Trajectory of Psychological Distress Among Infertility Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Web-based mind-body intervention with HRVB, Web-based mind-body intervention.
- Who it may be relevant to
- Registry conditions: Infertility, Heart Rate Variability, Biofeedback. Basic parameters: 20 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Trajectory of Psychological Distress Among Infertility Women: Efficacy and Mechanism of Mind-body Intervention With Heart Rate Variability Biofeedback
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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. - Behavioral Web-based mind-body intervention
The web-based mind-body intervention will receive 5 different topics courses.
Primary outcome measures
- Anxiety [Time frame: Baseline]
- Anxiety [Time frame: 1 week post-intervention]
- Anxiety [Time frame: 1 month post-intervention]
- Anxiety [Time frame: 2 month post-intervention]
- Anxiety [Time frame: 3 month post-intervention]
Secondary outcome measures (5)
- Depressive symptoms [Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3]
- HRV function [Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3]
- Mindful awareness [Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3]
- Infertility self-efficacy [Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3]
- Pregnancy rates [Time frame: 15 days after embryo transfer or ultrasound]
Eligibility criteria
Inclusion criteria
- 20-year-old and above
- Seeking infertility care
- Contemplating pregnancy
- Intended to start their ART cycle
- Able to speak Taiwanese or Mandarin
Exclusion criteria
- Diagnosis of cardiovascular disease, depressive disorder, anxiety disorder, cardiac arrhythmia
- Already had started their ART treatment
- Taking medications that might affect ANS activity
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Taiwan · 1 center
- Infertility clinic — Taipei
Identifiers
NCT: NCT04829877 · N201807030