Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06052722
Other study ID # 13.21
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05006963 - Tele-Rehabilitation in Patients With Temporomandibular Dysfunction N/A
Completed NCT04102306 - Assessing Motor Imagery Ability of Tongue and Mouth in Subjects With and With no Temporomandibular Disorders
Not yet recruiting NCT05297604 - Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders Phase 2
Recruiting NCT06035341 - The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction N/A
Recruiting NCT03849534 - Treatment of Temporomandibular Disorders in Children and Adolsecents N/A
Not yet recruiting NCT05021874 - The Effect of Different Physiotherapeutic Stimuli on Stomatognathic System Structures. N/A
Recruiting NCT05232604 - How is Aerobic Exercise Compared to Localized Pain Relief Exercises in Patients With Jaw Pain and Neck Pain? N/A
Completed NCT04557878 - Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction Phase 2
Completed NCT03726060 - Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders N/A
Not yet recruiting NCT06123351 - Forward Head Posture Correction Impact on Temporomandibular Dysfunction N/A
Completed NCT03619889 - The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder N/A
Completed NCT01000389 - A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism N/A
Completed NCT00743223 - The Frequency Forward Head Posture in Subjects With Temporomandibular Disorder N/A
Completed NCT03300297 - Cervical Spine Thrust Joint Manipulation for Temporomandibular Disorder N/A
Completed NCT06065826 - Forward Head Posture and Myogenic TMD Association in Smartphone Overuse
Completed NCT04087005 - Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial N/A
Recruiting NCT03696706 - Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction Phase 2
Completed NCT04041271 - Jaw Kinematics and Muscle Activation in Patients With Non-specific Chronic Neck Pain
Recruiting NCT03096301 - Photobiomodulation in Temporomandibular Disorder N/A
Recruiting NCT05305833 - Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease Phase 1/Phase 2