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

Universidad Autonoma de Baja California

Status: Begins enrollment in 2 months

Conditions: Menstrual Cramps

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07555886

MP/2026/JSB

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 estimated patients

Sex: Female

Ages: 15 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

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

control group

No Intervention group

Description:

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.