MedTrace Logo

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

NCT07229989 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-07

No results posted yet for this study

Summary

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

Conditions

  • Pregnancy-Related Anxiety (PrA)
  • Anxiety

Interventions

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

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.

Sponsors & Collaborators

  • Lincoln University College Malaysia

    lead OTHER

Principal Investigators

  • Nurul Jannah, M.Tr.Keb · Lincoln University College Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-18
Primary Completion
2025-09-20
Completion
2025-12-30

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07229989 on ClinicalTrials.gov