Clinical trial NCT05725447: Cross-cultural Adaptation, Validity and Reliability of the Turkish Version of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ)
Official title: Cross-cultural Adaptation, Validity and Reliability of the Turkish Version of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premenstrual Syndrome
Keywords: Premenstrual syndrome
Turkish version
Translation
Reliability
Validity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with premenstrual syndrome between the ages of 18-45

Brief summary: This study is aimed to carry out the Turkish version validity and reliability of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ).

Detailed description: Although the severity of premenstrual syndrome (PMS) symptoms varies among women, it is known that PMS symptoms are common, especially in young adult women. The most common symptoms are nervousness, breast tenderness, depression, abdominal swelling and general body edema. Along with personal and mental differences, it has been one of the important problems to cope with PMS symptoms, which are frequently experienced in a variable order from mild to severe in each menstrual cycle period. Sometimes the complaints are so severe that they negatively affect the individual's activities of daily living. This syndrome, which negatively affects the quality of life of the individual, also prepares the ground for the formation of serious mental problems. Most questionnaires for the assessment of premenstrual symptoms only measure the presence and/ or intensity of premenstrual symptoms by a retrospective or prospective grading, not the effect caused by the symptoms. Premenstrual Syndrome Impact Questionnaire (PMS-IQ) assesses functional interaction in daily life as well as psychological stress and is designed for premenstrual symptoms. It takes into account the complex and multifaceted nature of the disorder, thus facilitating the diagnosis process by evaluating the necessary effect and enabling the planning and evaluation of the treatment. There is no Turkish version and validity study of PMS-IQ. This study is aimed to evaluate the validity and reliability of the Turkish version of PMS-IQ. The study of validity and reliability is planned with 99 individuals with PMS. The sociodemographic characteristics of the individuals will be questioned by the investigators and then the patients will be evaluated with PMS-IQ, Premenstrual Coping Measure (PCM), Pain Disability Index (PDI), Big Five Personality Traits Scale (BFPTS), Premenstrual Syndrome Scale (PSS), and Premenstrual Symptoms Impact Survey (PMSIS). The test-retest will be re-administered by face-to-face interview technique after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-45
* Meeting the diagnostic criteria for premenstrual dysphoria according to DSM-5
* Not having any diagnosed chronic disease
* Not having past or present mental illness
* Those who can speak, read and write Turkish
* Volunteered to participate in the study

Exclusion Criteria:

* Psychiatric and cognitive impairment such as psychosis, bipolar disorder, eating disorder, moderate or severe depression, or somatic symptom disorder
* Having participated in psychotherapy for premenstrual symptoms (currently or in the past)
* Being pregnant and breastfeeding
* Having acute suicidal tendencies
* Having gynecological diseases (hysterectomy, oophorectomy, gynecological cancer, polycystic ovary syndrome, endometriosis, infertility)
* Using or changing in the past 3 months antidepressants, benzodiazepines/antipsychotics, oral contraceptives or hormones (e.g. thyroid hormones)
* Having any neurological disorder
* Not being able to speak, read or write Turkish

Primary outcomes:
measure: Premenstrual Syndrome Impact Questionnaire
timeFrame: first and second assessment (baseline and 1 week)
measure: Premenstrual Coping Measure
timeFrame: at first assessment (baseline)
measure: Pain Disability Index
timeFrame: at first assessment (baseline)
measure: Big Five Personality Traits Scale-10
timeFrame: at first assessment (baseline)
measure: Premenstrual Syndrome Scale
timeFrame: at first assessment (baseline)
measure: Premenstrual Symptoms Impact Survey
timeFrame: at first assessment (baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
Study officials:
References: