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

NCT ID: NCT06052722

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

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.

Conditions

Primary Dysmenorrhea; Premenstrual Syndrome; Temporomandibular Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Individuals with premenstrual syndrome

Level of relationship between premenstrual syndrome and temporomandibular disorders

Group Type: OTHER

Correlation assessment

Intervention Type: OTHER

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.

Individuals with primary dysmenorrhea

Level of relationship between primary dysmenorrhea and temporomandibular disorders

Group Type: OTHER

Correlation assessment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokat Gaziosmanpasa University

OTHER

Sponsor Role: lead

Responsible Party

Halime Arikan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tokat Gaziosmanpasa University

Tokat Province, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Halime ARIKAN, PhD

Role: CONTACT

halimearikan92@gmail.com

+90 546 576 51 32

Facility Contacts

Halime ARIKAN, PhD

Role: primary

halimearikan92@gmail.com

+90 546 576 51 32

Other Identifiers

13.21

Identifier Type: -

Identifier Source: org_study_id