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

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05024227
Collaborator
Cheng-Hsin General Hospital (Other)
100
1
2
10
10

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Experimental: nursing education interventions (including e-health platform assistance)
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Discussion on the Effect of Nursing Education Intervention on Women's Health Literacy of Plasticizers
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: nursing education interventions

nursing education interventions (including e-health platform assistance)

Behavioral: Experimental: nursing education interventions (including e-health platform assistance)
Nursing education intervention: Researchers use teaching, consultation and other methods to give individual cases planned learning to meet individual needs, providing 1. What is an environmental hormone-plasticizer; 2. Common types of environmental hormones (such as plasticizers) and Uses 3. Environmental hormones-sources of plasticizers 4. Environmental hormones-plasticizers harm to the human body 5. How to avoid the common environmental hormones-plasticizers and other related health education in life, and use the electronic platform to assist nursing education conduct.

No Intervention: No Intervention: Routine care

Only the original form of nursing education leaflets are given

Outcome Measures

Primary Outcome Measures

  1. Basic Demographic Health Assessment Form [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.

  2. .The Environmental Hormone-Plasticizer Health Literacy Scale [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.

  3. The Environmental Hormone-Plasticizer Health Literacy Scale [three month after intervention(T1)]

    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.

  4. The Environmental Hormone-Plasticizer Health Literacy Scale [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.

Secondary Outcome Measures

  1. The System Usability Scale [six month after intervention(T2)] for Experimental arm]

    System Usability Scale ( SUS) has ten items, created by John Brooke in 1986 (Brooke, 1986), and is widely used to quickly test standardized questionnaires (objectivity, universality, Repeatable and quantifiable) (Brooke, 2013). Using Likert's five-point scale, questions 1, 3, 5, 7, and 9 are positive questions, and questions 2, 4, 6, 8, and 10 are negative questions. After calculating the scores for each question, multiply all the scores by 2.5 to get the total score.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • (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.
Exclusion Criteria:
  • (1) Diagnosed with mental illness, (2) Cognitive impairment, (3) Under 20 years old, (4) Male.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cheng Hsin General Hospital Taipei Taipei City Taiwan 11219

Sponsors and Collaborators

  • National Taipei University of Nursing and Health Sciences
  • Cheng-Hsin General Hospital

Investigators

  • Study Director: Chia-Jung Hsieh, PhD, National Taipei University of Nursing and Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chia Jung Hsieh, PhD, RN, Associate Professor, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier:
NCT05024227
Other Study ID Numbers:
  • CHGH-IRB:(864)110-10
First Posted:
Aug 27, 2021
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chia Jung Hsieh, PhD, RN, Associate Professor, National Taipei University of Nursing and Health Sciences

Study Results

No Results Posted as of Feb 21, 2022