Clinical trial NCT06972290: TEMPS-A and Menopause Symptoms
Official title: The Relationship Between Temperament and Menopause Symptoms: A Cross-Sectional Study Using TEMPS-A and MRS Scales
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Menopause
Personality
Temperament
Keywords: Menopausal Transition
Personality Traits
Personality Characteristics
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-15
Enrollment: 100
Sex: FEMALE
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: TEMPS-A Depressive Subscale Score at Baseline
timeFrame: Baseline (single time point at enrollment)
measure: TEMPS-A Cyclothymic Subscale Score at Baseline
timeFrame: Baseline (single time point at enrollment)
measure: TEMPS-A Hyperthymic Subscale Score at Baseline
timeFrame: Baseline (single time point at enrollment)
measure: TEMPS-A Irritable Subscale Score at Baseline
timeFrame: Baseline (single time point at enrollment)
measure: TEMPS-A Anxious Subscale Score at Baseline
timeFrame: Baseline (single time point at enrollment)
measure: MRS Somatic Subscale Score at Baseline
timeFrame: Baseline (single time point at enrollment)
measure: MRS Psychological Subscale Score at Baseline
timeFrame: Baseline (single time point at enrollment)
measure: MRS Urogenital Subscale Score at Baseline
timeFrame: Baseline (single time point at enrollment)
measure: MRS Total Score at Baseline
timeFrame: Baseline (single time point at enrollment)
Secondary outcomes:
measure: Correlation Between TEMPS-A Subscale Scores and MRS Total/Subscale Scores
timeFrame: Baseline (single time point at enrollment)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bağcılar Training and Reserach Hospital
Study officials:
affiliation: Bagcilar Training and Research Hospital
name: Cemile Ilhan, MD
role: PRINCIPAL_INVESTIGATOR
References: