Polycystic Ovary Syndrome (PCOS)
Conditions
Keywords
Digital Health, Health Education, Self-Management, Quality of Life, Health Promotion
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.
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.
Interventions
BEHAVIORALDigital 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.
BEHAVIORALroutine 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.
Sponsors
Near East University, Turkey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
To reduce bias, the outcome assessor and the statistician responsible for data analysis were blinded to group assignments.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | 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. |
Countries
Cyprus
Contacts
PRINCIPAL_INVESTIGATORPouran Varvani Farahani, PhD
PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University
Outcome results
None listed