Trajectory of Psychological Distress Among Infertility Women

Официальное название

Trajectory of Psychological Distress Among Infertility Women: Efficacy and Mechanism of Mind-body Intervention With Heart Rate Variability Biofeedback

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Web-based mind-body intervention with HRVB
  The web-based mind-body intervention with HRVB contains the following components: 1) Breathing training with HRV biofeedback; 2) 5 different topics will be included ; 3) Home exercise of slow breathing and mindfulness exercise.
• Поведенческое Web-based mind-body intervention
  The web-based mind-body intervention will receive 5 different topics courses.

Первичные конечные точки

• Anxiety [Срок оценки: Baseline]
• Anxiety [Срок оценки: 1 week post-intervention]
• Anxiety [Срок оценки: 1 month post-intervention]
• Anxiety [Срок оценки: 2 month post-intervention]
• Anxiety [Срок оценки: 3 month post-intervention]

Вторичные конечные точки (5)

• Depressive symptoms [Срок оценки: Baseline, post-intervention 1 week, month 1 , 2 and 3]
• HRV function [Срок оценки: Baseline, post-intervention 1 week, month 1 , 2 and 3]
• Mindful awareness [Срок оценки: Baseline, post-intervention 1 week, month 1 , 2 and 3]
• Infertility self-efficacy [Срок оценки: Baseline, post-intervention 1 week, month 1 , 2 and 3]
• Pregnancy rates [Срок оценки: 15 days after embryo transfer or ultrasound]

Критерии участия

Критерии включения

• 20-year-old and above
• Seeking infertility care
• Contemplating pregnancy
• Intended to start their ART cycle
• Able to speak Taiwanese or Mandarin

Критерии исключения

• Diagnosis of cardiovascular disease, depressive disorder, anxiety disorder, cardiac arrhythmia
• Already had started their ART treatment
• Taking medications that might affect ANS activity

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Тайвань · 1 центр

• Infertility clinic — Taipei

Идентификаторы

NCT: NCT04829877 · N201807030

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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