Clinical trial NCT06052722: The Relationship of Premenstrual Syndrome and Primary Dysmenorrhea With Severity of Temporomandibular Disorders
Official title: The Relationship of Premenstrual Syndrome and Primary Dysmenorrhea With Severity of Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Dysmenorrhea
Premenstrual Syndrome
Temporomandibular Disorder
Keywords: Primary Dysmenorrhea
Premenstrual Syndrome
Temporomandibular Disorder
Correlation
Relationship
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Premenstrual Syndrome Impact Scale
timeFrame: up to 3 months
measure: Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea Score
timeFrame: up to 3 months
measure: Fonseca Anamnestic Index
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
Study officials:
References: