跳至主要内容
临床试验/NCT07165964
NCT07165964招募中不适用

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

University of Barcelona2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年7月31日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
2
主要终点
Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
42 Years 至 58 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Climateric Intevention Group (IG)

Active Comparator

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.

干预措施: Personal interventions in Climateric (Behavioral)

Control Group (CG)

No Intervention

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.

结局指标

主要结局

Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale

时间窗: 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.

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marta Prats Arimon

Co-Investigador

University of Barcelona

研究点 (2)

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