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
Phase: NA
Conditions: Pregnancy-Related Anxiety (PrA), Anxiety
Sponsor: Lincoln University College Malaysia

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Study Protocol with Informed Consent Form 
 
Official Title: 
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 
 
ClinicalTrials.gov Identifier: 
NCT07229989 
 
Document Type: 
Study Protocol with Informed Consent Form 
 
Date: 
August 26, 2025 
 
Principal Investigator: 
Nurul Jannah, M.Tr.Keb., M.Psi 
 
Institution: 
Lincoln University College Malaysia 
 

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Study Identification 
1. Organization's Unique 
Protocol ID 
: LUC_02_Jannah 
2. Brief Title 
: Pregnancy Care Digital Intervention for Maternal Anxiety in 
the Third Trimester (PCYCARE-RCT) 
3. Acronym 
: PCYCARE-RCT 
4. Study Type 
: Interventional 
5. Official Title 
: 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 
6. Secondary ID 
: LUC_02_Jannah 
7. Issuing Organization 
: Lincoln University College Malaysia 
8. Address 
: Jl. Tirto Agung, Pedalangan, Banyumanik, Semarang, 
Central Java, Indonesia 
 
Data Monitoring 
1. Data Monitoring 
Committee 
: No 
2. Record Verification Date 
: March 2026 
3. Overall Recruitment Status 
: Completed 
4. Study Start Date 
: September 18, 2025 (Actual) 
5. Primary Completion Date 
: September 20, 2025 (Actual) 
6. Study Completion Date 
: December 30, 2025 (Actual) 
 
Sponsors and Collaborators 
1. Responsible Party 
: Principal Investigator 
2. Investigator Name 
: Nurul Jannah, M.Tr.Keb 
3. Investigator Username 
: njannah 
4. Investigator Official Title 
: Principal Investigator 
5. Investigator Affiliation 
: Lincoln University College Malaysia 
6. Sponsor 
: Lincoln University College Malaysia 
 
Oversight 
1. FDA-Regulated Drug 
: No 
2. FDA-Regulated Device 
: No 
3. IND/IDE 
: No 
 
Ethics Approval 
1. Board Status 
: Approved 
2. Approval Number 
: 1111/EA/F.XXIII.38/2025 
3. Board Name 
: Health Research Ethics Committee, Ministry of Health, 
Semarang Health Polytechnic 
4. Board Affiliation 
: Ministry of Health, Semarang Health Polytechnic 
5. Board Contact 
 
Tel: 024–7460274; Email: kepk@poltekkes-smg.ac.id 
 
 
 

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Brief 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 
 
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 

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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 responsesWithin 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. 
 
Condition and Keyword 
Section 
Item 
Description 
Conditions / Focus of Study Primary Condition 
Pregnancy-Related Anxiety (PrA) 
 
Additional Condition Third Trimester Pregnancy 
Additional Condition Maternal Anxiety 
Keywords 
Keyword 1 
pregnancy-related anxiety 
Keyword 2 
digital self-care intervention 
Keyword 3 
maternal knowledge 
Keyword 4 
childbirth preparedness 
Keyword 5 
sleep quality 
Keyword 6 
biopsychosocial model 
Keyword 7 
third trimester pregnancy 
Keyword 8 
mobile health (mHealth) 
 
Study Design 
Primary Purpose 
: Treatment 
Study Phase 
: N/A 
Interventional 
Model 
: Parallel Assignment 
Model 
Description 
: This study is an individual randomized controlled trial (RCT) with a 
pretest–posttest design. Participants are randomly assigned in a 1:1 ratio 
using stratified block randomization into two parallel groups: an 
intervention group receiving the PCYCARE digital self-care program 
for 21 days, and a control group receiving routine antenatal care. The 
study evaluates the effectiveness of the intervention in improving 
maternal knowledge, childbirth preparedness, sleep quality, and 
reducing pregnancy-related anxiety. 
Number of Arms 
: 2 
Masking 
: None (Open Label) 

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Masking 
Description 
: This is an open-label study. Due to the nature of the digital intervention, 
participants and investigators are aware of group assignments. 
Standardized outcome measures are used to minimize measurement 
bias. 
Allocation 
: Randomized 
Enrollment 
: 120 (Actual) 
 
 
Arms and Interventions 
Arms 
Interventions 
Experimental : Intervention GroupArm 
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 
ProgramPCYCARE 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 Name: 
1. Pregnancy Care App 
2. 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 CareParticipants 
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.Other Name: 
 
 

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OUTCOME MEASURES 
PRIMARY OUTCOME MEASURE 
Outcome 
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 
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) 
 
Eligibility 
1. Accepts Healthy 
Volunteers 
: No 
2. Sex 
: Female 
3. Gender Based 
: No 
4. Minimum Age 
: 20 Years 
5. Maximum Age 
: 35 Years 
6. Eligibility Criteria 
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  

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(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 
 
CONTACT 
1. Central Contact 
Person 
Nurul Jannah • +6289631376237 jannah14hoci@gmail.com 
2. Central Contact 
Backup 
Gunavathy J Selvarajh +0 0 gunavathy@lincoln.edu.my 
3. Study Officials 
Nurul Jannah Lincoln University College Malaysia Principal 
Investigator 
 
LOCATION 
Indonesia Primary Health Centers (Puskesmas) in Semarang Regency SEMARANG, JAWA 
TENGAH, Indonesia 50009 Principal Investigator: Nurul NJ Jannah 
 
IPD SHARING STATEMENT 
1. Plan to 
Share IPD 
: No 
2. 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. 
 
REFERENCE 
Citation 
Description 
1. 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.  
https://doi.org/10.58418/ijni.v4i2.168 
This study evaluates the feasibility and 
acceptability of PCYCARE, a self-
directed digital platform designed to 
improve maternal health literacy and 
provide 
emotional 
support 
during 
pregnancy. 
2. 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.  
https://doi.org/10.35335/midwifery.v13i6.2230 
Pregnancy-related anxiety is assessed 
using the LPAS-ID, an 8-item Likert 
scale (1–4). Higher total scores indicate 
greater anxiety. The outcome is defined 
as the change in total score from baseline 
to post-intervention. 
 

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INFORMED CONSENT FORM 
 
Study Title 
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 
 
Clinical Trial Registration 
ClinicalTrials.gov Identifier: NCT07229989 
 
Principal Investigator 
Nurul Jannah, M.Tr.Keb. 
Lincoln University College Malaysia 
Phone: +6289631376237 
Email: jannah14hoci@gmail.com 
 
Background of the Study 
Pregnancy-related anxiety during the third trimester is a common condition associated with 
adverse maternal and neonatal outcomes, including preterm birth and impaired maternal–infant 
adaptation. This condition reflects specific concerns related to fetal health, childbirth, and 
readiness for motherhood. This study evaluates a digital self-care intervention (PCYCARE) 
designed to improve maternal adaptation through a biopsychosocial framework, integrating 
cognitive (maternal knowledge), psychosocial (childbirth preparedness), and physiological 
(sleep quality) components. 
 
Purpose of the Study 
The purpose of this study is to: 
1. Evaluate whether the PCYCARE digital intervention reduces pregnancy-related 
anxiety  
2. Assess improvements in sleep quality  
3. Assess improvements in maternal knowledge  
4. Assess improvements in childbirth preparedness  
 
 

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Risks and Discomforts 
This study involves minimal risk. Possible discomforts include: 
• 
Mild fatigue when completing questionnaires  
• 
Minor discomfort during relaxation sessions  
There are no invasive procedures or medical risks involved. 
 
Potential Benefits 
Participation may provide the following benefits: 
• 
Reduction in pregnancy-related anxiety  
• 
Improved sleep quality  
• 
Increased knowledge about pregnancy  
• 
Better preparedness for childbirth  
 
Confidentiality 
All collected data will be treated confidentially: 
• 
Personal identifiers will be removed or coded  
• 
Data will be securely stored  
• 
Results will be reported in aggregate form without identifying participants  
 
Data Use and Privacy 
Your data will be used only for research purposes related to this study. Data will not be shared 
outside the research team and will remain under the control of the principal investigator. 
 
Voluntary Participation 
Your participation is entirely voluntary. You have the right to: 
• 
Refuse to participate  
• 
Withdraw at any time without any consequences or impact on your healthcare services  
 
Contact for Questions 
If you have questions or concerns about this study, please contact: 
Nurul Jannah 
Phone: +6289631376237 
Email: jannah14hoci@gmail.com 
 

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PARTICIPANT CONSENT 
I have read and understood the information provided above. I have had the opportunity to ask 
questions, and all my questions have been answered satisfactorily. 
I voluntarily agree to participate in this study. 
 
Participant Name 
: ___________________________ 
Signature 
 
: ___________________________ 
Date 
 
 
: ___________________________ 
 
INVESTIGATOR STATEMENT 
I confirm that I have explained the purpose, procedures, risks, and benefits of this study to the 
participant and answered all questions. 
 
Investigator Name 
: ___________________________ 
Signature 
 
: ___________________________ 
Date 
 
 
: ___________________________