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临床试验/NCT07229989
NCT07229989进行中(未招募)不适用

Effectiveness of a Pregnancy Care App on Maternal Knowledge and Anxiety in Pregnant Women: Quasi-Experimental Study

Lincoln University College Malaysia1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
1
主要终点
Change in maternal knowledge about pregnancy care

研究概览

简要总结

  1. Objective:

To evaluate the effectiveness of the Pregnancy Care mobile application in improving maternal knowledge and reducing anxiety in preparation for childbirth, through an educational and holistic therapy-based approach. 2. Key Questions:

  1. Can the Pregnancy Care app improve pregnant women's knowledge about pregnancy and childbirth preparation?
  2. Is the app effective in reducing anxiety levels among pregnant women before delivery?
  3. What are the changes in knowledge and anxiety levels before and after the intervention in the group using the app compared to the control group?
  4. Procedure:

This study uses a quasi-experimental design with a pre-test and post-test approach involving two groups:

  1. Intervention group: Participants will use the Pregnancy Care app for one week. The app includes educational content on physical and emotional changes during pregnancy, nutritional and activity needs, and childbirth preparation. It also features holistic therapy components such as antenatal yoga, acupressure, guided relaxation, meditation, self-hypnosis, mindfulness, deep breathing, journaling, and hope-based affirmations.
  2. Control group: Participants will receive standard education without using the app.

Measurements will be taken before and after the intervention using validated questionnaires to assess knowledge and anxiety levels. The data will be analyzed to determine the effectiveness of the app in enhancing maternal readiness for childbirth

详细描述

Background:

Anxiety before childbirth is a common issue among pregnant women and can negatively affect the delivery process and maternal-infant health. Adequate knowledge and psychological support are essential to help mothers feel more prepared and confident.

Study Purpose:

To develop and evaluate the Pregnancy Care mobile application as a digital intervention aimed at improving maternal knowledge and reducing anxiety through educational content and holistic therapy.

App Content: The Pregnancy Care app integrates:

研究设计

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

盲法说明

This study does not involve masking or blinding. All participants and investigators are aware of the group assignments and the intervention being used.

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant women aged 20-35 years
  • •Gestational age between 12 and 36 weeks
  • •Able to read and understand the language used in the PcyCare platform
  • •Owns a smartphone, tablet, or computer with internet access
  • •Provides informed consent to participate

排除标准

  • •High-risk pregnancy requiring intensive medical care
  • •Severe psychiatric or cognitive disorders that would prevent platform use
  • •Participation in another conflicting educational or intervention study

研究组 & 干预措施

Intervention Group

Experimental

Arm Type: Experimental Arm Name: Intervention Group Description: Participants in this group will use the Pregnancy Care mobile application for two week. The app includes educational content and holistic therapy features (yoga, acupressure, relaxation, journaling, etc.).

干预措施: PcyCare (Pregnancy Care) App (Behavioral)

control group

No Intervention

Arm Type: Active Comparator Arm Name: Control Group Description: Participants in this group will receive standard maternal education without using the mobile application.

结局指标

主要结局

Change in maternal knowledge about pregnancy care

时间窗: two weeks interventions

Maternal knowledge about pregnancy care will be evaluated as a primary outcome in this study. The assessment will utilize the PNOS (Pregnancy Knowledge Scale) questionnaire, a structured instrument consisting of 50 multiple-choice questions that cover essential topics such as nutrition during pregnancy, recognition of danger signs, antenatal care practices, and birth preparedness. Each correct answer is scored as 1, while incorrect answers receive a score of 0, resulting in a total score range of 0 to 50. Scores are categorized into three levels: 0-24 (low knowledge), 25-33 (moderate knowledge), and 34-50 (high knowledge). The questionnaire has been tested for validity, with a Pearson correlation coefficient (r) \> 0.361, indicating all items are valid. Reliability testing using Cronbach's Alpha yielded 0.917, confirming that the instrument is highly reliable.

次要结局

  • Change in maternal anxiety levels during pregnancy(Baseline and 2 weeks intervention)
  • Change in birth preparedness among pregnant women(2 weeks intervention)

研究者

发起方
Lincoln University College Malaysia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurul Jannah, M.Tr.Keb

Principle Investigator

Lincoln University College Malaysia

研究点 (1)

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