Trajectory of Psychological Distress Among Infertility Women

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04829877
• Other study ID #: N201807030
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: January 2024

Study information

• Verified date: April 2023
• Source: Taipei Medical University
• Contact: Shu-Yu Kuo, Phd
• Phone: +886-2-2736-1661
• Email: sykuo[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A designed data entry system for the current study will be developed to ensure an error-proof process. It is important to inspect data for outliers, wild code, and consistency to maintain the data quality in the pre-analysis data phase. We will assess the amount and pattern of missing values by using descriptive statistics, such as frequency and percentage. The pattern of missing data will be identified and decide whether the missing completely at random or not. The appropriate corresponding method will be adopted for the subsequent statistical analyses. For example, the mean imputation is considered when the percentage of items missing at a given questionnaire is less than 10 %. The mean imputation will be used to replaces a missing value with the item mean when applicable. The comparison between complete case analysis and imputation data will be performed to assess the reliability and validity of the results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Biofeedback
• Heart Rate Variability
• Infertility

Intervention

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

Locations

Country	Name	City	State
Taiwan	Infertility clinic	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).	Baseline
Primary	Anxiety	Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).	1 week post-intervention
Primary	Anxiety	Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).	1 month post-intervention
Primary	Anxiety	Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).	2 month post-intervention
Primary	Anxiety	Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).	3 month post-intervention
Secondary	Depressive symptoms	The Taiwanese version of the Beck Depression Inventory (BDI) will be used to assess depressive symptoms among infertility women.	Baseline, post-intervention 1 week, month 1 , 2 and 3
Secondary	HRV function	The HRV signal will be measured using standard equipment.	Baseline, post-intervention 1 week, month 1 , 2 and 3
Secondary	Mindful awareness	The Taiwanese version of the Five Facet Mindfulness Questionnaire (FFMQ) will be adopted to assess levels of mindfulness.	Baseline, post-intervention 1 week, month 1 , 2 and 3
Secondary	Infertility self-efficacy	The infertility Self-Efficacy Scale (ISE) will be used for studied women.	Baseline, post-intervention 1 week, month 1 , 2 and 3
Secondary	Pregnancy rates	Clinical pregnancy will be defined as a positive blood, urinary pregnancy test.	15 days after embryo transfer or ultrasound