Digital Transformation in Infertility Treatment: Effectiveness and Future Potential of a Comprehensive Mobile Web Application (Infertilitech)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 148
- 主要终点
- Infertility Adjustment Scale
研究概览
简要总结
The primary objective of this project is to increase the treatment compliance and success of infertile couples based on the Knowledge-Motivation-Behavioral Skills model.
To develop a mobile web application and evaluate its effectiveness with scientific methods.
The secondary aim was to evaluate the effect of using a mobile application on Infertility Affect Status, Self-Efficacy, Infertility Adjustment and State-Trait Anxiety.
effect of the impact of the study.
详细描述
Infertility is a serious health problem affecting 8-12% of couples worldwide. This situation causes couples to face significant biopsychosocial and economic difficulties. Infertility process needs a multidisciplinary approach due to the diversity of etiological factors and complexity of treatment options. Especially in patriarchal societies, the problem of infertility may lead to negativities such as divorce, polygamy and social exclusion. In Turkey, the cultural importance of having children increases the psychological pressure on infertile couples. The coverage of infertility treatment by public institutions is limited. Therefore, couples often have to turn to the private sector and face high costs. Currently, infertile couples' sources of access to information are largely limited to the web pages of private infertility centres. In this context, the development of an evidence-based, reliable and free mobile web application for infertile couples emerges as a critical need. The main aim of this project is to develop a mobile web application to increase the treatment compliance and success of infertile couples and to evaluate its effectiveness with scientific methods. Original contributions are as follows:
- Creating a national comprehensive and culturally sensitive mobile web application different from the existing web pages on infertility. Regular updating and sharing of evidence-based medical and supportive treatment methods.
- Providing a structure that includes women as well as their husbands and family members in the process.
Inclusion of non-pharmacological methods (mindfulness etc.) in addition to medical treatments.
- Providing personalised information with the Ask Me module supported by artificial intelligence.
- R&D and scientific testing of the application with a randomised controlled trial.
In the second phase of the project, a randomised controlled study will be conducted with 74 individuals in the experimental group and 74 individuals in the control group who are treated in two infertility centres and who are determined by G-power. In the project, individuals in the experimental group will be asked to use the application for at least three months. Data will be collected using the Participant Information Form, measurement tools for infertility treatment compliance and success, and Mobile Application Evaluation Form. The user experience, interaction level and the effects of the application on increasing adherence to treatment will also be analysed. With the successful completion of the project, it is envisaged that a national mobile application will be created, the application will be translated into different languages to expand its usage area and economic sustainability will be ensured. In addition, it is planned to contribute to health policies in line with the scientific data obtained, to increase the effectiveness of digital health solutions for infertility and to facilitate access to health services.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be between the ages of 18-45,
- •Being diagnosed with primary infertility,
- •To be able to read, write and understand Turkish,
- •Not having a disability to use a smartphone,
- •Being at the stage of agreeing to start infertility treatment (initial period of treatment),
- •Using the mobile app at least 4 times a week for 15 minutes each for 3 months for partner
- •Volunteer to participate in the project,
- •Not having a disability to use a smartphone,
- •Using the mobile app at least 1 time/15 minutes per week for 3 months
排除标准
- •Incomplete answers to forms,
- •Not using the mobile app at all for a week,
- •Wanting to leave the study,
- •Voluntary discontinuation of infertility treatment for partner
- •Incomplete completion of the forms (uMARS and State-Trait Anxiety Inventory),
- •Not using the mobile app at all for two weeks
研究组 & 干预措施
ınfertilitech group
Before starting the project, the couples in the experimental group will be informed about the mobile application. The women will use the mobile application weekly for 3 months.
4 times for at least 15 minutes each. To create motivation for use, women in the experimental group will be asked to motivational notification will be sent via the mobile application.
干预措施: ınfertility group (Other)
control group
Women in the control group will not receive any intervention. After collecting the post-test data in the project, the principle of benefit and equality Taking this into account, women and their husbands participating in the control group will be given the opportunity to use the mobile application free of charge for three months.
干预措施: control group (Other)
结局指标
主要结局
Infertility Adjustment Scale
时间窗: three months
The Turkish validity and reliability of the scale developed by Glover et al. was analyzed by Arslan Özkan et al. was conducted. The scale is six-point Likert-type and consists of 12 items. The scale is only administered to women. Scores that can be obtained from the scale are 12-72 ranges between the two scales. Increasing scores on the scale indicate an increase in maladjustment to loss of fertility. Cronbach's alpha coefficient was determined as 0.77
次要结局
- Infertility Affect Scale(three months)
- Participant Information Form(three months)
- Infertility Self-Efficacy Scale-Short Form(three months)
- State-Trait Anxiety Inventory(three months)
- User Version of the Mobile Application Rating Scale(three months)