TEMPS-A and Menopause Symptoms

NCT06972290 | Completed

• 1 other identifier: 777/28.09.23
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the relationship between temperament traits and menopausal symptoms using the TEMPS-A and MRS scales in women at menopausal transition stages. It is a cross-sectional observational study.

Conditions

Menopause; Personality; Temperament

Keywords

Menopausal Transition; Personality Traits; Personality Characteristics

Outcome Measures

Primary Outcomes (9)

• TEMPS-A Depressive Subscale Score at Baseline

  Score from the depressive subscale of the TEMPS-A questionnaire, assessing baseline depressive temperament

  Baseline (single time point at enrollment)

• TEMPS-A Cyclothymic Subscale Score at Baseline

  Score from the cyclothymic subscale of the TEMPS-A questionnaire, assessing mood instability.

  Baseline (single time point at enrollment)

• TEMPS-A Hyperthymic Subscale Score at Baseline

  Score from the hyperthymic subscale of the TEMPS-A questionnaire, assessing elevated or overly positive mood tendencies.

  Baseline (single time point at enrollment)

• TEMPS-A Irritable Subscale Score at Baseline

  Score from the irritable subscale of the TEMPS-A questionnaire, assessing baseline tendency toward irritability.

  Baseline (single time point at enrollment)

• TEMPS-A Anxious Subscale Score at Baseline

  Score from the anxious subscale of the TEMPS-A questionnaire, assessing trait anxiety.

  Baseline (single time point at enrollment)

• MRS Somatic Subscale Score at Baseline

  Somatic subscore of the MRS, measuring physical symptoms such as hot flashes and sleep problems.

  Baseline (single time point at enrollment)

• MRS Psychological Subscale Score at Baseline

  Psychological subscore of the MRS, reflecting symptoms such as depressive mood, irritability, and anxiety.

  Baseline (single time point at enrollment)

• MRS Urogenital Subscale Score at Baseline

  Urogenital subscore of the MRS, assessing symptoms such as vaginal dryness or urinary complaints.

  Baseline (single time point at enrollment)

• MRS Total Score at Baseline

  Total score from the Menopause Rating Scale (MRS), reflecting overall menopausal symptom severity.

  Baseline (single time point at enrollment)

Secondary Outcomes (1)

• Correlation Between TEMPS-A Subscale Scores and MRS Total/Subscale Scores

  Baseline (single time point at enrollment)

Eligibility Criteria

• Age: Up to 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women in the menopausal transition stage, classified as STRAW stages -1, +1a, and +1b, attending menopause outpatient clinics.

You may qualify if:

• Women classified as STRAW stages -1, +1a, and +1b (menopausal transition stages)
• Ability to complete questionnaires and provide informed consent

You may not qualify if:

• History of hormone therapy during the past 6 months
• History of surgical menopause (bilateral oophorectomy)
• Presence of severe physical disorders (e.g., malignancy, severe cardiovascular diseases)
• Presence of severe psychological disorders (e.g., major depressive disorder, psychosis)

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Bağcılar Training and Reserach Hospital

Istanbul, 34200, Turkey (Türkiye)

Location

Study Officials

• Cemile Ilhan, MD

  Bagcilar Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Obstetrics and Gynecology Specialist

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 15, 2025
• Study Start: January 1, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)