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Набор скоро начнётся NCT07555886

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

Без фазы С лечением Menstrual Cramps

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain..
Кому может быть актуально
Состояния в реестре: Menstrual Cramps. Базовые параметры: 15 лет — 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Мексика
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluación de Una intervención psicológica Sobre Funciones Ejecutivas cálidas y autorregulación Emocional en Adolescentes Con Dismenorrea Primaria

Обзор

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.

Подробное описание

Primary dysmenorrhea is one of the most common gynecological conditions during adolescence and is characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. Its onset typically coincides with the first years following menarche and is primarily associated with increased production of endometrial prostaglandins, leading to uterine hypercontractility, reduced blood flow, ischemia, and pain. However, although its physiological basis is well documented, the experience of menstrual pain cannot be explained solely from a biomedical perspective. Its high prevalence among adolescents and its impact on academic performance, social life, and emotional well-being highlight the need to understand it from a more comprehensive framework.

The biopsychosocial model of pain proposes that the pain experience results from the interaction of biological, psychological, and social factors. From this perspective, variables such as beliefs about pain, cognitive appraisal of the experience, anticipatory anxiety, and coping strategies significantly influence perceived intensity and functional impairment. During adolescence, this interaction becomes particularly relevant due to hormonal changes and ongoing brain reorganization characteristic of this developmental stage. The limbic system, involved in emotional processing, exhibits heightened reactivity, whereas the prefrontal cortex-responsible for inhibitory control and regulation-continues to mature. This neurobiological asynchrony may contribute to intensified emotional responses to pain and difficulties in regulating them adaptively.

In this context, executive functions play a central role. These functions comprise a set of higher-order cognitive processes that enable planning, inhibition of automatic responses, decision-making, and goal-directed behavior regulation. Within this framework, hot executive functions are associated with emotional processing and decision-making in affectively charged situations. Unlike cold executive functions, which operate in abstract and emotionally neutral contexts, hot executive functions are engaged when decisions involve reward, punishment, or distress. In situations of menstrual pain, these functions influence the interpretation of discomfort, anticipation of pain episodes, and selection of coping strategies. Difficulties in these areas may be associated with greater emotional impulsivity, lower distress tolerance, and a predominance of avoidant or maladaptive coping strategies, potentially amplifying the subjective perception of pain.

Emotional self-regulation, closely linked to hot executive functions, refers to the ability to identify, understand, and flexibly modulate one's emotions in an adaptive manner. Among adolescents with primary dysmenorrhea, anticipatory anxiety, fear of pain, or catastrophizing thoughts may intensify the pain experience and increase interference in daily activities. Difficulties in applying strategies such as cognitive reappraisal, acceptance, or attentional control may contribute to a more intense and prolonged experience of distress. Conversely, the development of emotional regulation skills has been associated with better adaptation to pain and reduced functional impact.

Although pharmacological treatment represents the first-line management approach for primary dysmenorrhea, not all adolescents experience satisfactory relief, particularly regarding the emotional components associated with pain. In recent years, various psychological interventions based on psychoeducation, cognitive-behavioral therapy, relaxation techniques, and coping skills training have shown promising results in reducing pain intensity and improving quality of life. However, there remains a gap in the literature regarding interventions that specifically integrate the strengthening of hot executive functions as a central component of treatment.

Considering that adolescence represents a critical period for the development of executive functions and the consolidation of emotional self-regulation skills, designing a psychological intervention aimed at strengthening these capacities may have a significant impact on the experience of menstrual pain.

Вмешательства

  • Поведенческое Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain.
    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 tho

Первичные конечные точки

  • Menstrual pain [Срок оценки: Pre-post intervention evaluation, after 8 weeks]
Вторичные конечные точки (4)
  • Executive functioning [Срок оценки: Pre-post intervention evaluation, after 8 weeks]
  • Stroop test [Срок оценки: Pre-post intervention evaluation, after 8 weeks]
  • Gambling test [Срок оценки: Pre-post intervention evaluation, after 8 weeks]
  • Emotion Regulation [Срок оценки: Pre-post intervention evaluation, after 8 weeks]

Критерии участия

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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Мексика · 1 центр
  • Universidad Autonoma de Baja California — Mexicali

Идентификаторы

NCT: NCT07555886 · MP/2026/JSB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗