Web-based mind-body intervention for women facing infertility
Trajectory of Psychological Distress Among Infertility Women: Efficacy and Mechanism of Mind-body Intervention With Heart Rate Variability Biofeedback
This study is testing a web-based program that helps women dealing with infertility manage stress and improve their emotional well-being to see if it can also boost their chances of getting pregnant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | Female |
| Sponsor | Taipei Medical University Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT04829877 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a web-based mind-body intervention that incorporates heart rate variability biofeedback to alleviate psychological distress in women experiencing infertility. The trial will recruit eligible participants who are seeking infertility care and randomize them into different intervention groups. The primary outcomes include anxiety symptoms, depression levels, heart rate variability function, mindful awareness, infertility self-efficacy, and pregnancy rates. Data quality will be maintained through a designed data entry system and appropriate statistical analyses will be conducted to ensure reliable results.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20 and above who are seeking infertility care and contemplating pregnancy.
Not a fit: Patients with cardiovascular disease, depressive or anxiety disorders, or those already undergoing assisted reproductive technology treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce psychological distress and improve pregnancy outcomes for women undergoing fertility treatments.
How similar studies have performed: Other studies have shown promise in using mind-body interventions for psychological distress in infertility, but this specific approach combining HRV biofeedback is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taipei
- Infertility clinic — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Shu-Yu Kuo, Phd — Taipei Medical University
- Study coordinator: Shu-Yu Kuo, Phd
- Email: sykuo@tmu.edu.tw
- Phone: +886-2-2736-1661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.