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

NCT06052722 | Unknown

• 1 other identifier: 13.21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea; Premenstrual Syndrome; Temporomandibular Disorder

Keywords

Primary Dysmenorrhea; Premenstrual Syndrome; Temporomandibular Disorder; Correlation; Relationship

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Individuals with premenstrual syndrome

OTHER

Level of relationship between premenstrual syndrome and temporomandibular disorders

Other: Correlation assessment

Individuals with primary dysmenorrhea

OTHER

Level of relationship between primary dysmenorrhea and temporomandibular disorders

Other: Correlation assessment

Interventions

Correlation assessment 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 premenstrual syndrome; Individuals with primary dysmenorrhea

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To be volunteer

You may not qualify if:

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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

Halime ARIKAN, PhD

CONTACT

+90 546 576 51 32; halimearikan92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 25, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Locations

TU (1)