Translation, Reliability, and Validity of Turkish Version of the Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) Score

April 7, 2025 updated by: Halime ARIKAN, Tokat Gaziosmanpasa University
Currently, there is no agreement in the use of standard questionnaires with adequate validation and structuring measures to classify the severity of dysmenorrhea. This may explain the variability in prevalence, conditions associated with absenteeism (work, school, etc.), or errors in the diagnostic approach to patients with pelvic pain. The aim of this study is to conduct a cross-cultural adaptation study of the Turkish version of the working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score, a tool designed to allow the identification of women with dysmenorrhea and those at high risk of obtaining medical clearance for the general population.

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

Dysmenorrhea is the most common gynecological condition worldwide, affecting 90% of women of reproductive age. It is usually characterized by various symptoms such as pain, nausea, fatigue, depression, diarrhea, headache, insomnia, anxiety, weakness. According to the pathophysiology of dysmenorrhea, it can be classified as primary dysmenorrhea in which there is no organic disease or secondary dysmenorrhea due to an underlying pelvic abnormality. Primary dysmenorrhea presents with spasmodic, crampy menstrual pain and discomfort in the absence of pelvic pathology, while secondary dysmenorrhea is associated with a specific pelvic pathology such as endometriosis, adenomyosis, or uterine fibroids. Working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score is an outcome scale designed as a scale type questionnaire (ability to work, location, intensity, days of pain, dysmenorrhea) integrating the features of score dysmenorrhea. This study will prove whether the Turkish version of the WaLIDD score is valid and reliable in evaluating women with dysmenorrhea. Statistical Package for Social Sciences (SPSS), version 22.0 computer package program for Windows will be used for statistical analysis. Statistical data will be expressed as mean±standard deviation (X±SD), median or percent (%). One-Sample Kolmogorov Smirnov test will be used to show the parametric or nonparametric distribution of the data. To determine the reliability of the WaLIDD score, test-retest and internal consistency analyzes will be performed at 7-day intervals. The test-retest value will be evaluated with the Intraclass Correlation Coefficient (ICC) and the internal consistency analysis will be evaluated with the Cronbach α value. The convergent validity of the WaLIDD score will be made using Pearson correlation analysis after calculating the total scores obtained from the Premenstrual Syndrome Impact Questionnaire, Pain Disability Index, and Big Five Inventory-10 questionnaires. Statistical significance value will be accepted as p<0.05.

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.
113

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Tokat
      • Merkez, 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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Individuals with dysmenorrhea between the ages of 18-45

Description

Inclusion Criteria:

  • Menstrual pain that begins within a few months or within 2 years of menarche
  • Pain that starts just before or at the beginning of menstruation,
  • Pain in the lower abdomen and back, which may radiate to the inner thighs or both
  • Pain, episodic and cramping pain, rarely lasting more than 72 hours,
  • Pain similar to one menstrual cycle and additional symptoms such as nausea and vomiting, fatigue, headache, dizziness and sleep disturbances,
  • Do not have any diagnosed chronic disease or a past or present psychological disorder,
  • Able to speak, read and write Turkish.

Exclusion Criteria:

  • Those with psychiatric and cognitive effects such as psychosis, bipolar disorder, eating disorder, moderate or severe depression or somatic symptom disorder,
  • Those who participate in psychotherapy because of dysmenorrhea symptoms (currently or in the past), women in pregnancy and lactation,
  • Having acute suicidal tendencies, gynecological diseases (hysterectomy, oophorectomy, gynecological cancer, polycystic ovary syndrome, endometriosis, infertility),
  • Those who have used antidepressants, benzodiazepines/antipsychotics, oral contraceptives or hormones (e.g. thyroid hormones) in the last 3 months or have had a change in their use,
  • With any neurological disorder,
  • Can't 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 dysmenorrhea
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
Working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score
Time Frame: at first assessment
Working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score consists of 4 items. It was designed as a scale-type questionnaire integrating features of dysmenorrhea: 1) Number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower extremities, inguinal region), 2) Wong-Baker pain rating (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more), 3) Number of painful days in the menstrual period (0, 1-2, 3-4, ≥5), and 4) Frequency of pain that prevents performing activities (never, almost never, almost always, always). Each item has a score between 0 and 3. The total score ranges from 0 to 12 points. An increased score indicates a greater degree of dysmenorrhea.
at first assessment
Premenstrual Syndrome Impact Questionnaire
Time Frame: at first assessment
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
Pain Disability Index
Time Frame: at first assessment
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
Big Five Inventory-10
Time Frame: at first assessment
Big Five Inventory-10 has been brought to the literature as an alternative and short version of Big Five Inventory-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 Inventory-10 was conducted.
at first assessment

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.
Tokat Gaziosmanpasa 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.
April 1, 2023

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.
March 22, 2025

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.
March 22, 2025

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).
March 31, 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.
April 13, 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.
April 25, 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.
April 8, 2025

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.
April 7, 2025

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.
April 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.
  • 83116987-215

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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