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

February 2, 2023 updated by: Halime ARIKAN, Gazi University
This study is aimed to carry out the Turkish version validity and reliability of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tokat, Turkey, 60250
        • Tokat Gaziosmanpasa University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Individuals with premenstrual syndrome between the ages of 18-45

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients group
Individuals with premenstrual syndrome
Other: Validity and reliability study
Face-to-face questionnaire study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Premenstrual Syndrome Impact Questionnaire
Time Frame: first and second assessment (baseline and 1 week)
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
Time Frame: at first assessment (baseline)
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
Time Frame: at first assessment (baseline)
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
Time Frame: at first assessment (baseline)
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
Time Frame: at first assessment (baseline)
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
Time Frame: at first assessment (baseline)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 83116987-760

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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