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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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, knowledg

Первичные конечные точки

• Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale [Срок оценки: Baseline and one month post-intervention]
• Changes observed in the severity and number of symptoms within the somatic-vegetative, psychological, and urogenital domains during the climacteric. [Срок оценки: Baseline and one month post-intervention]
• Levels of self-care capacity will be assessed using a validated instrument: the Agency for Self-Care Assessment Scale [Срок оценки: Baseline and one month post-intervention]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universitat de Barceñpma — L'Hospitalet de Llobregat

Публикации

• Puig Llobet M, Sanchez Ortega M, Lluch-Canut M, Moreno-Arroyo M, Hidalgo Blanco MA, Roldan-Merino J. Positive Mental Health and Self-Care in Patients with Chronic Physical Health Problems: Implications for Evidence-based Practice. Worldviews Evid Based Nurs. 2020 Aug;17(4):293-300. doi: 10.1111/wvn.12453. Epub 2020 Aug 6. PMID 32762130
• Suss H, Willi J, Grub J, Ehlert U. Psychosocial factors promoting resilience during the menopausal transition. Arch Womens Ment Health. 2021 Apr;24(2):231-241. doi: 10.1007/s00737-020-01055-7. Epub 2020 Jul 27. PMID 32719937
• Herson M, Kulkarni J. Hormonal Agents for the Treatment of Depression Associated with the Menopause. Drugs Aging. 2022 Aug;39(8):607-618. doi: 10.1007/s40266-022-00962-x. Epub 2022 Jul 30. PMID 35908135
• Gabes M, Kann G, von Sommoggy J, Stute P, Apfelbacher CJ. 'As long as I have a restroom somewhere [...], I am fine': a qualitative study on the perspectives of peri- and postmenopausal women on the impact of the urinary component of the genitourinary syndrome of menopause (GSM). BMC Womens Health. 2021 Nov 8;21(1):391. doi: 10.1186/s12905-021-01523-x. PMID 34743728
• Khalil J, Boutros S, Kheir N, Kassem M, Salameh P, Sacre H, Akel M, Obeid S, Hallit S. Eating disorders and their relationship with menopausal phases among a sample of middle-aged Lebanese women. BMC Womens Health. 2022 May 10;22(1):153. doi: 10.1186/s12905-022-01738-6. PMID 35538474
• Kafaei-Atrian M, Sadat Z, Nasiri S, Izadi-Avanji FS. The Effect of Self-care Education Based on Self-efficacy Theory, Individual Empowerment Model, and Their Integration on Quality of Life among Menopausal Women. Int J Community Based Nurs Midwifery. 2022 Jan;10(1):54-63. doi: 10.30476/IJCBNM.2021.86814.1370. PMID 35005041
• Carr, A., Cullen, K., Keeney, C., Canning, C., Mooney, O., Chinseallaigh, E., & O'Dowd, A. (2021). Effectiveness of positive psychology interventions: A systematic review and meta-analysis. The Journal of Positive Psychology, 16(6), 749-769. https://doi.org/10.1080/17439760.2020.1818807

Идентификаторы

NCT: NCT07165964 · IRB00003099 JORDI GOL · CER032510

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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