Trajectory of Psychological Distress Among Infertility Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-60
SponsorTaipei Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
20-year-old and above
Seeking infertility care
Contemplating pregnancy
Intended to start their ART cycle
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Web-based mind-body intervention with HRVB
BehavioralThe 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
BehavioralThe web-based mind-body intervention will receive 5 different topics courses.
Treatment groups
750 Participants
are divided into 3 treatment groupsGroup A: Web-based mind-body intervention with HRVBExperimental treatment 1 intervention
Group B: Web-based mind-body interventionExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Time frame
Baseline2
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Time frame
1 week post-intervention3
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Time frame
1 month post-intervention4
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Time frame
2 month post-interventionSecondary outcomes
1
Depressive symptoms
The Taiwanese version of the Beck Depression Inventory (BDI) will be used to assess depressive symptoms among infertility women.
Time frame
Baseline, post-intervention 1 week, month 1 , 2 and 32
HRV function
The HRV signal will be measured using standard equipment.
Time frame
Baseline, post-intervention 1 week, month 1 , 2 and 33
Mindful awareness
The Taiwanese version of the Five Facet Mindfulness Questionnaire (FFMQ) will be adopted to assess levels of mindfulness.
Time frame
Baseline, post-intervention 1 week, month 1 , 2 and 34
Infertility self-efficacy
The infertility Self-Efficacy Scale (ISE) will be used for studied women.
Time frame
Baseline, post-intervention 1 week, month 1 , 2 and 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov