Menstrual CrampsCALMANCT07555886
Intervention in Executive Functions and Emotional Self-Regulation in Adolescents With Primary Dysmenorrhea
A study testing Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain. in people with Menstrual Cramps, run by Universidad Autonoma de Baja California at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 years, women only
- Conditions the study is for
- Menstrual Cramps
- What is being tested?
- Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- 30 Aug 2026to 30 Mar 2028
- 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 15 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Universidad Autonoma de Baja California
Mexicali, Estado de Baja California, 21700
About this study
Official title: Evaluación de Una intervención psicológica Sobre Funciones Ejecutivas cálidas y autorregulación Emocional en Adolescentes Con Dismenorrea Primaria
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.
Read the detailed 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.
- Conditions
- Menstrual Cramps
- Being tested
- Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain.
- Keywords
- Menstruation, Adolescents, Emotional regulation, Hot executive functioning, Primary dysmenorrhea.
- Medical subject headings
- Dysmenorrhea, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive an intervention aimed at coping with menstrual pain, as well as education on gynecological health. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre-post intervention evaluation, after 8 weeks
Secondary outcomes (4)
Executive functioning
The BRIEF-2 self-report questionnaire (Gioia, Isquith, Guy, \& Kenworthy, 2017) is a 55-item questionnaire designed for adolescents (ages 11-18) to assess their own executive functions-cognitive, emotional, and behavioral regulation-in daily life. It helps identify the strengths and weaknesses perceived by the adolescent themselves, complementing reports from parents and teachers to guide interventions, especially in cases of ADHD, autism, and learning difficulties. Interpretation is based on T-scores (with a mean of 50 and a standard deviation of 10), which are the standard for determining the clinical significance of executive functions. This instrument has undergone several adaptations for the Mexican population.
Measured: Pre-post intervention evaluation, after 8 weeks
Stroop test
Stroop test, will be measured from the standardized executive function test BANFE ( Neuropsychological Battery for Executive Functions and Frontal Lobes), using accuracy of response, stroop type error, no-Stroop errors, and time, Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).
Measured: Pre-post intervention evaluation, after 8 weeks
Gambling test
Gambling test, will be measured by calculating EF quotients from the standardized test BANFE (Neuropsychological Battery for Executive Functions and Frontal Lobes) using risk cards percentage, final total score. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).
Measured: Pre-post intervention evaluation, after 8 weeks
Emotion Regulation
The Difficulties in Emotion Regulation Scale (DERS) (Gratz y Roemer, 2004) is a 36-item, self-report questionnaire designed to measure a person's typical levels of emotion dysregulation across six domains: nonacceptance of emotions, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to regulation strategies, and lack of clarity. Raw scores range from 36 to 180. Higher scores indicate greater difficulties with emotional regulation. A high score suggests difficulties in accepting emotions, a lack of effective strategies, and impulsive dyscontrol in response to distress.This instrument has been validated and adapted for the target population.
Measured: Pre-post intervention evaluation, after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CrampsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilberto Galindo, Universidad Autonoma de Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555886
- Sponsor's protocol ID
- MP/2026/JSB
- Acronym
- CALMA
- Status last verified
- May 2026
- First submitted
- 25 Mar 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluación de Una intervención psicológica Sobre Funciones Ejecutivas cálidas y autorregulación Emocional en Adolescentes Con Dismenorrea Primaria
- ClinicalTrials.gov ID
- NCT07555886
- Acronym / sponsor ID
- CALMA / MP/2026/JSB
- Conditions
- Menstrual Cramps
- Keywords
- Menstruation, Adolescents, Emotional regulation, Hot executive functioning, Primary dysmenorrhea.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 29 Apr 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain.Participants will receive an intervention aimed at coping with menstrual pain, as well as education on gynecological health. |
| 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. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| 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 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. | Behavioural | Intervention group |
Primary outcome
Menstrual pain
Time frame: Pre-post intervention evaluation, after 8 weeks
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
4 secondary outcomes
Executive functioning
Time frame: Pre-post intervention evaluation, after 8 weeks
Stroop test
Time frame: Pre-post intervention evaluation, after 8 weeks
Gambling test
Time frame: Pre-post intervention evaluation, after 8 weeks
Emotion Regulation
Time frame: Pre-post intervention evaluation, after 8 weeks
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 18 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain. in people with Menstrual Cramps, run by Universidad Autonoma de Baja California at 1 site in Mexico.
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 0 inclusion and 13 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: opening soon, as of the sponsor's last update on 18 May 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 Mexico. 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?
Contact JAZMIN SALAS, MASTERY (+526861187406, jazminsalas121@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual pain (time frame: Pre-post intervention evaluation, after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2026.