Nursing Interventions to Enhance Positive Mental Health and Self Care in Women During the Climacteric

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will test whether a nursing program using podcasts and videos can help women feel better and take better care of themselves during the climacteric (the stage leading up to and following menopause). Women between 42 and 58 years old who attend public sexual and reproductive health clinics in the Metropolitan South Health Region of Barcelona (Sant Boi, Sant Feliu, and Cornellà) will be invited to participate.

Participants will be randomly assigned to one of two groups:

Intervention Group: will receive access to podcasts and videos offering practical advice and strategies to improve emotional well-being and self-care.

Control Group: will receive standard care. All participants will complete questionnaires before and after the program to assess symptoms, mental health, and satisfaction with self-care. Statistical methods will be used to compare the results between both groups and determine whether the program produces a significant difference.

The aim of the study is to demonstrate that this digital nursing intervention is effective and could be implemented more broadly in healthcare settings.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Symptom Monitoring and Menopausal Symptoms

NCT05603234

Menopause

COMPLETED NA

Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause

NCT04922385

Perimenopause Sexual Concerns

UNKNOWN NA

Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

NCT06975111

Menopause Menopause Hot Flashes Menopause Related Conditions +1 more

NOT_YET_RECRUITING PHASE2/PHASE3

Diet, Cardiometabolic Risk (CM) and Menopause Symptoms

NCT05764473

Metabolic Syndrome, Protection Against Menopause

COMPLETED NA

The Menopause After Cancer Study

NCT04766229

Menopause Cancer Insomnia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Self-Care and Positive Mental Health During the Climacteric Stage: Conceptual Framework and Social Relevance

Self-care is a fundamental human function, particularly vital during the climacteric stage, when women experience significant physical, emotional, and social changes. The conceptual foundation of this project is Dorothea Orem's General Theory of Self-Care Deficit, which encompasses both the individual's capacity for self-care and their ability to care for others. Orem defines self-care as "the personal actions undertaken and performed by each individual to maintain life, health, and well-being, and to consistently respond to their health needs."

Despite the importance of this life stage, the scientific literature indicates that most interventions targeting health issues in women during the climacteric have been non-holistic, often addressing physical and emotional aspects in isolation. There is a notable lack of empirical evidence supporting interventions that simultaneously promote self-care and positive mental health (PMH) in menopausal women. Existing studies tend to focus on problem-solving strategies, lifestyle modifications, and empowerment programs aimed at improving quality of life. However, no specific programs have been identified that address PMH in this population.

Both PMH and self-care capacity are essential constructs for women adapting to the multifaceted changes of the climacteric. Enhancing these dimensions may contribute significantly to health promotion during this extended phase of the female life cycle, which is often marked by conditions that negatively impact quality of life. Research suggests that psychosocial factors such as optimism, emotional stability, and self-esteem are positively associated with well-being and resilience. Moreover, several studies support a bidirectional relationship between self-care and PMH, indicating that improvements in one domain can reinforce the other. A notable example is the PiPsE program, which aims to enhance PMH in individuals with chronic illnesses.

The outcomes of this project are expected to advance the field of women's health by deepening our understanding of the needs of women during the menopausal transition, particularly in relation to PMH and self-care. These findings may inform the development of tailored intervention programs that support women's health across all stages of menopause, aligning with broader health promotion and disease prevention policies.

This proposal aligns with Strategic Line DEM.2.2.4 of the III Strategic Plan for Effective Equality of Women and Men (2022-2025), which advocates for "the implementation of sexual and reproductive health programs at all life stages." By addressing the menopausal stage-a period often overlooked in empirical research-this project contributes to a more comprehensive understanding of women's health. Furthermore, incorporating a gender perspective in health research is essential to correcting and eliminating gender biases in the diagnosis, treatment, and conceptualization of women's physiological and psychological processes. This study promotes a positive, health-affirming approach to women's physical and mental well-being, centering the voices of menopausal women as primary stakeholders.

Utility and Relevance for Social Sectors

This innovative project reorients the focus of women's sexual health from the reproductive phase to its conclusion-menopause-during which women undergo a range of physical, psychoemotional, and social transformations. It is imperative that society recognize and value the resilience and strength of women in this stage, beyond their reproductive roles. Accordingly, this project seeks to highlight women's psychoemotional capacities, self-care abilities, and the broader social significance of these attributes.

It is also essential to provide women with platforms to articulate their physical and emotional needs throughout the climacteric (pre-, peri-, and post-menopause). The findings of this study should inform the design of programs that promote PMH, emotional well-being, and self-care capacity within a health promotion framework, empowering women to take an active role in managing their health. Additionally, this research will help define a distinct domain of women's health, separate from the male sexual and reproductive trajectory.

Evidence continues to show that caregiving responsibilities disproportionately fall on women. As highlighted in the Research Team Experience section, who has long been committed to strengthening the physical and mental resilience of women caregivers through initiatives that promote PMH and self-care. During menopause, many women also assume caregiving roles for elderly dependents, which can exacerbate the physical and emotional challenges of this life stage. This underscores the urgent need to support and reinforce women's self-care-both physical and mental-during the climacteric.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Climacteric Symptoms Climactericum Self Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Model pre-post test in intervention group and pre-post usual follow up in control group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Climateric Intevention Group (IG)

Intervention Group (IG):

Participants will complete the same pre- and post-intervention assessments, including the validated scales and the ad hoc instrument used in the study.

Participants in the intervention group will receive a personal access code to a Moodle virtual campus, where they will find a series of specially designed podcasts and videos addressing self-care during the climacteric and promoting positive mental health (PMH). These digital resources-referred to as "digital pills"-have been developed by experts in the field to meet the specific needs of this population.

Each resource will be followed by a brief quiz to assess participant engagement, knowledge acquisition, and adherence. At the end of the intervention, participants will also complete a satisfaction survey. Access to the platform will remain open for two months, during which participants can view the materials and complete the quizzes at their own pace, alongside receiving usual care.

Group Type ACTIVE_COMPARATOR

Personal interventions in Climateric

Intervention Type BEHAVIORAL

The intervention group (IG) will participate in the climacteric care program. Each participant will receive a personal access code to a Moodle-based virtual campus, where they will find specially designed podcasts and videos, provided in addition to standard care. These digital "pills" have been developed by subject matter experts to support self-care during the climacteric stage and to promote positive mental health (PMH). Each resource is followed by a short quiz to assess engagement, knowledge acquisition, and adherence. A final satisfaction survey will also be included. IG participants will have two months of access to explore the content, complete the quizzes, and interact with the platform.

The intervention includes the following modules:

MODULE 1: INTRODUCTION TO THE CLIMACTERIC/MENOPAUSE MODULE 2: DIETARY HABITS AND PHYSICAL ACTIVITY MODULE 3: PSYCHOEMOTIONAL MANAGEMENT

Control Group (CG)

Control Group (CG):

Participants in the control group will complete the same pre- and post-intervention assessments, including the validated scales and the ad hoc instrument used in the study. The intervention for this group will consist of routine follow-up care provided by a midwife in primary care, focusing on the management of climacteric symptoms. No additional digital resources or structured educational content will be provided beyond standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Personal interventions in Climateric

The intervention group (IG) will participate in the climacteric care program. Each participant will receive a personal access code to a Moodle-based virtual campus, where they will find specially designed podcasts and videos, provided in addition to standard care. These digital "pills" have been developed by subject matter experts to support self-care during the climacteric stage and to promote positive mental health (PMH). Each resource is followed by a short quiz to assess engagement, knowledge acquisition, and adherence. A final satisfaction survey will also be included. IG participants will have two months of access to explore the content, complete the quizzes, and interact with the platform.

The intervention includes the following modules:

MODULE 1: INTRODUCTION TO THE CLIMACTERIC/MENOPAUSE MODULE 2: DIETARY HABITS AND PHYSICAL ACTIVITY MODULE 3: PSYCHOEMOTIONAL MANAGEMENT

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women aged 42-58 years attending the participating ASSIR centers.
* Clinically identified symptoms of climacteric during routine consultation.

Exclusion Criteria

* Cognitive or learning impairments preventing comprehension of study procedures.
* Physical, emotional, or intellectual limitations hindering completion of study instruments or participation in the intervention.
* Current treatment for hormone dependent cancer.
* Use of an intrauterine device or ongoing hormonal contraceptives.
* Other medical causes of secondary menopause.

Minimum Eligible Age

42 Years

Maximum Eligible Age

58 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No