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

NCT07684430 | Completed DMC

• 2 other identifiers: PVF2026PCOS001EKK25-26/19/01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

Digital Health; Health Education; Self-Management; Quality of Life; Health Promotion

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life

  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.

Study Arms (2)

Digital Health Education Program

EXPERIMENTAL

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

Routine Care

ACTIVE COMPARATOR

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

Interventions

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.

Digital Health Education Program

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.

Routine Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women diagnosed with polycystic ovary syndrome (PCOS) who meet the study eligibility criteria are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Pouran Varvani Farahani

Nicosia, Haspolat, Cyprus

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Health Education

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Pouran Varvani Farahani, PhD

  PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To reduce bias, the outcome assessor and the statistician responsible for data analysis were blinded to group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University

Model Details: Participants were assigned to two parallel groups. Women in the intervention group received a four-week digital health education program delivered through WhatsApp, while women in the control group received routine care. Quality of life was assessed at baseline and one month after completion of the intervention using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ) to evaluate the effectiveness of the digital health education program.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: April 25, 2026
• Primary Completion: June 24, 2026
• Study Completion: June 30, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)