Trajectory of Psychological Distress Among Infertility Women: Efficacy and Mechanism of Mind-body Intervention With Heart Rate Variability Biofeedback
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
Background: Infertility is a serious reproductive health issue and affects 48.5 million couples worldwide. Women undergoing fertility treatment often experienced psychological distress but also social stigma that is close linked to later pregnancy outcome. Despite the advancement in assisted reproductive technology, effective interventions for reducing stress, anxiety, and depressive symptoms for infertility women remain lacking.
Objectives: The objective of this proposal is to evaluate the efficacy of web-based mind-body intervention combining HRV biofeedback on the infertility women's anxiety symptoms, levels of depression, HRV function, mindful awareness, infertility self-efficacy, and pregnancy rates.
Methods: We plan to conduct a randomized controlled trial on the web-based mind-body intervention combining heart rate variability biofeedback. Eligible women will be recruited and randomized into three groups. Intention-to-treat analysis and mixed regression modeling will be used to estimate the effectiveness of the interventions.
Anticipatory results: Effective strategies will be determined for infertility women.
详细描述
A designed data entry system for the current study will be developed to ensure an error-proof process. It is important to inspect data for outliers, wild code, and consistency to maintain the data quality in the pre-analysis data phase. We will assess the amount and pattern of missing values by using descriptive statistics, such as frequency and percentage. The pattern of missing data will be identified and decide whether the missing completely at random or not. The appropriate corresponding method will be adopted for the subsequent statistical analyses. For example, the mean imputation is considered when the percentage of items missing at a given questionnaire is less than 10 %. The mean imputation will be used to replaces a missing value with the item mean when applicable. The comparison between complete case analysis and imputation data will be performed to assess the reliability and validity of the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •20-year-old and above
- •Seeking infertility care
- •Contemplating pregnancy
- •Intended to start their ART cycle
- •Able to speak Taiwanese or Mandarin
排除标准
- •Diagnosis of cardiovascular disease, depressive disorder, anxiety disorder, cardiac arrhythmia
- •Already had started their ART treatment
- •Taking medications that might affect ANS activity
结局指标
主要结局
Anxiety
时间窗: 3 month post-intervention
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
次要结局
- Infertility self-efficacy(Baseline, post-intervention 1 week, month 1 , 2 and 3)
- Mindful awareness(Baseline, post-intervention 1 week, month 1 , 2 and 3)
- HRV function(Baseline, post-intervention 1 week, month 1 , 2 and 3)
- Depressive symptoms(Baseline, post-intervention 1 week, month 1 , 2 and 3)
- Pregnancy rates(15 days after embryo transfer or ultrasound)
研究者
Shu Yu Kuo
Principal investigator
Taipei Medical University