NCT05829512

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

March 31, 2023

Last Update Submit

April 7, 2025

Conditions

Keywords

DysmenorrheaTurkish versionReliabilityValidityWaLIDD score

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    at first assessment

Study Arms (1)

Patients group

Individuals with dysmenorrhea

Other: Validity and reliability study

Interventions

Face-to-face questionnaire study

Patients group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals with dysmenorrhea between the ages of 18-45

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Merkez, Tokat Province, 60250, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns 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

March 31, 2023

First Posted

April 25, 2023

Study Start

April 1, 2023

Primary Completion

March 22, 2025

Study Completion

March 22, 2025

Last Updated

April 8, 2025

Record last verified: 2023-04

Locations