NCT07229989

Brief Summary

  1. 1.Objective:
  2. 2.Key Questions:
  3. 3.Can the Pregnancy Care app improve pregnant women's knowledge about pregnancy and childbirth preparation?
  4. 4.Is the app effective in reducing anxiety levels among pregnant women before delivery?
  5. 5.What are the changes in knowledge and anxiety levels before and after the intervention in the group using the app compared to the control group?
  6. 6.Procedure:
  7. 7.Intervention group: Participants will use the Pregnancy Care app for one week. The app includes educational content on physical and emotional changes during pregnancy, nutritional and activity needs, and childbirth preparation. It also features holistic therapy components such as antenatal yoga, acupressure, guided relaxation, meditation, self-hypnosis, mindfulness, deep breathing, journaling, and hope-based affirmations.
  8. 8.Control group: Participants will receive standard education without using the app.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2 days

First QC Date

September 29, 2025

Last Update Submit

January 12, 2026

Conditions

Keywords

antenatal carePrenatal educationDigital health intervention

Outcome Measures

Primary Outcomes (1)

  • Change in maternal knowledge about pregnancy care

    Maternal knowledge about pregnancy care will be evaluated as a primary outcome in this study. The assessment will utilize the Pregnancy Knowledge Questionnaire (TPKQ):, a structured instrument consisting of 10 multiple-choice questions that cover essential topics such as nutrition during pregnancy, recognition of danger signs, antenatal care practices, and birth preparedness. Each correct answer is scored as 1, while incorrect answers receive a score of 0, resulting in a total score range of 0 to 10. The questionnaire has been tested for validity, with a Pearson correlation coefficient (r) \> 0.361, indicating all items are valid. Reliability testing using Cronbach's Alpha yielded 0.81, confirming that the instrument is highly reliable.

    21 days interventions

Secondary Outcomes (2)

  • Change in maternal anxiety levels during pregnancy

    Baseline and 21 days intervention

  • Change in birth preparedness among pregnant women

    21 days intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Arm Type: Experimental Arm Name: Intervention Group Description: Participants in this group will use the pcycare digital for 21 day The app includes educational content and holistic therapy.

Behavioral: PcyCare (Pregnancy Care) App

control group

NO INTERVENTION

Arm Type: Active Comparator Arm Name: Control Group Description: Participants in this group will receive standard maternal education without using the mobile application.

Interventions

The Pregnancy Care App is a mobile-based self-learning platform designed to improve maternal knowledge and reduce anxiety before childbirth. It includes educational modules on pregnancy and labor preparation, as well as holistic therapy features such as antenatal yoga, acupressure, guided relaxation, meditation, self-hypnosis, mindfulness, deep breathing, journaling, and hope-based affirmations. Participants in the intervention group will use the app for two week.

Also known as: Mobile Health for Maternal Education, Digital Holistic Therapy for Pregnancy
Intervention Group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women aged 20-40 years
  • Gestational age between 28 and 35 weeks
  • Able to read and understand the language used in the PcyCare platform
  • Owns a smartphone, tablet, or computer with internet access
  • Provides informed consent to participate

You may not qualify if:

  • High-risk pregnancy requiring intensive medical care
  • Severe psychiatric or cognitive disorders that would prevent platform use
  • Participation in another conflicting educational or intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Disctrict

Semarang, Central Java, 50009, Indonesia

Location

MeSH Terms

Interventions

Prenatal CareAmyloidTelemedicinePregnancy

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsMaternal Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMultiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and ProteinsDelivery of Health CarePatient Care ManagementHealth Services AdministrationReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Nurul Jannah, M.Tr.Keb

    Lincoln University College Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
This study does not involve masking or blinding. All participants and investigators are aware of the group assignments and the intervention being used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study uses a quasi-experimental design with a pre-test and post-test approach. Participants are assigned to one of two groups: an intervention group using the Pregnancy Care app for 21 day, and a control group receiving standard education. The study aims to evaluate the app's effectiveness in improving maternal knowledge and reducing anxiety before childbirth.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 29, 2025

First Posted

November 17, 2025

Study Start

September 18, 2025

Primary Completion

September 20, 2025

Study Completion

December 30, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations