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Association Among Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Caregivers of Stroke Individuals

Primary Purpose

Pain, Discomfort, Caregiver

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Correlation research
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain focused on measuring Caregiver, Pain, Discomfort, Spine, Temporomandibular disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: To be volunteer Exclusion Criteria: Those who cannot speak, read or write Turkish.

Sites / Locations

  • Tokat Gaziosmanpasa UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Correlation arm

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
September 21, 2023
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT06052735
Brief Title
Association Among Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Caregivers of Stroke Individuals
Official Title
Association Among Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Caregivers of Stroke Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to examine pain perception, temporomandibular disorder severity and spine health in caregivers of stroke patients.
Detailed Description
The sample of the study will consist of caregivers who reside in Tokat and Kırıkkale, are over 18 years old, care for an individual who has had a stroke and volunteer to participate in the study. Individuals will be contacted via social media, and squestionnaires will be administered face-to-face to those who agree to participate in the study. According to the G*Power analysis, if the sample size is α= 0.05, β= 0.80, acceptable correlation coefficient r= 0.70, and negligible correlation coefficient r= 0.20, 16 individuals are sufficient to measure the relationship between two parameters. Since the relationship between four parameters will be evaluated, a total of 64 individuals are required. Data for the study will be collected face-to-face by individual researchers using data tools that individuals can fill in themselves. Data will be collected from individuals with The Centrality of Pain Scale, Discomfort Intolerance Scale, Spine Functional Index, and Fonseca Anamnestic Index instruments. Statistical Package for Social Sciences (SPSS), version 22.0 computer package program for Windows, will be used for statistical analysis. Statistical data will be expressed as mean ± standard deviation (X±SD), median or percentage (%). One Sample Kolmogorov Smirnov test will be performed to show parametric or nonparametric distribution of the data. When parametric test assumptions are met, the relationship between parameters is determined by Spearman correlation test; When parametric test assumptions are not met, the relationship between the parameters will be examined with the Pearson correlation test. Statistical significance value will be accepted as p<0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Discomfort, Caregiver, Temporomandibular Disorder, Spine
Keywords
Caregiver, Pain, Discomfort, Spine, Temporomandibular disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Correlation arm
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Correlation research
Intervention Description
The relationship among pain perception, temporomandibular disorder severity and spine health
Primary Outcome Measure Information:
Title
The Centrality of Pain Scale
Description
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.
Time Frame
up to 3 months
Title
Discomfort Intolerance Scale
Description
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.
Time Frame
up to 3 months
Title
Spine Functional Index
Description
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.
Time Frame
up to 3 months
Title
Fonseca Anamnestic Index
Description
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.
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be volunteer Exclusion Criteria: Those who cannot speak, read or write Turkish.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com
Facility Information:
Facility Name
Tokat Gaziosmanpasa University
City
Tokat
ZIP/Postal Code
60250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Association Among Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Caregivers of Stroke Individuals

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