Effect of a Digital Health Education Program on Quality of Life in Women With Polycystic Ovary Syndrome

June 29, 2026 updated by: Pouran Varvani Farahani, Near East University, Turkey

Effect of a Digital Health Education Program on Quality of Life in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial

This single-blind randomized controlled trial evaluated the effectiveness of a digital health education program delivered through WhatsApp in improving the quality of life of women with polycystic ovary syndrome (PCOS). Seventy women diagnosed with PCOS were enrolled from selected gynecology clinics in Imo State, Nigeria, and allocated to either an intervention group or a routine care control group. The intervention consisted of a four-week digital education program including 30 evidence-based educational messages. Quality of life was measured using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ) at baseline and one month after completion of the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Purpose

This study evaluated the effectiveness of a digital health education program delivered through WhatsApp in improving the quality of life of women diagnosed with polycystic ovary syndrome (PCOS).

Study Design

This was a single-blind randomized controlled trial conducted in selected women's health wards and gynecology clinics in Imo State, Nigeria. Two clinics with comparable characteristics were selected. One clinic was assigned to the intervention group and the other to the routine care control group.

Participants

A total of 70 women with PCOS who met the eligibility criteria participated in the study. Thirty-five participants were included in each study group.

Intervention

Participants in the intervention group received a four-week digital health education program through WhatsApp consisting of 30 structured educational messages covering PCOS, lifestyle modification, nutrition, physical activity, stress management, fertility, and prevention of long-term complications. Participants could communicate with the researchers throughout the intervention to ask questions and receive clarification.

Participants in the control group received routine care provided by the participating clinics. After completion of data collection, the educational materials were made available to the control group.

Outcome Assessment

Quality of life was assessed using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ), a validated disease-specific instrument. Assessments were completed at baseline and one month after completion of the intervention.

Ethical Considerations

The study received approval from the Cyprus International University Ethics Review Board (Approval No. EKK25-26/19/01). The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. Written informed consent was obtained from all participants before enrollment.

Statistical Analysis

Data will be analyzed using SPSS software. Descriptive statistics, independent t-tests, paired t-tests, chi-square tests, and other appropriate statistical tests will be performed. A two-sided P value of less than 0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
    • Haspolat
      • Nicosia, Haspolat, Cyprus
        • Pouran Varvani Farahani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women diagnosed with polycystic ovary syndrome
  2. Women aged 18-45 years
  3. Women attending the selected women's health wards and gynecology clinics during the study period
  4. Willingness to participate and provide written informed consent

Exclusion Criteria:

  1. Withdrawal of consent at any stage of the study
  2. Failure to complete either the pre-test or post-test assessments
  3. Incomplete participation in the educational intervention program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Health Education Program
Participants in this group received a four-week digital health education program delivered through WhatsApp. The intervention provided structured educational messages designed to improve knowledge, self-management, and quality of life among women with polycystic ovary syndrome (PCOS).
Behavioral: Digital Health Education Program
Participants received a four-week digital health education program delivered through WhatsApp. The intervention consisted of 30 structured educational messages covering polycystic ovary syndrome (PCOS), lifestyle modification, nutrition, physical activity, stress management, fertility, and prevention of long-term complications. Participants were encouraged to ask questions through WhatsApp, and researchers provided clarification when needed.
Active Comparator: Routine Care
Participants in this group received routine care and standard health information provided by the participating women's health wards and gynecology clinics. No digital health education program was provided during the study period.
Behavioral: routine care
Participants received routine care and standard health information provided by the participating women's health wards and gynecology clinics. They did not receive the digital health education program during the study period. After completion of data collection, the educational materials were provided to participants in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: Baseline (before the intervention) and 1 month after completion of the intervention.
The primary outcome measure evaluates changes in the quality of life of women diagnosed with polycystic ovary syndrome (PCOS) following the digital health education program. Quality of life is assessed using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ), a validated 26-item disease-specific instrument that measures emotional disturbances, body hair concerns, weight concerns, infertility problems, and menstrual problems. Higher scores indicate better quality of life.
Baseline (before the intervention) and 1 month after completion of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Near East University, Turkey

Investigators

  • Principal Investigator: Pouran Varvani Farahani, PhD, PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2026

Primary Completion (Actual)

June 24, 2026

Study Completion (Actual)

June 30, 2026

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVF2026PCOS001
  • EKK25-26/19/01 (Other Identifier: Cyprus International University Ethics Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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