NCT06192381

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

November 28, 2023

Last Update Submit

December 20, 2023

Conditions

Keywords

Web-Based Learning ModelKnowledgeAttitude

Outcome Measures

Primary Outcomes (1)

  • The primary outcomes were improvement of students' knowledge, adaptive healthy measures and attitude regarding PCOS

    The primary outcomes were improvement of students' knowledge, adaptive healthy measures and attitude regarding PCOS. The primary outcomes was measured using the study questionnaire (Parts: 3-4 \& 5) pre and post-intervention.

    12 months

Secondary Outcomes (1)

  • The secondary outcome was students' satisfaction with the web-based educational sessions.

    12 months

Study Arms (2)

traditional health education group (control group)

NO INTERVENTION

Traditional health education group (control group) (n = 68) who received health education with the traditional face-to-face method

web-based health education group (intervention group)

EXPERIMENTAL

Web-based health education group (intervention group) (n = 68) who received health education with the Web-Based Learning Module (WBL).

Other: Web-Based Learning Module (WBL)

Interventions

To ensure a uniform starting point, the participants were recruited via faculty website and students' academic counseling services. At the baseline, after the initial assessment, the participants were randomized at a 1:1 allocation ratio into the following groups: 1) traditional health education group (control group) (n = 68) who received health education with traditional face-to-face method; 2) web-based health education group (intervention group) (n = 68) who received health education with Web-Based Learning Module (WBL).

web-based health education group (intervention group)

Eligibility Criteria

Age18 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Mansoura University,

Al Mansurah, Egypt

Location

Related Publications (1)

  • Mohamed RA, Taref NN, Osman NE, Keshta NHA, Alboghdady MA, Marzouk MM, Almowafy AA, Fadel EA. Effect of web-based health education on nursing students' knowledge, adaptive healthy measures and attitudes regarding polycystic ovary syndrome: a randomized controlled trial. BMC Nurs. 2024 Jul 15;23(1):479. doi: 10.1186/s12912-024-02015-7.

MeSH Terms

Conditions

Behavior

Study Officials

  • Safa H Alkalash, MD

    Umm Al-Qura Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of family medicine

Study Record Dates

First Submitted

November 28, 2023

First Posted

January 5, 2024

Study Start

December 11, 2022

Primary Completion

May 1, 2023

Study Completion

May 25, 2023

Last Updated

January 5, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations