Pregnancy Care Digital Intervention for Maternal Anxiety in the Third Trimester (PCYCARE-RCT)

Effectiveness of a Pregnancy Care Digital Self-Care Intervention on Maternal Anxiety in the Third Trimester Within a Biopsychosocial Adaptation Framework: A Randomized Controlled Trial

The goal of this clinical trial is to evaluate whether a digital self-care intervention (PCYCARE) can reduce pregnancy-related anxiety and improve biopsychosocial adaptation among third-trimester pregnant women.

The main questions it aims to answer are:

1. Does the PCYCARE digital program reduce pregnancy-related anxiety in third-trimester pregnant women?
2. Does the intervention improve maternal knowledge, childbirth preparedness, and sleep quality?

Researchers will compare participants who receive the PCYCARE digital program with those who receive routine antenatal care to determine the effectiveness of the intervention.

Participants will:

1. Use the PCYCARE mobile-based program for 21 days, which includes educational modules and guided audio relaxation sessions
2. Complete two sessions per day (education and relaxation), each lasting approximately 10-15 minutes
3. Complete questionnaires at baseline and after the intervention to assess anxiety, sleep quality, maternal knowledge, and childbirth preparedness

Background:

Pregnancy-related anxiety is a common psychological condition during the third trimester and is associated with adverse maternal and neonatal outcomes, including preterm birth, shortened gestation, and impaired maternal-infant adaptation. Unlike generalized anxiety, pregnancy-related anxiety reflects condition-specific concerns related to fetal health, childbirth, and readiness for motherhood. Emerging evidence indicates that pregnancy-related anxiety is influenced by interconnected cognitive, psychosocial, and physiological mechanisms. Maternal knowledge contributes to cognitive appraisal and perceived control, childbirth preparedness reflects psychosocial readiness, and sleep quality represents a key physiological regulator of emotional stability. These domains interact dynamically, suggesting that pregnancy-related anxiety can be understood as a biopsychosocial adaptation process. Despite increasing use of digital health interventions in maternal care, many existing applications focus on single outcomes and lack theoretical integration across these domains. Therefore, there is a need for structured digital interventions that simultaneously address cognitive, psychosocial, and physiological pathways.

Intervention Overview:

This study evaluates PCYCARE, a digital self-care program designed to support integrated maternal adaptation during late pregnancy. The intervention consists of:

1. educational modules aimed at improving maternal knowledge and childbirth preparedness (cognitive and psychosocial domains), and
2. guided audio relaxation sessions aimed at supporting emotional regulation and improving sleep quality (physiological domain).

Participants are instructed to complete two sessions per day (education and relaxation), each lasting approximately 10-15 minutes, over a 21-day intervention period.

Study Objectives:

The primary objective of this study is to evaluate the effectiveness of the PCYCARE digital intervention in reducing pregnancy-related anxiety among third-trimester pregnant women.

Secondary objectives are to evaluate improvements in maternal knowledge, childbirth preparedness, and sleep quality, and to examine how these variables interact within a biopsychosocial adaptation model.

Study Design:

This study employs an individual randomized controlled trial (RCT) with a pretest-posttest design. Participants are randomly assigned in a 1:1 ratio to either the intervention group or the control group using stratified block randomization.

Study Population:

The study population consists of primigravida women in the third trimester of pregnancy (28-35 weeks of gestation) recruited from primary health centers.

Comparator:

Participants in the control group receive routine antenatal care without access to the PCYCARE digital intervention.

Outcomes and Biopsychosocial Model:

The study includes four key measured variables:

1. Pregnancy-related anxiety (primary outcome)
2. Sleep quality (secondary outcome; physiological domain)
3. Maternal knowledge (secondary outcome; cognitive domain)
4. Childbirth preparedness (secondary outcome; psychosocial domain)

All variables are measured at baseline and after the 21-day intervention using validated instruments.

This study is guided by a digital biopsychosocial adaptation model in which:

1. Cognitive adaptation (maternal knowledge) enhances understanding and perceived control
2. Psychosocial adaptation (childbirth preparedness) supports readiness and coping
3. Physiological regulation (sleep quality) stabilizes emotional responses

Within this model, sleep quality is hypothesized to function as a central pathway linking cognitive and psychosocial improvements to reductions in pregnancy-related anxiety.

Significance:

This study provides evidence for a theory-driven digital self-care intervention that integrates cognitive, psychosocial, and physiological mechanisms. The findings are expected to inform scalable strategies for improving maternal mental health and childbirth preparedness, particularly in resource-limited settings.

Inclusion Criteria:

1. Pregnant women aged 20-35 years
2. Gestational age between 28 and 35 weeks (third trimester)
3. Primigravida
4. Able to read and understand the language used in the PCYCARE platform
5. Owns a smartphone or digital device with internet access
6. Willing to participate and provide informed consent

Exclusion Criteria:

1. High-risk pregnancy requiring intensive medical care
2. Severe psychiatric or cognitive disorders that may interfere with participation
3. Participation in another intervention or educational program that may affect study outcomes