Cross-cultural Adaptation, Validity and Reliability of the Turkish Version of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ)

NCT05725447 | Completed

• 1 other identifier: 83116987-760
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Premenstrual Syndrome

Keywords

Premenstrual syndrome; Turkish version; Translation; Reliability; Validity

Outcome Measures

Primary Outcomes (6)

• Premenstrual Syndrome Impact Questionnaire

  Premenstrual Syndrome Impact Questionnaire consists of 18 items. It evaluates 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. It has a 4-point Likert-type answer system. The lowest score is 18 and the highest score is 72. The higher the score, the higher the impaction.

  first and second assessment (baseline and 1 week)

• Premenstrual Coping Measure

  The Premenstrual Coping Measure was developed to assess the ability of Australian women aged 18-49 to cope with premenstrual symptoms. Each item of the five-point Likert-type scale, which consists of 5 sub-dimensions, is scored between 1 and 5. No evaluation is made on the Premenstrual Coping Measure total score. As the score obtained from the sub-dimensions of the scale increases, the ability to cope with premenstrual symptoms also increases. The lowest score is 27, the highest score is 135. Increasing score indicates better coping ability. Turkish version, validity and reliability study of Premenstrual Coping Measure was conducted.

  at first assessment (baseline)

• Pain Disability Index

  The Pain Disability Index is a self-administered, short and easy scale that measures the extent to which the pain secondary to ongoing discomfort affects the daily life of the individual and the level of disability developed due to this reason. The scale consists of seven questions. The individual is asked to rate the effects of pain on seven functional activities of daily living, consisting of family-home responsibilities, leisure time, occupation, social activity, sexual life, and self-care, by giving a score of 0 to 10 for all questions (0= not prevent, 5=moderate prevents, 10= I'am completely inadequate). The total score ranges from 0 to 70. 40 and above means a high level of disability. High scores indicate that the disability is severe. Turkish version, validity and reliability study is available.

  at first assessment (baseline)

• Big Five Personality Traits Scale-10

  Big Five Personality Traits Scale-10 has been brought to the literature as an alternative and short version of Big Five Personality Traits Scale-44. The scale consists of 10 items and 5 sub-dimensions. The scale was evaluated with a 5-point Likert-type rating, as "Strongly Disagree", "Slightly Disagree", "Neither Agree nor Disagree", "Agree Slightly" and "Strongly Agree". The statements numbered 1-3-4-5-7 in the scale were reversed. The lowest score is 10, the highest score is 50. Increasing score and decreasing score according to sub-scales express better and worse personality traits. Turkish version, validity and reliability study of Big Five Personality Traits Scale-10 was conducted.

  at first assessment (baseline)

• Premenstrual Syndrome Scale

  The Premenstrual Syndrome Scale is a scale that aims to measure the severity of premenstrual symptoms. This scale, which is widely used in Turkey, includes 44 discourses marked by the individual considering "being in the period one week before menstruation". Premenstrual Syndrome Scale with five-point Likert-type consists of 9 sub-dimensions (depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, bloating). The lowest score that can be obtained from the scale is 44, and the highest score is 220. The sub-dimension scores are obtained by summing the items in these dimensions, and the Premenstrual Syndrome Scale total score is found by the sum of the sub-dimension scores. Those with a Premenstrual Syndrome Scale total score greater than 50% are classified as premenstrual syndrome positive. A higher Premenstrual Syndrome Scale score indicates more severe premenstrual symptoms.

  at first assessment (baseline)

• Premenstrual Symptoms Impact Survey

  The Premenstrual Symptoms Impact Survey is a 5-point Likert-type scale consisting of 6 items developed as a web-based one to evaluate the impact of premenstrual symptoms on health-related quality of life. As stated in the directive of the scale, to be answered according to the "last premenstrual period"; It has six items on quality of life, including mental health, social functionality, vitality, and role functionality. The evaluation of each substance is made between "1 (no effect)" and "5 (high effect)" according to the degree of impact of the relevant area. The total score of the scale ranges from 6-30, and high scores indicate worsening quality of life. A Turkish validity and reliability study was conducted and it was stated that the scale could evaluate the status and treatment results of PMS in women of reproductive age.

  at first assessment (baseline)

Study Arms (1)

Patients group

Individuals with premenstrual syndrome

Other: Validity and reliability study

Interventions

Validity and reliability study OTHER

Face-to-face questionnaire study

Patients group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Individuals with premenstrual syndrome between the ages of 18-45

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 13, 2023
• Study Start: November 7, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TU (1)