Polycystic Ovary Syndrome (PCOS)NCT07684430
Effect of a Digital Health Education Program on Quality of Life in Women With Polycystic Ovary Syndrome
A study testing Digital Health Education Program and routine care in people with Polycystic Ovary Syndrome (PCOS), run by Near East University, Turkey at 1 site in Cyprus.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Digital Health Education Program and routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCyprus
- Study dates
- 25 Apr 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- Digital Health Education Program, routine care
- Keywords
- Digital Health, Health Education, Self-Management, Quality of Life, Health Promotion
- Medical subject headings
- Polycystic Ovary Syndrome, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health Education ProgramBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before the intervention) and 1 month after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start25 Apr 2026
- Primary completion24 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pouran Varvani Farahani, Cyprus International University
- Investigators
- Pouran Varvani Farahani, PhD, Principal investigator, PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684430
- Sponsor's protocol ID
- PVF2026PCOS001
- Other IDs
- EKK25-26/19/01
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Digital Health Education Program on Quality of Life in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07684430
- Acronym / sponsor ID
- PVF2026PCOS001
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- Digital Health, Health Education, Self-Management, Quality of Life, Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital Health Education Program | Experimental | Behavioral: Digital Health Education ProgramParticipants 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). |
| Routine Care | Active comparator | Behavioral: routine careParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health Education ProgramParticipants 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. | Behavioural | Digital Health Education Program |
| routine careParticipants 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. | Behavioural | Routine Care |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers
Related trials for Polycystic Ovary Syndrome (PCOS)
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for PCOS
Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pouran Varvani Farahani, PhD principal investigator
PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Education Program and routine care in people with Polycystic Ovary Syndrome (PCOS), run by Near East University, Turkey at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (time frame: Baseline (before the intervention) and 1 month after completion of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.