NCT06052735

Brief Summary

This study aims to examine pain perception, temporomandibular disorder severity and spine health in caregivers of stroke patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

September 13, 2023

Last Update Submit

September 21, 2023

Conditions

Keywords

CaregiverPainDiscomfortSpineTemporomandibular disorder

Outcome Measures

Primary Outcomes (4)

  • The Centrality of Pain Scale

    The Centrality of Pain Scale will be used to assess pain perception. It is a 10-item questionnaire in which each item is rated on a 5-point Likert type (1: strongly disagree, 2: disagree, 3: neither agree nor disagree, 4: agree, 5: strongly agree). Items 2, 4, and 9 are reverse scored. The total score is the sum of all item scores. Higher scores reflect more "centralized" pain. The maximum score is 50, and the minimum score is 10. Turkish version, validity, and reliability study was conducted.

    up to 3 months

  • Discomfort Intolerance Scale

    Tolerance to physical discomfort and pain will be evaluated with the Discomfort Intolerance Scale. The scale consists of 7-point Likert-type questions, and the answer options vary between 0 (not at all suitable for me) and 6 (completely suitable for me). Its Turkish version, validity, and reliability study is available.

    up to 3 months

  • Spine Functional Index

    Spine Functional Index is a scale of 25 questions developed to examine the impact of spine-related symptoms on functionality. Each question is scored as 0, 0.5, and 1. The total score is calculated as a percentage, and a score approaching 100% indicates normal spinal functions. The Turkish version, validity, and reliability were tested.

    up to 3 months

  • Fonseca Anamnestic Index

    The presence and severity of temporomandibular disorder in individuals will be evaluated 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 the severity of temporomandibular disorder is classified based on the total score: no temporomandibular disorder (0-15 points), mild temporomandibular disorder (20-40 points), moderate temporomandibular disorder (45-65 points), severe TMJD ( 70-100). The Turkish version, validity, and reliability were tested.

    up to 3 months

Study Arms (1)

Correlation arm

OTHER
Other: Correlation research

Interventions

The relationship among pain perception, temporomandibular disorder severity and spine health

Correlation arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be volunteer

You may not qualify if:

  • Those who cannot speak, read or write Turkish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
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

August 1, 2023

Primary Completion

October 1, 2023

Study Completion

October 31, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations