Development of the Polycystic Ovary Syndrome Symptoms Inventory

NCT07402980 | Completed

• 1 other identifier: AIBU-HEM-BB-01
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

Polycystic Ovary Syndrome Symptom Severity and Distress Inventory: Development, Validity and Reliability in Turkey The goal of this observational study is to develop and validate a self-report inventory that assesses Polycystic Ovary Syndrome (PCOS) symptoms and the level of distress experienced by women diagnosed with PCOS. The main question it aims to answer is: Is the newly developed inventory a valid and reliable instrument for assessing PCOS symptoms and related distress in women? Participants will answer online survey questions including a demographic information form and three scales evaluating psychological health and PCOS related symptoms, including the newly developed symptom and distress inventory.

Conditions

Polycystic Ovary Syndrome; Psychological Distress

Keywords

Polycystic Ovary Syndrome; Symptom Burden; Psychological Distress; Inventory Development

Outcome Measures

Primary Outcomes (1)

• Polycystic Ovary Syndrome Symptom Severity and Distress Inventory

  The newly developed inventory consists of 34 items in total, with 17 items dedicated to evaluating PCOS symptom severity and 17 items for measuring distress levels. Each item is scored on a scale from 0 to 10. Total scores are calculated separately for symptom severity and distress levels, with each score ranging from 0 to 100. Higher scores on these measurements indicate an increase in both symptom severity and the level of distress experienced by the participant.

  At the time of survey completion (Baseline)

Secondary Outcomes (3)

• Participant Information Form

  At the time of survey completion (Baseline)

• Health-Related Quality of Life Questionnaire-50 for Polycystic Ovary Syndrome (PCOSQ-50)

  At the time of survey completion (Baseline)

• Kessler Psychological Distress Scale (K10-PDS)

  At the time of survey completion (Baseline)

Study Arms (1)

Women diagnosed with PCOS

Women aged 18-49 who report having been diagnosed with PCOS will be included in the study.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of women aged 18-49 who have been diagnosed with Polycystic Ovary Syndrome (PCOS). The study aims to reach a sample size of at least 85 to 170 participants. Women who meet the inclusion criteria and agree to participate on a voluntary basis will be invited to the study. Data will be collected via an online survey form prepared by the researchers. Participants will be recruited through social media platforms (such as WhatsApp and Instagram). To ensure ethical standards, an informed consent text will be included at the beginning of the online form, and a mandatory question will be used to confirm voluntary participation. Additionally, a mandatory screening question regarding PCOS diagnosis will be included to verify that participants meet the inclusion criteria; individuals without a PCOS diagnosis will be excluded from the sample.

You may qualify if:

• Being a woman aged 18-49 (of reproductive age) who states she has been diagnosed with PCOS
• Being able to read and understand Turkish
• Volunteering to participate in the study

You may not qualify if:

• Having a disease that could cause symptoms similar to PCOS (such as Cushing's syndrome, thyroid dysfunction, hyperprolactinemia, androgen-secreting tumors)

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

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

Study Officials

• Melisa Bulut, PhD

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 11, 2026
• Study Start: October 1, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)