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

April 1, 2026 updated by: Nurul Jannah, M.Tr.Keb, Lincoln University College Malaysia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  1. educational modules aimed at improving maternal knowledge and childbirth preparedness, and
  2. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pregnancy-Related Anxiety
Time Frame: Baseline and 21 days (post-intervention)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Sleep Quality
Time Frame: Baseline and 21 days (post-intervention)
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
Time Frame: Baseline and 21 days (post-intervention)
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
Time Frame: Baseline and 21 days (post-intervention)
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lincoln University College Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nurul Jannah, M.Tr.Keb, Lincoln University College Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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