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Completed

NCT Number: NCT07402980

Development of the Polycystic Ovary Syndrome Symptoms Inventory

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Psychological Distress Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Bolu Abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

About this study

The research is a methodological scale development study.

A review of the literature reveals that despite strong evidence linking Polycystic Ovary Syndrome (PCOS) to anxiety, depression, and diminished quality of life, current assessment tools often fail to adequately represent psychological symptoms. There is a critical need for holistic and culturally sensitive instruments that address both the physical and psychological dimensions of PCOS. It is therefore thought that the developed scale will fill an important gap.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Polycystic Ovary Syndrome Symptom Severity and Distress Inventory

    Time frame: At the time of survey completion (Baseline)

    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.

Secondary outcomes

  1. Participant Information Form

    Time frame: At the time of survey completion (Baseline)

    A 10-item form developed by the researchers to collect sociodemographic data, such as age and educational background, as well as specific questions regarding the participants' Polycystic Ovary Syndrome (PCOS) history.

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

    Time frame: At the time of survey completion (Baseline)

    This scale is designed to determine the impact of Polycystic Ovary Syndrome (PCOS) on quality of life. It consists of 50 items and 6 subscales: psychosocial and emotional, fertility, sexual function, obesity and menstrual disorders, hirsutism, and coping. Total scores range from 50 to 250. Subscale scores are determined by calculating the average score of the items answered within that specific domain. Unanswered items are excluded from the average score calculation.

  3. Kessler Psychological Distress Scale (K10-PDS)

    Time frame: At the time of survey completion (Baseline)

    This 10-item scale measures the frequency of symptoms such as nervousness, hopelessness, sadness, worthlessness, and fatigue to assess non-specific psychological distress. The scale is a 5-point Likert-type instrument, with total scores ranging from 10 to 50. Higher scores indicate higher levels of psychological distress.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

Polycystic Ovary Syndrome Symptoms Inventory: Development, Validity and Reliability in Turkey

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 23, 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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