Feasibility Study of PcyCare (Pregnancy Care) : A Self-Learning Educational Platform for Pregnant Women
Phase: NA
Conditions: Pregnancy
Sponsor: Nurul Jannah, M.Tr.Keb

STUDY PROTOCOL WITH STATISTICAL ANALYSIS PLAN  
AND INFORMED CONSENT FORM 
 
Title 
: Feasibility Study of PcyCare (Pregnancy Care) : A Self-
Learning Educational Platform for Pregnant Women 
Document Date 
: September 11, 2025 
Sponsor 
: Nurul Jannah, B.Med., M.Tr.Keb., M.Psi 
Principal Investigator 
: Nurul Jannah, B.Med., M.Tr.Keb., M.Psi 
Affiliation 
Location 
: 
: 
Lincoln University College Malaysia 
Disctrict, Semarang, JAWA TENGAH 50009, INDONESIA 
 
1. Study Overview 
a. Brief Title 
: Feasibility Study of PcyCare (Pregnancy Care) : A Self-
Learning Educational Platform for Pregnant Women 
b. Acronym 
: PcyCare (Pregnancy Care) 
c. Study Type 
: Interventional 
d. Official Title 
: Feasibility Study of PcyCare (Pregnancy Care) : A Self-
Learning Educational Platform for Pregnant Women 
e. Other Identifier 
: LUC20230708005 
f. Issuing Organization : Lincoln University College Malaysia 
 
2. Study Descriptio 
a. Brief Summary  
1) Objective: 
This study aims to evaluate the feasibility and usefulness of the PcyCare self-
directed education platform for pregnant women. This platform provides 
information on nutrition, pregnancy warning signs, mental health, and childbirth 
preparation. 
2) Key questions: 
a) Is PcyCare easy to use for pregnant women? 
b) Do the platform's materials and features help improve participants' 
understanding of pregnancy and childbirth? 

c) How do subject matter experts and information technology experts assess the 
quality of the platform's content and features? 
3) Procedure: 
Pregnant women will use PcyCare for one week, accessing educational materials, 
watching videos, and completing interactive quizzes. Their understanding and 
experience will be evaluated through feasibility and satisfaction questionnaires. 
Content experts (midwifery lecturers/practicing midwives) and media/IT experts 
will assess the suitability of the platform's content and features through expert 
reviews and provide suggestions for improvement. Expected results: Information 
about ease of use, content quality, effectiveness of interactive features, and input 
from experts to refine the platform before wider trials. 
 
b. Detailed Description 
The PcyCare platform was developed as a self-directed educational medium for 
pregnant women, with the aim of improving understanding of nutrition, pregnancy 
warning signs, mental health, and childbirth preparation. This study aims to evaluate 
the feasibility, ease of use, and content quality of the platform prior to wider 
implementation, while also obtaining input from experts for platform refinement. This 
study involved 10 pregnant women as primary users. During the one-week study 
period, participants accessed the platform via smartphone or computer, read 
educational materials, watched interactive videos, and completed quizzes. 
Researchers collected data through feasibility and satisfaction questionnaires and 
assessed participants' understanding before and after using the platform. This activity 
aimed to determine whether the platform was easy to use and could improve pregnant 
women's understanding. 
In addition, the study also involved 8 subject matter experts (midwifery 
lecturers/practicing midwives) and 5 information technology/media experts as 
evaluators of the platform's content and features. The experts assessed the scientific 
accuracy, completeness of the material, language, cultural appropriateness, visual 
quality, and interactivity of the platform using a special assessment instrument (expert 
review). Input from experts will be used to improve and refine the platform before it 
is tested more widely. The results of the study are expected to provide information on 
ease of use, content quality, effectiveness of interactive features, and 
recommendations for improvement from experts. This study will serve as a basis for 

improving the feasibility and quality of PcyCare, so that the platform can be used as 
an effective and safe self-education medium for pregnant women at various 
educational and socio-cultural levels. 
c. Conditions or Focus of Study 
1) Feasibility study of digital health intervention in antenatal care 
2) Self-learning educational platform for pregnant women 
d. Keywords  
1) Pregnancy care 
2) Prenatal education 
3) Self-learning platform 
4) Feasibility study 
5) Digital health intervention 
 
3. Study Design 
a. Primary Purpose  
: Device Feasibility 
b. Study Phase   
: N/A 
c. Interventional Study Model 
: Single group 
d. Model Description  
 
: Participants will use the PcyCare self-learning 
educational platform for one week. There is no 
randomization, crossover, or control group. The 
study aims to evaluate the feasibility, usability, 
and content quality of the platform based on 
feedback from pregnant women as primary 
users and expert reviewers, including maternal 
health specialists and IT/media experts. 
e. Number Arm 
: 1 
f. Masking : 
: None (Open Label) 
g. Masking Description : 
: Not applicable. This study does not involve 
masking or blinding as all participants and 
expert reviewers are aware of the intervention. 
h. Allocation 
: N/A 
i. Number of Participants 
: 10 
 
 
 

4. Arms and Interventions 
a. Arm Experimental  
1) Experimental : PcyCare (Pregnancy Care) Users 
2) Arm 
Description 
: Participants in this arm, consisting of pregnant women, used the 
PcyCare self-directed education platform for one week. 
Participants accessed educational modules covering nutrition, 
pregnancy warning signs, mental health, and childbirth 
preparation. This intervention included interactive content, 
instructional videos, and quizzes. Data on ease of use, 
participant satisfaction, and increased understanding were 
collected through questionnaires. In addition, input from expert 
assessors in the fields of obstetrics and information technology 
will be used to assess the quality of the content and the 
suitability of the platform. 
 
b. Intervention Device 
1) Device 
: PcyCare: Self-Directed Education Platform for Pregnant 
Women 
2) Other Names  
a. PcyCare Self-Learning Educational Platform 
b. Digital Pregnancy Care Platform 
3) Description 
: This intervention involves the use of the PcyCare self-directed 
education platform by pregnant women for one week. 
Participants will access educational modules on nutrition, 
pregnancy warning signs, mental health, and childbirth 
preparation. The platform includes interactive content, 
instructional videos, and quizzes to enhance participants' 
understanding. Data on ease of use, satisfaction, and increased 
understanding will be collected through questionnaires. In 
addition, midwives/practicing midwives and information 
technology/media experts will assess the quality of the 
platform's content and features through expert reviews to 
evaluate the platform's suitability and improvements before 
wider trials. 

 
5. Outcome Measures 
a. Primary outcome measures 
1) Outcome 
: Usability of PcyCare Platform 
2) Description 
: Assessment of the ease of use of the PcyCare platform by 
pregnant women, including module navigation, interactivity, 
and access to materials. Data was collected through a 
questionnaire on suitability and user experience. 
3) Time Frame 
: 1 weeks after initial use of the PcyCare platform 
 
b. Secondary outcome measures 
1) Outcome 
: Expert Review Evaluation of PcyCare Platform 
2) Description 
: Assessment of feasibility, content quality, and platform features 
by 8 subject matter experts (midwifery lecturers/practicing 
midwives) and 5 information technology/media experts using 
expert review instruments. These results were used to refine the 
platform prior to wider implementation 
3) Time Frame 
: Performed immediately after the platform is tested by experts 
(1 week) 
 
6. Eligibility 
a. Accepts Healthy Volunteers : Yes 
b. Sex 
: Female 
c. Gender Eligibility 
Description 
: Pregnant  women (Female) 
d. Age Limits 
: 20 – 30 Years 
e. Inclusion Criteria 
: 
1) Pregnant women aged 20–35 years 
2) Gestational age between 12 and 36 weeks 
3) Able to read and understand the language used 
in the PcyCare platform 
4) Owns a smartphone, tablet, or computer with 
internet access 
5) Provides informed consent to participate 

f. Exclusion Criteria 
: 
1) High-risk 
pregnancy 
requiring 
intensive 
medical care 
2) Severe psychiatric or cognitive disorders that 
would prevent platform use 
3) Participation 
in 
another 
conflicting 
educational or intervention study 
 
7. Statistical Analysis Plan (SAP) and Data Analysis 
1) Design & Data 
a. One-group pre–post feasibility study. 
b. Data: quantitative (questionnaire scores, usage logs) and qualitative (participant & 
expert comments). 
2) Participant Characteristics 
a. Age, education, gestational age, parity. 
b. Analysis: mean ± SD or median (IQR) and frequency (%). 
3) Feasibility 
a. Recruitment rate invited 
b. Completion rate: participants who completed all modules. Target ≥80%. 
c. Engagement: login duration & number of modules completed (mean ± SD). 
4) Content Validity (Expert)/ Content Validity Index (CVI) 
a. I-CVI per item ≥0.78. 
b. S-CVI/Ave ≥0.9. 
5) Qualitative Data 
Thematic analysis of participant/expert comments (point: ease of access, appearance, 
relevance of material). 
6) Software 
a. SPSS for quantitative data. 
b. NVivo for qualitative data. 
 
 

INFORMED CONSENT FORM 
 
Research Title 
: Feasibility Study of PcyCare (Pregnancy Care): A Self-Learning 
Educational Platform for Pregnant Women 
Research Objectives 
: You are invited to participate in a study evaluating PcyCare, a 
digital self-learning educational platform for pregnant women. 
The objective of this study is to assess the feasibility and ease of 
use of PcyCare in improving knowledge, self-care, and confidence 
during pregnancy. 
Procedure 
: If you agree to participate, you will: 
1. Complete an initial questionnaire about the ease of use of 
PcyCare as a self-care tool for mothers during pregnancy. 
2. Use 
the 
PcyCare 
module 
on 
your 
device 
(smartphone/computer) for 1 week. 
3. Complete a final questionnaire after use and provide 
feedback on your experience. 
Risks 
: 
1. Minimal risk: possibility of mild fatigue when filling out the 
questionnaire. 
2. No medical procedures or invasive procedures. 
Benefits 
: 
1. You will gain increased knowledge and self-care skills 
during pregnancy. 
2. The results of this study may help develop digital education 
services that are beneficial for pregnant women in the 
future. 
Confidentiality 
: All data will be stored with an identity code, without including 
personal names. Data will only be used for research purposes and 
protected in accordance with applicable ethical and regulatory 
requirements. 
Voluntary 
Participation 
 
Your participation is entirely voluntary. You may refuse or 
withdraw from participation at any time without any consequences 
Researcher Contact 
: Nurul Jannah, M.Psi 
Phone 
: +6289631376237 
Email 
: Jannah14hoci@gmail.com  
Consent 
By signing below, I declare that I have read and understood the explanation of this research, 
had the opportunity to ask questions, and am willing to participate. 
Participant  Name                               Signature                                       Date 
        _________________                          __________                            _____________