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临床试验/NCT06052722
NCT06052722尚未招募不适用

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

Tokat Gaziosmanpasa University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
2
主要终点
Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • To be volunteer

排除标准

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

结局指标

主要结局

Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea Score

时间窗: 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.

Premenstrual Syndrome Impact Scale

时间窗: 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.

Fonseca Anamnestic Index

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Tokat Gaziosmanpasa University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Halime Arikan

Assistant Professor

Tokat Gaziosmanpasa University

研究点 (2)

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