychological Bulletin, 18) is a psychometric tool used to measure subjective and continuous phenomena such as pain, mood, or appetite. It typically consists of a 10 cm (100 mm) horizontal line anchored by opposite endpoints (e.g., "no pain" to "the worst pain imaginable"). The patient marks a point on the line corresponding to their current intensity. The distance (in mm) from the left anchor ("no pain") to the mark is measured, yielding a score from 0 to 100. Higher scores indicate greater severity. Typical cutoff points are: 0-4 mm (painless), 5-44 mm (mild), 45-74 mm (moderate), and 75-100 mm (severe). It is commonly used in clinical settings to assess symptoms, monitor treatment progress, or measure health-related quality of life. While the horizontal scale is the standard, vertical lines or digital "slider

  Pre-post intervention evaluation, after 8 weeks

Secondary Outcomes (4)

• Executive functioning

  Pre-post intervention evaluation, after 8 weeks

• Stroop test

  Pre-post intervention evaluation, after 8 weeks

• Gambling test

  Pre-post intervention evaluation, after 8 weeks

• Emotion Regulation

  Pre-post intervention evaluation, after 8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive an intervention aimed at coping with menstrual pain, as well as education on gynecological health.

Behavioral: Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain.

control group

NO INTERVENTION

They will not receive a psychological intervention; this group will serve as a comparison/control group to evaluate changes in the way participants cope with pain.

Interventions

Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain. BEHAVIORAL

The intervention arm will receive a program based on cognitive restructuring techniques. The intervention will be aimed at identifying, questioning, and modifying negative automatic thoughts and cognitive distortions that influence participants' emotions and behaviors. During the sessions, strategies characteristic of the cognitive-behavioral approach will be used, such as thought monitoring/recording, identification of dysfunctional beliefs, analysis of evidence supporting and contradicting those thoughts, and the generation of more adaptive alternative interpretations. Activities will be carried out through guided exercises, discussion of examples, and structured practice designed to help participants apply these techniques to everyday life situations.

Intervention group

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Universidad Autonoma de Baja California

Mexicali, Estado de Baja California, 21700, Mexico

Location

MeSH Terms

Conditions

Dysmenorrhea; Emotional Regulation

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Self-Control; Social Behavior; Behavior

Central Study Contacts

JAZMIN SALAS, MASTERY

CONTACT

+526861187406; jazminsalas121@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full-time researcher

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): March 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

ME (1)