NCT04819087

Brief Summary

The pelvic floor serves as stability and support as it is the postural balance and core resource base for the pelvic organs. A dysfunction in the organs in this area can affect the pelvic floor muscles, the functioning of an organs in the muscles. Incontinence organ prolapse, pelvic pain and sexual problems may occur when the support or stability of the pelvic floor is impaired. Pelvic floor novelization is not always seen weakness. Sometimes excessive contractions and excessive activity in muscle tone can be seen. Stress and anxiety-related tension are the main causes of pelvic floor dysfunctions. Involuntary contractions and excessive muscle tone in the pelvic floor muscles cause chronic pelvic pain syndrome, constipation and dyssynergic defecation problems. Some of these patients have complaints of tightening teeth in the temporamandibular joint, grinding teeth at night, together with contractions in the pelvic floor. The aim of this study is to investigate the effect of pelvic floor improvement on tinnitus level as a result of dysfunctional condition in temporamandibular joint with treatment practices of pelvic floor patients with excessive muscle activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

March 11, 2021

Last Update Submit

July 18, 2025

Conditions

Keywords

TinnitusTemporomandibular Joint DisordersPelvic Floor Disorders

Outcome Measures

Primary Outcomes (3)

  • Tinnitus Disability Questionnaire

    The application of the questionnaire, which is not affected by hearing loss, age and gender, gives both easy and psychometric clearer measurements. The questionnaire consisting of 25 questions examines the perception of tinnitus and psychosocial status of the patient

    Change from Baseline and 10 Weeks

  • Fonseca Anamnestic Index

    FAI is a questionnaire consisting of 10 questions that determine the presence of pain in TME, head, back areas and during chewing, parafunctional habits, movement restriction, clique, malocclusion, emotional stress

    Change from Baseline and 10 Weeks

  • Oral Behavioral Survey Questions

    In the pathogenesis of TMD, parafunctional habits such as day and night tooth tightening, tooth grinding, nail eating, lip biting, cheek biting, pen biting, chewing gum play an important role. A positive association has often been reported between TMD and parafunctional habits. "Oral Behavior Checklist (OBC)", a survey study consisting of 21 Questions, is used to diagnose such oral habits

    Change from Baseline and 10 Weeks

Study Arms (1)

Patients

EXPERIMENTAL

Patients with Pelvic Floor Dysfunction Related Temporamandibular Joint Problems and Tinnitus

Behavioral: Questionnaires and Rehabilitation Programs

Interventions

Questionnaires and Rehabilitation Programs

Also known as: Tinnitus Disability Questionnaire, Fonseca Questionnaire, Oral Habits Questionnaire, pelvic floor muscle rehabilitation with biofeedback, diaphragm breathing training, Electrical stimulation
Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18-65 years
  • Patients with Pelvic Plate Disorders
  • Patients with Tinnitus Patients with Temporomandibular Joint Disorders

You may not qualify if:

  • Patients under 18 years and over 65 years
  • Patients without Pelvic Plate Disorders
  • Patients without Tinnitus
  • Patients without Temporomandibular Joint Disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay Üniversitesi

Konya, Karatay, 42020, Turkey (Türkiye)

Location

Related Publications (4)

  • Aksoy S, Firat Y, Alpar R. The Tinnitus Handicap Inventory: a study of validity and reliability. Int Tinnitus J. 2007;13(2):94-8.

    PMID: 18229787BACKGROUND
  • Ayalı, A., Ramoğlu, S. (2014). Kuzey kıbrıs'ta diş hekimliği fakültesi öğrencilerinde temporomandibuler eklem disfonksiyonu'nun prevalansı ve şiddetinin araştırılması, Atatürk Üniv. Diş Hek. Fak. Derg. Cilt:24, Sayı:3, Yıl: 2014, Sayfa: 367-372

    BACKGROUND
  • Langguth B, Goodey R, Azevedo A, Bjorne A, Cacace A, Crocetti A, Del Bo L, De Ridder D, Diges I, Elbert T, Flor H, Herraiz C, Ganz Sanchez T, Eichhammer P, Figueiredo R, Hajak G, Kleinjung T, Landgrebe M, Londero A, Lainez MJ, Mazzoli M, Meikle MB, Melcher J, Rauschecker JP, Sand PG, Struve M, Van de Heyning P, Van Dijk P, Vergara R. Consensus for tinnitus patient assessment and treatment outcome measurement: Tinnitus Research Initiative meeting, Regensburg, July 2006. Prog Brain Res. 2007;166:525-36. doi: 10.1016/S0079-6123(07)66050-6.

    PMID: 17956816BACKGROUND
  • Türken, R., Büyük, S. K., Yaşa, Y. (2020). Diş Hekimliği Fakültesi Öğrencilerinde Temporomandibular Eklem Rahatsızlıklarının ve Ağız Sağlığı Alışkanlıklarının Değerlendirilmesi, ACU Sağlık Bil Derg 2020; 11(2):208-213, https://doi.org/10.31067/0.2018.83

    BACKGROUND

MeSH Terms

Conditions

TinnitusTemporomandibular Joint DisordersPelvic Floor Disorders

Interventions

Surveys and QuestionnairesBiofeedback, PsychologyElectric Stimulation

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalPhysical Stimulation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: It is planned to include patients diagnosed with pelvic floor dysfunction between the ages of 18-65 in the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 26, 2021

Study Start

December 13, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations