The Relationship of Premenstrual Syndrome and Primary Dysmenorrhea With Severity of Temporomandibular Disorders

September 21, 2023 updated by: Halime ARIKAN, Tokat Gaziosmanpasa University
Premenstrual pain, menstrual pain, other pains, and somatic symptoms may occur together. Therefore, this study aims to examine the severity of temporomandibular disorders in individuals complaining of premenstrual syndrome or dysmenorrhea and its relationship.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

The sample of the study will consist of at least 60 adult female individuals over the age of 18 with premenstrual syndrome or primary dysmenorrhea residing in Tokat. Premenstrual Dysphoria Disorder DSM-5 Diagnostic Criteria will be used to determine the presence of premenstrual syndrome. In cases of classic primary dysmenorrhea, a pelvic examination is not necessary to begin treatment. There is no specific test to identify primary dysmenorrhea, but individuals with the classic presentation are candidates for empiric therapy. These individuals were identified according to the following characteristics: 1) Menstrual pain that begins within a few months or within 2 years after menarche, 2) Pain that begins just before or at the beginning of menstruation, 3) Pain that can radiate to the lower abdomen and back, inner thighs, or both, 4) ) Pain that rarely lasts more than 72 hours, 5) Episodic and cramp-like pain, 6) Similar pain from one menstrual cycle to the next, and 7) Additional symptoms such as nausea and vomiting, fatigue, headache, dizziness and sleep disturbances. To exclude secondary dysmenorrhea: 1) Dysmenorrhea occurring during the first one or two cycles after menarche, 2) Dysmenorrhea starting after the age of 25, 3) Late onset of dysmenorrhea after a history of no pain with menstruation, 4) Infertility (endometriosis, pelvic inflammatory disease). ), heavy menstrual flow, or irregular cycles (adenomyosis, fibroids, polyps), individuals with dyspareunia will be recorded as secondary dysmenorrhea and excluded from the study. In line with these criteria, an inquiry will be made and appropriate individuals will be included in the study. In this study, power analysis was performed with the G*Power program to determine the sample size. Taking the type one error as (α)=0.05, the power of the study as (β)=0.95, the acceptable correlation rate as (r)=0.70, and the negligible correlation rate as (r)=0.30, the sample required to determine the relationship between premenstrual syndrome and temporomandibular disorders severity was determined. The size was calculated as 30 participants. Likewise, 30 participants will be required to determine the relationship between dysmenorrhea and temporomandibular disorders severity. Therefore, the number of individuals required to participate in this study was calculated as 60. After individuals' sociodemographic information is questioned, data will be collected with other outcome measurements. Individuals will be invited verbally to the study and a face-to-face survey will be administered to those who volunteer.

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.
Interventional

Enrollment (Estimated)

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.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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, Turkey, 60250
        • Tokat Gaziosmanpasa University
        • Contact:

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

Description

Inclusion Criteria:

  • To be volunteer

Exclusion Criteria:

  • Having any gynecological or obstetric diagnosis other than premenstrual syndrome or primary dysmenorrhea
  • Being pregnant
  • Having any neurological, psychiatric or cognitive disorder.

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

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Other: Individuals with premenstrual syndrome
Level of relationship between premenstrual syndrome and temporomandibular disorders
Other: Correlation assessment
The relationship between the Premenstrual Syndrome Impact Scale and the Fonseca Anamnestic Index will be examined for individuals with premenstrual syndrome. The relationship between Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea Score and Fonseca Anamnestic Index will be examined for individuals with primary dysmenorrhea.
Other: Individuals with primary dysmenorrhea
Level of relationship between primary dysmenorrhea and temporomandibular disorders
Other: Correlation assessment
The relationship between the Premenstrual Syndrome Impact Scale and the Fonseca Anamnestic Index will be examined for individuals with premenstrual syndrome. The relationship between Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea Score and Fonseca Anamnestic Index will be examined for individuals with primary dysmenorrhea.

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 Scale
Time Frame: up to 3 months
The Premenstrual Syndrome Impact Scale consists of 18 items. It assesses psychological stress and functional interaction in daily life and is designed for premenstrual symptoms. It considers the complex and multifaceted nature of the disorder, thus facilitating the diagnosis process by assessing the necessary impact and enabling the planning and evaluation of treatment. It has a 4-point Likert-type answering system. Increasing the score means that the exposure increases. The questionnaire is valid and reliable in the Turkish population.
up to 3 months
Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea Score
Time Frame: up to 3 months
Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea Score consists of 4 items. It was designed as a scale-type questionnaire integrating dysmenorrhea features: 1) Number of anatomical pain locations (no part of the body, lower abdomen, lumbar area, lower extremities, groin area), 2) Wong-Baker pain rating (doesn't hurt, hurts a little, hurts a little more, hurts a lot, hurts more, hurts a lot, hurts a lot), 3) Number of painful days during 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 varies between 0 and 12 points. An increasing score indicates a greater degree of dysmenorrhea. The scale is valid and reliable in Turkish population.
up to 3 months
Fonseca Anamnestic Index
Time Frame: up to 3 months
The presence and severity of temporomandibular disorders in individuals will be questioned with the Fonseca Anamnestic Index. The Fonseca Anamnestic Index consists of 10 questions. The participant is asked to answer each question as 'Yes' (10 points), 'No' (0 points), and 'Sometimes' (5 points). The questionnaire score is scored for all questions, and temporomandibular disorder severity is classified according to the total score: no temporomandibular disorder (0-15 points), mild temporomandibular disorder (20-40 points), moderate temporomandibular disorder (45-65 points), severe temporomandibular disorder (70-100). Turkish version validity and reliability study was conducted.
up to 3 months

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 (Estimated)

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.
October 1, 2023

Primary Completion (Estimated)

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 1, 2023

Study Completion (Estimated)

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 31, 2023

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).
September 13, 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.
September 21, 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.
September 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.
September 25, 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.
September 21, 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.
September 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.
  • 13.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings