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

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06052722
• Other study ID #: 13.21
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Tokat Gaziosmanpasa University
• Contact: Halime ARIKAN, PhD
• Phone: +90 546 576 51 32
• Email: halimearikan92[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Premenstrual Syndrome
• Primary Dysmenorrhea
• Syndrome
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.

Locations

Country	Name	City	State
Turkey	Tokat Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premenstrual Syndrome Impact Scale	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
Primary	Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea Score	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
Primary	Fonseca Anamnestic Index	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