RecruitingNot ApplicableNCT04829877

Trajectory of Psychological Distress Among Infertility Women

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


Sponsor

Taipei Medical University

Enrollment

750 participants

Start Date

Apr 19, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 60 Years

Inclusion Criteria5

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

Exclusion Criteria3

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

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Interventions

BEHAVIORALWeb-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.

BEHAVIORALWeb-based mind-body intervention

The web-based mind-body intervention will receive 5 different topics courses.


Locations(1)

Infertility clinic

Taipei, Taiwan

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NCT04829877


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