Clinical trial NCT04829877: Trajectory of Psychological Distress Among Infertility Women
Official title: Trajectory of Psychological Distress Among Infertility Women: Efficacy and Mechanism of Mind-body Intervention With Heart Rate Variability Biofeedback
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Heart Rate Variability
Biofeedback
Keywords: infertility
mind-body intervention
heart rate variability
biofeedback
psychological distress
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 750
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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

Primary outcomes:
measure: Anxiety
timeFrame: Baseline
measure: Anxiety
timeFrame: 1 week post-intervention
measure: Anxiety
timeFrame: 1 month post-intervention
measure: Anxiety
timeFrame: 2 month post-intervention
measure: Anxiety
timeFrame: 3 month post-intervention
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Baseline, post-intervention 1 week, month 1 , 2 and 3
measure: HRV function
timeFrame: Baseline, post-intervention 1 week, month 1 , 2 and 3
measure: Mindful awareness
timeFrame: Baseline, post-intervention 1 week, month 1 , 2 and 3
measure: Infertility self-efficacy
timeFrame: Baseline, post-intervention 1 week, month 1 , 2 and 3
measure: Pregnancy rates
timeFrame: 15 days after embryo transfer or ultrasound
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Infertility clinic
Study officials:
affiliation: Taipei Medical University
name: Shu-Yu Kuo, Phd
role: PRINCIPAL_INVESTIGATOR
References: