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

Study Overview

• Status: Completed
• Conditions: Anxiety; Pregnancy-Related Anxiety (PrA)
• Intervention / Treatment: Behavioral: PCYCARE Digital Self-Care Program; Other: Routine Antenatal Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Semarang, Central Java, Indonesia, 50009
      • Primary Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Arm Type: Experimental Arm Name: PCYCARE Intervention Group Description: Participants in this group receive the PCYCARE digital self-care program for 21 days. The program consists of two components: educational modules aimed at improving maternal knowledge and childbirth preparedness, and; guided audio relaxation sessions designed to support emotional regulation and improve sleep quality. Participants are instructed to complete two sessions per day (education and relaxation), each lasting approximately 10-15 minutes.	Behavioral: PCYCARE Digital Self-Care Program; PCYCARE is a mobile-based digital self-care intervention designed for third-trimester pregnant women. The program integrates two main components: (1) structured educational modules aimed at improving maternal knowledge and childbirth preparedness (cognitive and psychosocial domains), and (2) guided audio relaxation sessions designed to support emotional regulation and improve sleep quality (physiological domain). Participants are instructed to engage with the program twice daily for 21 days, completing both educational and relaxation sessions. Each session lasts approximately 10-15 minutes. The intervention is designed to support integrated biopsychosocial adaptation and reduce pregnancy-related anxiety.; Other Names: Pregnancy Care App; Digital Pregnancy Self-Care Intervention
Active Comparator: Routine Antenatal Care Group (control); Arm Type: Active Comparator Arm Name: Routine Antenatal Care Group Description: Participants in this group receive routine antenatal care without access to the PCYCARE digital intervention. Standard care includes regular antenatal check-ups, health education, and routine maternal monitoring according to local clinical guidelines.	Other: Routine Antenatal Care; Participants receive routine antenatal care according to local clinical practice guidelines. Standard care includes regular antenatal check-ups, basic maternal health education, and routine monitoring of pregnancy. No additional digital self-care intervention or structured program is provided during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pregnancy-Related Anxiety	Pregnancy-related anxiety is assessed using the Late Pregnancy Anxiety Scale-Indonesian Version (LPAS-ID), an 8-item Likert-type scale. Each item is rated on a 4-point scale, with higher total scores indicating greater levels of anxiety. The outcome is defined as the change in total score from baseline to post-intervention.	Baseline and 21 days (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sleep Quality	Sleep quality is assessed using the Maternal Sleep Quality Index for the Third Trimester - Indonesian Version (MSQI-T3-ID), an 8-item self-report instrument. Higher total scores indicate poorer sleep quality. The outcome is defined as the change in total score from baseline to post-intervention.	Baseline and 21 days (post-intervention)
Change in Maternal Knowledge	Maternal knowledge is assessed using the Third Trimester Pregnancy Knowledge Questionnaire (TPKQ), a 10-item multiple-choice instrument. Each correct response is scored as 1 and incorrect responses as 0, with higher scores indicating greater knowledge. The outcome is defined as the change in total score from baseline to post-intervention.	Baseline and 21 days (post-intervention)
Change in Childbirth Preparedness	Childbirth preparedness is assessed using the Childbirth Readiness Questionnaire (CRQ), a 9-item Likert-type scale. Higher total scores indicate greater preparedness for childbirth. The outcome is defined as the change in total score from baseline to post-intervention.	Baseline and 21 days (post-intervention)

Collaborators and Investigators

• Sponsor: Lincoln University College Malaysia
• Investigators: Principal Investigator: Nurul Jannah, M.Tr.Keb, Lincoln University College Malaysia

Publications and helpful links

General Publications

• Jannah, N., & Selvarajh, G. (2026). Late-pregnancy anxiety as a distinct multidimensional construct: Psychometric evidence from a community-based sample. Science Midwifery, 13(6), 1562-1570
• Jannah, N., Selvarajh, G., & Lestari, S. (2025). Feasibility and Acceptability of PcyCare: A Self-Directed Digital Platform for Maternal Health Literacy and Emotional Support. International Journal of Nursing Information, 4(2), 12-22.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2025
• Primary Completion (Actual): September 20, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sleep quality; mobile health (mHealth); biopsychosocial model; pregnancy-related anxiety; digital self-care intervention; maternal knowledge; childbirth preparedness
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Health Services Administration; Delivery of Health Care; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Macromolecular Substances; Multiprotein Complexes; Patient Care Management; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Maternal Health Services; Amyloid; Telemedicine; Prenatal Care; Pregnancy
• Other Study ID Numbers: LUC_02_Jannah (Other Identifier: Lincoln University College Malaysia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) collected during this study will not be shared with other researchers outside the study team. This decision is based on considerations of participant confidentiality, ethical approval limitations, and the scope of the current research. All data will be used solely for the purposes of this study and will remain under the control of the principal investigator and affiliated institution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No