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NCT Number: NCT06972290

TEMPS-A and Menopause Symptoms

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.

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Key information

Conditions

Menopause Personality Temperament

Age range

Up to 55 year

Sex eligibility

Female

Study type

Observational

Primary location

Bağcılar Training and Reserach Hospital

Istanbul, 34200, Turkey (Türkiye)

About this study

This observational, cross-sectional study aims to investigate the relationship between temperament traits and menopausal symptoms in women in the menopausal transition stage, specifically classified as STRAW stages -1, +1a, and +1b. Participants are recruited from menopause outpatient clinics.

Data are collected through the administration of the validated Temperament Evaluation of Memphis, Pisa, Paris and San Diego Autoquestionnaire (TEMPS-A) and the Menopause Rating Scale (MRS).

Participants voluntarily complete the questionnaires after providing informed consent. All responses are anonymized and securely stored.

Quality assurance measures include verification of data entry, use of validated scales, and compliance with ethical standards approved by the Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee.

No interventions are applied; the study strictly follows observational registry procedures.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. TEMPS-A Depressive Subscale Score at Baseline

    Time frame: Baseline (single time point at enrollment)

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

  2. TEMPS-A Cyclothymic Subscale Score at Baseline

    Time frame: Baseline (single time point at enrollment)

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

  3. TEMPS-A Hyperthymic Subscale Score at Baseline

    Time frame: Baseline (single time point at enrollment)

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

  4. TEMPS-A Irritable Subscale Score at Baseline

    Time frame: Baseline (single time point at enrollment)

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

  5. TEMPS-A Anxious Subscale Score at Baseline

    Time frame: Baseline (single time point at enrollment)

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

  6. MRS Somatic Subscale Score at Baseline

    Time frame: Baseline (single time point at enrollment)

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

  7. MRS Psychological Subscale Score at Baseline

    Time frame: Baseline (single time point at enrollment)

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

  8. MRS Urogenital Subscale Score at Baseline

    Time frame: Baseline (single time point at enrollment)

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

  9. MRS Total Score at Baseline

    Time frame: Baseline (single time point at enrollment)

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

Secondary outcomes

  1. Correlation Between TEMPS-A Subscale Scores and MRS Total/Subscale Scores

    Time frame: Baseline (single time point at enrollment)

    The relationship between affective temperament traits (TEMPS-A: depressive, cyclothymic, hyperthymic, irritable, and anxious) and menopausal symptom severity (MRS total and subscale scores) will be assessed using Pearson or Spearman correlation coefficients. The analysis aims to determine whether specific temperament profiles are associated with increased symptom burden.

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

The Relationship Between Temperament and Menopause Symptoms: A Cross-Sectional Study Using TEMPS-A and MRS Scales

Acronym: TEMPS-MRS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 15, 2025
Registry last updated
Nov 18, 2025

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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