DysmenorrheaNCT05829512
Translation, Reliability, and Validity of Turkish Version of the Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) Score
An observational study of Dysmenorrhea and Dysmenorrhea Primary, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dysmenorrhea, Dysmenorrhea Primary
- What is being tested?
- Validity and reliability study
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 22 Mar 2025
- 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 dysmenorrhea between the ages of 18-45
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Merkez, Tokat Province, 60250
About this study
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.
Read the 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.
- Conditions
- Dysmenorrhea, Dysmenorrhea Primary
- Being tested
- Validity and reliability study
- Keywords
- Dysmenorrhea, Turkish version, Reliability, Validity, WaLIDD score
- Medical subject headings
- Dysmenorrhea
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 dysmenorrhea Receives: Other: Validity and reliability study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score
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.
Measured: at first assessment
Premenstrual Syndrome Impact Questionnaire
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
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
Big Five Inventory-10
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.
Measured: at first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Apr 2023
- Primary completion22 Mar 2025
- Study completion22 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Arikan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829512
- Sponsor's protocol ID
- 83116987-215
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arikan H, Erol E. Working ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD): cross-cultural adaptation, reliability, and validity of the Turkish version. BMC Womens Health. 2025 Mar 22;25(1):133. doi: 10.1186/s12905-025-03673-8.
PubMed 40121462
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Reliability, and Validity of Turkish Version of the Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) Score
- ClinicalTrials.gov ID
- NCT05829512
- Acronym / sponsor ID
- 83116987-215
- Conditions
- Dysmenorrhea, Dysmenorrhea Primary
- Keywords
- Dysmenorrhea, Turkish version, Reliability, Validity, WaLIDD score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 22 Mar 2025 (actual)
- Study completion
- 22 Mar 2025 (actual)
- First posted
- 25 Apr 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Other: Validity and reliability studyIndividuals with dysmenorrhea |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals with dysmenorrhea between the ages of 18-45
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
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
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.
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.
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.
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.
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 8 Apr 2025.
- Derived from this study: PubMed 40121462Arikan H, Erol E. Working ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD): cross-cultural adaptation, reliability, and validity of the Turkish version. BMC Womens Health. 2025 Mar 22;25(1):133. doi: 10.1186/s12905-025-03673-8.
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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 Dysmenorrhea and Dysmenorrhea Primary, run by Tokat Gaziosmanpasa 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 7 inclusion and 6 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 8 Apr 2025. 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?
Working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score (time frame: at first assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05829512, which also lists 1 linked publication.
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 8 Apr 2025.