Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06192381 |
| Other study ID # |
No.P.0360 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 11, 2022 |
| Est. completion date |
May 25, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Umm Al-Qura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Polycystic ovary syndrome (PCOS) is a heterogeneous endocrinopathy among
reproductive-aged women that has become a major international public health concern.
Objective: Investigate the effect of web-based health education module on nursing students'
knowledge, adaptive healthy measures and attitude regarding polycystic ovary syndrome.
Research design: A two-armed, single-blind, parallel groups prospective randomized controlled
trial (RCT), with a baseline pre-test and immediate post-test was used to carry out this
study. Setting: The study was conducted at the Faculty of Nursing, Mansoura University, Egypt
in December 2022 to May 2023. Subjects and sampling: Simple random sampling technique was
employed to recruit the study subjects. Data collection: A questionnaire was developed to
acquire data including six parts.
Description:
Pre-intervention phase:
Initial data was gathered about the participants' socio-demographic characteristics, their
knowledge, adaptive healthy measures, and attitude toward PCOS before the implementation of
the health education intervention. A brief introduction to the goals, processes, voluntary
nature of participation, confidentiality and anonymity declarations, and questionnaire cover
page were all included. Participants were made aware that they could withdraw from the study
at any moment, there would be no negative repercussions, and they could choose to have any
case data acquired for the study destroyed. The informed consent form must be signed by the
participants and submitted back by ordinary mail to participate.
The developed health education module was created based on the participants' preliminary
assessment results and according to recommendations from [30]. It consisted of seven
interactive modules (4 hours' sessions) in Arabic that covered the following topics:
"overview of PCOS, etiology and risk factors, signs and symptoms, diagnosis, complications,
preventive measures, and treatment of PCOS." It aimed at increasing health awareness
regarding PCOS, encouraging and promoting adaptive healthy measures to prevent PCOS, and
promoting a positive attitude regarding PCOS.
The module development team gathered to discuss how each module would be prepared and
formatted, as well as how the modules' sessions would be broken down. The program was
designed with a defined purpose, precise goals, pertinent materials, and instructional
techniques. In addition, it was developed to provide easy access to web-based education that
incorporates sources to increase knowledge and support healthy measures and a positive
attitude regarding PCOS. This is done using a set of technical and instructional standards
developed by a web-based design team and an information technology expert. The researchers
provided the web designer with word-processed documents representing each distinct learning
session, videos, a storyboard of suggested graphics, and a description of interactions.
The development team met once a week to go over any issues that might occur with the module,
to offer ideas and comments where appropriate, and to address any queries that might have
come up while each session was being developed. The web-based design team and researchers
chose a learning platform that gave users access to data, tools, and resources to support the
administration and delivery of education about PCOS and associated preventive actions online.
To get rid of Wix's pop-up advertisements, the researchers bought a distinctive website
domain URL.
The site map and links to the tutorials, forums, and other resources are all accessible from
the main screen. The web-based module also included a chat room where students and students
conducting research could post questions and engage in conversation. To get user feedback on
the learning experience and improve the interface, post-learning discussions and comments
were created. Additionally, each student's frequency and amount of time spent were noted.
To make it simple for the user to choose another menu, the primary menu is also continuously
shown on the upper bar. No session could be skipped because the navigation was sequential
from session 1 to session 7. The intervention group participants could move on to the
following screen, replay the current screen, or go back to the previous screen at any time
during a session. They were given as much time as they needed to consider the data displayed
on each screen.
The researchers developed the content of the web-based health education sessions. Besides,
they drew lines between the elements to indicate how they were linked together. These lines
helped dictate sessions' organization, navigation, and hyperlinks. Moreover, it was arranged
into seven sessions. It was displayed by using text, pictures, and videos.
The content was uploaded to the website by the researchers and professional programmers
(https://healthconcerns.tech/). The link to the website was distributed to a panel of five
external reviewers (experts in community health nursing, women's health and midwifery
nursing, and professional programmers) to systematically test the content's validity,
clarity, consistency, accuracy, applicability, and format before the application of the
web-based education module. Any specific guidelines or suggestions from the experts'
evaluation were recorded and considered while creating the web-based teaching sessions. The
traditional training session that was given to the control group's students' material was the
same.
The face validity of the web-based modules was assessed concurrently with the review process
using a sample group of students (n = 14) who had no prior knowledge of PCOS to assess the
clarity, applicability, and reliability of the module and to determine the approximate time
needed to implement these sessions. Each student in the intervention group completed a module
each week and gave the content producer detailed comments afterward. In most cases, students'
input noted areas that needed clarification and more examples, as well as those that were
unclear and confusing. During the revision process, student feedback was considered. By
clicking on the link, participants could view the questions and submit their responses.
Intervention phase:
The intervention condition: The research website was recommended to the students in the
intervention group of the study who had completed the pre-self-administered questionnaires.
There, they learned more about the study and what participating in it entailed. The members
of the intervention group were forced to create accounts on the website using personal
passwords after logging in. An informational session was conducted to teach the intervention
group's members how to utilize the learning management system (LMS) before they started their
virtual education. The participants were given instructions to complete the module on their
own for the duration of the session after receiving a brief orientation to the navigational
features in addition to the help screen in the module. The module can be used on mobile
devices, laptops, and personal computers. The online education module was only given to the
intervention group.
The intervention group's participants were permitted to access the module as many times as
necessary to finish all of the sessions (https://healthconcerns.tech/). The participants were
instructed to finish at least one and no more than two modules per week. Each module took 30
to 60 minutes to complete. The intervention was therefore planned to be finished in roughly 5
to 7 weeks. They were also told to heed the health advice that was given. Through website
chat, all of the participants' inquiries were addressed, and they received feedback.
The control condition is: Regarding the traditional health education group, the students had
full access to traditional face-to-face health education regarding PCOS for a similar
duration and by the same researchers. They were divided into seven groups. Each group had
nine to ten students. The nursing faculty's instructional hall served as the location for the
sessions. Each group's session lasted 5 hours over 2 days per week (10 a.m.-12 p.m.).
Lectures, discussions, brainstorming, blackboards, printed handouts, and audiovisual
materials were employed as teaching and learning tools throughout the sessions.
post-intervention phase Participants' knowledge, adaptive healthy measures, and attitude
about PCOS were evaluated using the same pre-test questionnaire for the intervention group
and the control group. Additionally, feedback about the website was assessed once after
completion of the module for the intervention group. All participants from the intervention
and control groups started and completed the PCOS educational module. The control group was
invited and given access to receive the identical web-based instructional module once data
collection, evaluation, and analysis were finished.
