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

Not Applicable

Active, not recruiting

• Conditions: Climacteric Symptoms; Climactericum; Self Care

• Registration Number: NCT07165964
• Lead Sponsor: University of Barcelona

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-07-31
• Study First Submitted: 2025-08-12
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale	Baseline and one month post-intervention	The SMP multifactorial scale consists of 39 items that are distributed among 6 factors: Personal Satisfaction, Prosocial Attitude, Self-Control, Autonomy, Problem Solving and Self-Update, and Interpersonal Relationship Skills. The evaluation of each item is done with a scale scale ranging from 1 to 4. Being 1, always or almost always, 2, quite often, 3 often and 4, never or almost never. Finally, a score between 39 and 156 is obtained, the higher the score the more positive mental health.
Changes observed in the severity and number of symptoms within the somatic-vegetative, psychological, and urogenital domains during the climacteric.	Baseline and one month post-intervention	The level of symptoms associated with the climacteric will be measured using the Menopause Rating Scale (MRS), a validated instrument that assesses the somatic-vegetative, psychological, and urogenital domains. The scale will be administered before and after the intervention to evaluate changes in symptom intensity across these domains.
Levels of self-care capacity will be assessed using a validated instrument: the Agency for Self-Care Assessment Scale	Baseline and one month post-intervention	The Self-Care Agency Scale (ASA) (Evers and Isenberg, 1989) is a tool designed to assess an individual's overall capacity for self-care. The scale consists of 24 items (16 positive items and 8 negative items), with questions 2, 6, 11, 13, 14, 15, 20 and 23 reverse-scored for the purpose of analysis. The scale utilised is of a Likert-type design, incorporating four possible responses that are tallied for the purpose of analysis. The participants were asked to indicate their level of agreement or disagreement with the following statements using a scale of 1 to 4: 1 = Strongly Disagree, 2 = Disagree, 3 = Agree, 4 = Total Agreement. The results of this study range from 24 (minimum self-care ability) to 96 (maximum self-care ability), thus establishing a cut-off point of \<48 to define low self-care ability.

Trial Locations

Locations (1)

Universitat de Barceñpma; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain