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Completed

NCT Number: NCT07684430

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Digital Health Education Program

Behavioral

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.

Routine Care

Behavioral

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Near East University, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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