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临床试验/NCT07564856
NCT07564856已完成不适用

A Climate-Related Nursing Intervention to Improve Knowledge, Health Beliefs, and Protective Behaviors in Women With Preeclampsia: A Randomized Controlled Trial

Benha University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
1
主要终点
Pregnancy-Specific Climate Change Knowledge

研究概览

简要总结

This randomized controlled trial aims to evaluate the effectiveness of a climate-related nursing intervention in improving pregnancy-specific climate change knowledge, health beliefs, and protective behaviors among pregnant women diagnosed with preeclampsia. Climate change, particularly extreme heat exposure and air pollution, increases maternal and fetal health risks and may worsen hypertensive disorders of pregnancy such as preeclampsia. Despite growing evidence linking climate-related exposures to adverse pregnancy outcomes, there is limited intervention research addressing climate adaptation in high-risk pregnant women.

A total of 104 pregnant women with preeclampsia receiving antenatal care at Benha University Hospitals, Egypt, were randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group received routine antenatal care plus a structured nursing educational program entitled "Climate-Safe Pregnancy: Adaptation and Self-Protection Guidelines for Women with Preeclampsia," while the control group received routine antenatal care alone.

The intervention included an individualized core educational session, structured educational materials, and a booster follow-up session. Outcomes were assessed at baseline, post-intervention, and follow-up using the Pregnancy-Specific Climate Change Awareness Scale (PSCCAS), the Health Belief Model-Based Climate Change and Preeclampsia Scale (HBM-CCP), and the Climate Change Health Protection Behaviors Scale (CCHPB).

The study aims to provide evidence for theory-based nursing interventions that support maternal adaptation to climate-related health risks and improve antenatal care outcomes for women with preeclampsia.

详细描述

This study is a two-arm, parallel-group randomized controlled trial conducted to evaluate the effectiveness of a structured climate-related nursing intervention for pregnant women diagnosed with preeclampsia. The study was conducted at the antenatal outpatient clinic of Benha University Hospitals, Egypt, between July and December 2025. Preeclampsia is a major hypertensive disorder of pregnancy associated with significant maternal and fetal morbidity. Climate-related exposures such as extreme heat, dehydration, air pollution, and environmental stressors may further increase maternal vulnerability and worsen pregnancy outcomes. Despite growing evidence linking climate change to adverse obstetric outcomes, there is limited intervention research addressing climate adaptation among women with preeclampsia, particularly in low- and middle-income countries.

A total of 104 eligible pregnant women diagnosed with preeclampsia were recruited and randomly allocated in a 1:1 ratio into intervention and control groups using computer-generated block randomization with sealed opaque envelope allocation concealment. The intervention group received routine antenatal care in addition to a structured nursing intervention entitled "Climate-Safe Pregnancy: Adaptation and Self-Protection Guidelines for Women with Preeclampsia." The intervention included an individualized 45-minute core educational session covering climate-related maternal risks, protective behaviors, problem-solving strategies, and self-efficacy enhancement, followed by structured educational materials and a booster reinforcement session delivered after 10 days.

The control group received routine antenatal care only, including standard monitoring, medication management, and routine counseling regarding preeclampsia and antenatal follow-up. The primary outcome was pregnancy-specific climate change knowledge measured using the Pregnancy-Specific Climate Change Awareness Scale (PSCCAS). Secondary outcomes included climate-related health beliefs measured using the Health Belief Model-Based Climate Change and Preeclampsia Scale (HBM-CCP), and climate change health protection behaviors measured using the Climate Change Health Protection Behaviors Scale (CCHPB).

Outcome measures were assessed at baseline, post-intervention, and four-week follow-up. The study aimed to generate evidence for theory-based nursing interventions that improve maternal adaptation to climate-related health risks and strengthen antenatal care outcomes for women with preeclampsia.

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
None

盲法说明

This study was conducted as an open-label trial. Due to the nature of the educational nursing intervention, blinding of participants, care providers, and investigators was not feasible.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women diagnosed with mild or moderate preeclampsia
  • Gestational age between 20 and 34 weeks
  • Age between 18 and 45 years
  • Singleton pregnancy
  • Able to read and communicate effectively
  • Willing to participate and provide informed consent

排除标准

  • Severe preeclampsia requiring immediate hospitalization
  • Presence of chronic medical disorders such as renal disease, cardiac disease, or autoimmune disorders
  • Multiple pregnancy
  • Diagnosed psychiatric illness or cognitive impairment affecting participation
  • Participation in another structured educational intervention during the study period

研究组 & 干预措施

Control Group

Active Comparator

Participants receive routine antenatal care only, including standard monitoring, medication management, and routine counseling regarding preeclampsia and antenatal follow-up.

干预措施: Routine Antenatal Care (Other)

Intervention

Experimental

Participants receive routine antenatal care plus a structured climate-related nursing intervention entitled "Climate-Safe Pregnancy: Adaptation and Self-Protection Guidelines for Women with Preeclampsia," including an individualized educational session, structured educational materials, and a booster follow-up session.

干预措施: Climate-Related Nursing Intervention (Behavioral)

结局指标

主要结局

Pregnancy-Specific Climate Change Knowledge

时间窗: Baseline, 2 weeks post-intervention, and 4 weeks follow-up

Pregnancy-specific climate change knowledge measured using the Pregnancy-Specific Climate Change Awareness Scale (PSCCAS), a 21-item validated instrument assessing general climate change awareness, maternal health awareness, and fetal health awareness. Higher scores indicate greater awareness and knowledge regarding climate-related maternal and fetal risks.

次要结局

  • Climate-Related Health Beliefs(Baseline, 2 weeks post-intervention, and 4 weeks follow-up)
  • Climate Change Health Protection Behaviors(Baseline, 2 weeks post-intervention, and 4 weeks follow-up)

研究者

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

Eman Atef Elsokary

Assistant professor of Maternal and Newborn Health Nursing

Benha University

研究点 (1)

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