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RECRUITING
NCT04829877
NA

Trajectory of Psychological Distress Among Infertility Women

Sponsor: Taipei Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

20 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2022-04-19

Completion Date

2025-04

Last Updated

2025-01-27

Healthy Volunteers

Yes

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.

Locations (1)

Infertility clinic

Taipei, Taiwan