Trajectory of Psychological Distress Among Infertility Women
Recruiting now · Not applicable
Conditions studied: Infertility, Heart Rate Variability, Biofeedback
In brief
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.
Key facts
- Study ID
- NCT04829877
- Run by
- Taipei Medical University
- People needed
- 750
- Starts
- 2022-04-19
- Expected to finish
- 2025-04-01
- Last updated by the study team
- 2025-01-27
Who can join
Age: 20 and older, up to 60. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 20-year-old and above
- Seeking infertility care
- Contemplating pregnancy
- Intended to start their ART cycle
- Able to speak Taiwanese or Mandarin
You may not qualify if…
- Diagnosis of cardiovascular disease, depressive disorder, anxiety disorder, cardiac arrhythmia
- Already had started their ART treatment
- Taking medications that might affect ANS activity
Where it is running
- Infertility clinic — Taipei, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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