跳至主要内容
临床试验/NCT05024227
NCT05024227Unknown不适用

Discussion on the Effect of Nursing Education Intervention on Women's Health Literacy of Plasticizers

National Taipei University of Nursing and Health Sciences2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Basic Demographic Health Assessment Form

研究概览

简要总结

Environmental hormone (environmental hormone), also known as "endocrine disrupting chemicals" (EDCS), is a pollutant that affects the endocrine system and causes diseases and dysfunction throughout the life cycle. Many daily products are ubiquitous, and the most common are phthalates (plasticizers); in recent years, many scientific research reports have determined the adverse health effects of phthalates, including: Infertility (Den Hond et al. al., 2015), testicular hypoplasia (Fisher, 2004), obesity (Dirtu et al., 2013), diabetes (Fénichel & Chevalier, 2017), hyperglycemia (Williams et al., 2016), asthma (Wang et al., 2016) al., 2015), endometriosis and high abortion rate (Roy et al., 2015), polycystic ovary syndrome (Vagi et al., 2014), prostate cancer (Chuang et al., 2020), and Breast cancer (Chen et al., 2020; Fu et al., 2017; Holmes et al., 2014; López-Carrillo et al., 2010), etc. In 2011, the Taiwan Food and Drug Administration detected di(2-ethylhexyl)phthalate (DEHP) and dibutyl phthalate (DBP) in foods, food supplements, and beverages, and determined that the Taiwanese population has a high content of phthalates (Yang et al., 2013). It pointed out that exposure to plasticizers in the uterus will have lifelong effects and even endanger the health of the next generation, indicating that there is a significant positive correlation between the concentration of metabolites in the urine of pregnant women and the urine of their children (Lin et al., 2011; Wu et al., 2013), even related to children's autism (Carter & Blizard, 2016; Rossignol et al., 2014).

However, so far there is still a lack of research on environmental hormone-plasticizers to improve health literacy or develop interventional research. Therefore, this study hopes to track the health literacy of their plasticizers and provide nursing education interventions (including e-health platform assistance) for women. Randomized controlled trials (English: randomized controlled trial, RCT) will be used to test nursing education interventions using a double-blind trial system. (Including e-health platform assistance) Effectiveness, in order to provide simple and fast self-health monitoring and management for the people, and it is expected that the case can early prevent the occurrence of related diseases and ensure the safety of the living environment.

详细描述

Environmental hormone (environmental hormone), also known as "endocrine disrupting chemicals" (EDCS), is a pollutant that affects the endocrine system and causes diseases and dysfunction throughout the life cycle. Many daily products are ubiquitous, and the most common are phthalates (plasticizers); in recent years, many scientific research reports have determined the adverse health effects of phthalates, including: Infertility (Den Hond et al. al., 2015), testicular hypoplasia (Fisher, 2004), obesity (Dirtu et al., 2013), diabetes (Fénichel & Chevalier, 2017), hyperglycemia (Williams et al., 2016), asthma (Wang et al., 2016) al., 2015), endometriosis and high abortion rate (Roy et al., 2015), polycystic ovary syndrome (Vagi et al., 2014), prostate cancer (Chuang et al., 2020), and Breast cancer (Chen et al., 2020; Fu et al., 2017; Holmes et al., 2014; López-Carrillo et al., 2010), etc. In 2011, the Taiwan Food and Drug Administration detected DEHP and DBP in foods, food supplements, and beverages, and determined that the Taiwanese population has a high content of phthalates (Yang et al., 2013). It pointed out that exposure to plasticizers in the uterus will have lifelong effects and even endanger the health of the next generation, indicating that there is a significant positive correlation between the concentration of metabolites in the urine of pregnant women and the urine of their children (Lin et al., 2011; Wu et al., 2013), even related to children's autism (Carter & Blizard, 2016; Rossignol et al., 2014).

Health literacy is an important factor in determining public and personal health, and is regarded as the core of patient-centered care. Relevant studies have indicated that a lack of health literacy has the following results: higher mortality, poor self-management skills, lower satisfaction with medical and disease communication, poor awareness of diseases, higher hospitalization and emergency medical use rates, easier incorrect medication, low utilization of preventive health care services (such as screening), high prevalence of chronic diseases (such as cardiovascular disease, diabetes, and obesity, etc.), and high health care costs (Berkman, Sheridan, Donahue, Halpern, & Crotty, 2011; Berkman, Sheridan, Donahue, Halpern, Viera, et al., 2011; DeWalt et al., 2004). However, so far there is still a lack of research on environmental hormone-plasticizers to improve health literacy or develop interventional research. Therefore, this study hopes to track the health literacy of their plasticizers and provide nursing education interventions (including e-health platform assistance) for women. Randomized controlled trials (RCT) will be used to test nursing education interventions using a double-blind trial system. (Including e-health platform assistance) Effectiveness, in order to provide simple and fast self-health monitoring and management for the people, and it is expected that the case can early prevent the occurrence of related diseases and ensure the safety of the living environment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • (1) Females who are 20 years or older (inclusive); (2) Clear consciousness and no mental disorders; (3) Those who can communicate with others in Mandarin or Taiwanese, are willing to participate in this research after explanation, and sign the consent form.

排除标准

  • (1) Diagnosed with mental illness, (2) Cognitive impairment, (3) Under 20 years old, (4) Male.

结局指标

主要结局

Basic Demographic Health Assessment Form

时间窗: baseline, pre-intervention(T0)

Number, age, gender, marriage, current living area, height, weight, blood pressure, pulse, waist circumference, BMI, education level, past medical history, work-related, living habits, weight control, eating habits; B. Emotional state; C. Female Related questions: menstrual history, fertility status, medication, supplement status, disease history, etc.

The Environmental Hormone-Plasticizer Health Literacy Scale

时间窗: six month after intervention(T2)

It is divided into three areas of environmental hormone health literacy: Health care, Disease prevention and Health promotion. The answers are based on a Likert 4-point scale, ranging from "very difficult" (1) to "very easy" (4). A higher total score, indicates better environmental hormone-plasticizer health literacy. The total score range is 0-40.

.The Environmental Hormone-Plasticizer Health Literacy Scale

时间窗: baseline, pre-intervention(T0)

It is divided into three areas of environmental hormone health literacy: Health care, Disease prevention and Health promotion. The answers are based on a Likert 4-point scale, ranging from "very difficult" (1) to "very easy" (4). A higher total score, indicates better environmental hormone-plasticizer health literacy. The total score range is 0-40.

次要结局

  • The System Usability Scale(six month after intervention(T2)] for Experimental arm)

研究者

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

Chia Jung Hsieh

PhD, RN, Associate Professor

National Taipei University of Nursing and Health Sciences

研究点 (2)

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