Premenstrual SyndromeNCT05725447
Cross-cultural Adaptation, Validity and Reliability of the Turkish Version of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ)
An observational study of Premenstrual Syndrome, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study is aimed to carry out the Turkish version validity and reliability of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Validity and reliability study
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Individuals with premenstrual syndrome between the ages of 18-45
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, 60250
About this study
This study is aimed to carry out the Turkish version validity and reliability of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ).
Read the 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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Validity and reliability study
- Keywords
- Premenstrual syndrome, Turkish version, Translation, Reliability, Validity
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validity and reliability studyOther
Face-to-face questionnaire study
| Study group | Role | What they receive |
|---|---|---|
| Patients group | Individuals with premenstrual syndrome Receives: Other: Validity and reliability study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at first assessment (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start7 Nov 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime ARIKAN, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725447
- Sponsor's protocol ID
- 83116987-760
- Status last verified
- Feb 2023
- First submitted
- 16 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation, Validity and Reliability of the Turkish Version of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ)
- ClinicalTrials.gov ID
- NCT05725447
- Acronym / sponsor ID
- 83116987-760
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual syndrome, Turkish version, Translation, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Other: Validity and reliability studyIndividuals with premenstrual syndrome |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals with premenstrual syndrome between the ages of 18-45
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validity and reliability studyFace-to-face questionnaire study | Other | Patients group |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Yes
Related trials for Premenstrual Syndrome
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THE EFFECT OF A REFLEXOLOGY PROGRAM ON PREMENSTRUAL SYNDROME SYMPTOMS, QUALİTY OF LİFE AND GENERAL COMFORT
Premenstrual Syndrome-PMS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premenstrual Syndrome, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual Syndrome Impact Questionnaire (time frame: first and second assessment (baseline and 1 week)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.