- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06053008
The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals
Study Overview
Status
Detailed Description
The research sample will consist of elderly individuals who reside in Tokat and Kırıkkale, are over 65 years old, have good cognitive status, and volunteer 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, 64 individuals are required.
Data for the study will be collected face to face by researchers using The Centrality of Pain Scale, Discomfort Intolerance Scale, Spine Functional Index, and Fonseca Anamnestic Index, which can be filled in by individuals themselves.
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 the 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Halime ARIKAN, PhD
- Phone Number: +90 546 576 51 32
- Email: halimearikan92@gmail.com
Study Locations
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-
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Tokat, Turkey, 60250
- Recruiting
- Tokat Gaziosmanpaşa University
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Contact:
- Halime ARIKAN, PhD
- Phone Number: +90 546 576 51 32
- Email: halimearikan92@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To be volunteer
Exclusion Criteria:
- Having any neurological, psychiatric or cognitive disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Geriatric individuals
The relationship among pain perception, temporomandibular joint disorder severity and spine health
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The relationship between pain perception, temporomandibular joint disorder severity and spine health
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Centrality of Pain Scale
Time Frame: up to 3 months
|
The Centrality of Pain Scale will be used to assess pain perception.
It is a 10-item survey 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
Time Frame: up to 3 months
|
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).
A Turkish version, validity and reliability study is available.
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up to 3 months
|
Spine Functional Index
Time Frame: up to 3 months
|
The 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, 1.
The total score is calculated as a percentage, and a score approaching 100% indicates normal spinal functions.
Turkish version, validity, and reliability were tested.
|
up to 3 months
|
Fonseca Anamnestic Index
Time Frame: up to 3 months
|
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 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 (45-65 points).
70-100).
The Turkish version, validity, and reliability were tested.
|
up to 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13.27
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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