The Effect of Web-Based Support Program on Psychosocial Health Status in Women With Unsuccessful IVF Experience
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Depression (Beck Depression Inventory)
研究概览
简要总结
The goal of this interventional study is to learn if web-based support program can improve the psychosocial health status in women with unsuccessful IVF experience. The main questions it aims to answer are:
Does web-based support decrease the depressive symptoms, anxiety and infertility-related stress? Does web-based support decrease the hopelessness? Does web-based support increase the coping skills with infertility-related stress?
Researchers will compare this intervention to a control group to see if web-based support program improves psychosocial health.
Participants will:
Use the web-based support intervention for 5 weeks or have no intervention. Complete the surveys on the website before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having at least three repeated unsuccessful IVF experiences,
- •Maximum one month has passed since the negative IVF experience,
- •Participating in the study voluntarily,
- •Being able to read, understand and communicate in Turkish.
排除标准
- •Not having access to the internet/not knowing how to use it,
- •Having any psychiatric disease/being in the 'severe depression' grade as a result of the Beck Depression Inventory,
- •Having at least one living child.
- •Exclusion criteria from the study in the stages after including the study:
- •Spontaneous pregnancy occurring,
- •Starting a new treatment cycle,
- •Not continuing to monitor the modules on the website.
结局指标
主要结局
Depression (Beck Depression Inventory)
时间窗: 24 months
Beck Depression Inventory (BDI) will be used to evaluate the participants' anxiety outcome. This inventory, whose validity and reliability in Turkish was studied by Hisli (1989), consists of a total of 21 items and four interpreted sub-dimensions. The scoring of the scale is a four-point Likert type (0 = positive statements about depression; 3 = negative statements about depression). The total score that can be obtained from the scale varies between 0-63; 0-9 points indicate minimal depression, 10-16 points indicate mild depression, 17-29 points indicate moderate depression, and 30-63 points indicate severe depression.
Infertility-related stress (The Infertility Stress Scale)
时间窗: 24 months
The Infertility Stress Scale will be used to assess participants' infertility-related stress. Schmidt (2006) developed this scale in 1996. In our country, the validity and reliability of the scale was studied by Şahin Yılmaz (2012). This scale is a scale with a total of 14 items consisting of three sub-dimensions and answers are given in a Lykert type. Calculations per subdimensions requires a special formula for each subdimension. An increase in score is interpreted as an increase in stress.
Coping Skills with Infertility Stress (Coping with Infertility Stress Scale)
时间窗: 24 months
Coping with Infertility Stress Scale: Developed by Schmidt (2006) in 1996. In our country, the validity and reliability of the scale was studied by Şahin Yılmaz (2012). This scale is a scale with a total of 19 items consisting of four sub-dimensions. e Active-Struggle Coping, Passive-Struggle Coping, Passive-Ignoring Coping and Meaning-Based Coping Method. Each subscale score can be calculated seperately.
次要结局
- Effect of the Web-based study program(24 months)
- Hopelessness(24 months)
研究者
Elif Balkan
PhD Student
Istanbul University - Cerrahpasa