Trajectory of Psychological Distress Among Infertility Women

April 12, 2023 updated by: Shu Yu Kuo, Taipei Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 110
        • Recruiting
        • Infertility clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
Behavioral: Web-based mind-body intervention
The web-based mind-body intervention will receive 5 different topics courses.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Baseline
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Baseline
Anxiety
Time Frame: 1 week post-intervention
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
1 week post-intervention
Anxiety
Time Frame: 1 month post-intervention
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
1 month post-intervention
Anxiety
Time Frame: 2 month post-intervention
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
2 month post-intervention
Anxiety
Time Frame: 3 month post-intervention
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
3 month post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: Baseline, post-intervention 1 week, month 1 , 2 and 3
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
HRV function
Time Frame: Baseline, post-intervention 1 week, month 1 , 2 and 3
The HRV signal will be measured using standard equipment.
Baseline, post-intervention 1 week, month 1 , 2 and 3
Mindful awareness
Time Frame: Baseline, post-intervention 1 week, month 1 , 2 and 3
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
Infertility self-efficacy
Time Frame: Baseline, post-intervention 1 week, month 1 , 2 and 3
The infertility Self-Efficacy Scale (ISE) will be used for studied women.
Baseline, post-intervention 1 week, month 1 , 2 and 3
Pregnancy rates
Time Frame: 15 days after embryo transfer or ultrasound
Clinical pregnancy will be defined as a positive blood, urinary pregnancy test.
15 days after embryo transfer or ultrasound

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201807030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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