Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 2
- 主要终点
- Differences in the Screen IVF questionaire between the intervention groups
研究概览
简要总结
Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.
详细描述
About 8% of all couples of reproductive age are involuntary childless, and just about 25,000 couples receive a medical treatment each year in Germany, which is experienced as "roller coaster of emotions". The positive effect of "face-to-face" counseling for couples with a desire for children has been proven. However, this does not yet apply to a variety of other forms of intervention, e.g. telephone or online counseling.
In this study, the effectiveness of a smartphone-supported psychosocial intervention for women and men in reproductive treatment will be examined in a randomized controlled pre-post design.
For this purpose, an intervention group and a comparison intervention group of each n = 60 couples in reproductive treatment will be examined at two points during a four-week interval using the ScreenIVF questionaire. The ScreenIVF will be completed paper-pencil before the intervention and online after the intervention. In the fourteen-day waiting period between oocyte puncture and pregnancy test (or the reappearance of menstruation), both groups receive either positive adjustment techniques or brainteasers.In addition, both groups are questioned one month after the post-measurement date on the perceived effectiveness and practicability of the intervention techniques.
Sociodemographic variables (such as age, education) and medical data (such as diagnosis, previous treatment cycles) as potential moderators, as well as possible pregnancies at the second measurement time will be reported.
No adverse effects or other risks are expected for the study participants.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All couples undergoing infertility treatment (in vitro fertilization or intracytoplasmic sperm injection) at the Department of Gynecologic Endocrinology and Fertility Disorders at Heidelberg University Women's Hospital, which have
- •agreed to participate in the study
- •indicated their mobile phone number
- •sufficient knowledge of German language.
- •If one partner is refusing to participate, the other person may be admitted as an individual.
排除标准
- •denial of participation
- •non-existent smartphone
- •insufficient knowledge of German language
结局指标
主要结局
Differences in the Screen IVF questionaire between the intervention groups
时间窗: through study completion, an average of 2 years
Differences in the ScreenIVF risk profile at post-measurement time between the intervention group of positive adjustment and the intervention comparison group with the brainteasers
次要结局
- Qualitative evaluation of participants' opinion about the intervention(through study completion, an average of 2 years)
- Quantitative evaluation of participants' opinion about the intervention(through study completion, an average of 2 years)
研究者
Maren Schick
Principal Investigator
University Hospital Heidelberg
