Trajectory of Psychological Distress Among Infertility Women
NCT ID: NCT04829877
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
750 participants
INTERVENTIONAL
2022-04-19
2025-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Web-based mind-body intervention with HRVB
Both 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 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.
Web-based mind-body intervention
Both 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.
Web-based mind-body intervention
The web-based mind-body intervention will receive 5 different topics courses.
Control
The 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.
No interventions assigned to this group
Interventions
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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.
Web-based mind-body intervention
The web-based mind-body intervention will receive 5 different topics courses.
Eligibility Criteria
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Inclusion Criteria
* Seeking infertility care
* Contemplating pregnancy
* Intended to start their ART cycle
* Able to speak Taiwanese or Mandarin
Exclusion Criteria
* Already had started their ART treatment
* Taking medications that might affect ANS activity
20 Years
60 Years
FEMALE
Yes
Sponsors
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Taipei Medical University
OTHER
Responsible Party
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Shu Yu Kuo
Principal investigator
Principal Investigators
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Shu-Yu Kuo, Phd
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University
Locations
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Infertility clinic
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Jin-Ru Chang, BS
Role: primary
Other Identifiers
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N201807030
Identifier Type: -
Identifier Source: org_study_id
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