Trajectory of Psychological Distress Among Infertility Women

Taipei Medical University

Status: Enrolling

Conditions: Infertility; Heart Rate Variability; Biofeedback

Treatments: Behavioral: Web-based mind-body intervention; Behavioral: Web-based mind-body intervention with HRVB

Study type: Interventional

Funder types: Other

Identifiers

NCT04829877

N201807030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 3 patient groups

Web-based mind-body intervention with HRVB

Experimental group

Description:

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.

Treatment:

Behavioral: Web-based mind-body intervention with HRVB

Web-based mind-body intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Web-based mind-body intervention

Control

No Intervention group

Description:

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.