Trajectory of Psychological Distress Among Infertility Women
1 other identifier
interventional
750
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2021
CompletedFirst Posted
Study publicly available on registry
April 2, 2021
CompletedStudy Start
First participant enrolled
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedJanuary 27, 2025
January 1, 2025
3 years
March 31, 2021
January 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Baseline
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
1 week post-intervention
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
1 month post-intervention
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
2 month post-intervention
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
3 month post-intervention
Secondary Outcomes (5)
Depressive symptoms
Baseline, post-intervention 1 week, month 1 , 2 and 3
HRV function
Baseline, post-intervention 1 week, month 1 , 2 and 3
Mindful awareness
Baseline, post-intervention 1 week, month 1 , 2 and 3
Infertility self-efficacy
Baseline, post-intervention 1 week, month 1 , 2 and 3
Pregnancy rates
15 days after embryo transfer or ultrasound
Study Arms (3)
Web-based mind-body intervention with HRVB
EXPERIMENTALBoth standard usual care and the web-based mind-body intervention with HRV biofeedback (MBI-HRVB) will be provided to the participants. The web-based mind-body intervention with HRV biofeedback program consisted of 5-week training sessions and breathing training.
Web-based mind-body intervention
EXPERIMENTALBoth standard usual care and the web-based mind-body intervention will be provided to the participants. The web-based mind-body intervention program consisted of 5-week training sessions.
Control
NO INTERVENTIONThe women in the control group will receive the standard usual care provided at the fertility clinic. The standard care protocols encompass elements such as routine assessment and health education at each visit. Participants enrolled in the control group will be approached once a week by a nurse to provide health consultation about fertility treatment, medication, signs, and symptoms of discomfort for five weeks.
Interventions
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.
The web-based mind-body intervention will receive 5 different topics courses.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Infertility clinic
Taipei, 110, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shu-Yu Kuo, Phd
Taipei Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 31, 2021
First Posted
April 2, 2021
Study Start
April 19, 2022
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
January 27, 2025
Record last verified: 2025-01