PainNCT06052735
Association Among Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Caregivers of Stroke Individuals
A study testing Correlation research in people with Pain and Discomfort, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine pain perception, temporomandibular disorder severity and spine health in caregivers of stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Discomfort, Caregiver
- What is being tested?
- Correlation research
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be volunteer
Who cannot join
- Those who cannot speak, read or write Turkish.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tokat Gaziosmanpasa University
Tokat Province, 60250
Halime ARIKAN, PhD, +90 546 576 51 32, halimearikan92@gmail.com
About this study
This study aims to examine pain perception, temporomandibular disorder severity and spine health in caregivers of stroke patients.
Read the 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.
- Conditions
- Pain, Discomfort, Caregiver, Temporomandibular Disorder, Spine
- Being tested
- Correlation research
- Keywords
- Caregiver, Pain, Discomfort, Spine, Temporomandibular disorder
- Medical subject headings
- Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correlation researchOther
The relationship among pain perception, temporomandibular disorder severity and spine health
| Study group | Role | What they receive |
|---|---|---|
| Correlation arm | Other | Not described Receives: Other: Correlation research |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Aug 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Arikan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052735
- Sponsor's protocol ID
- 13.26
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Among Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Caregivers of Stroke Individuals
- ClinicalTrials.gov ID
- NCT06052735
- Acronym / sponsor ID
- 13.26
- Conditions
- Pain, Discomfort, Caregiver, Temporomandibular Disorder, Spine
- Keywords
- Caregiver, Pain, Discomfort, Spine, Temporomandibular disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Correlation arm | Other | Other: Correlation research |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be volunteer
Key exclusion criteria (1 listed)
- Those who cannot speak, read or write Turkish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Correlation researchThe relationship among pain perception, temporomandibular disorder severity and spine health | Other | Correlation arm |
Primary outcome
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 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
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). Its Turkish version, validity, and reliability study is available.
Spine Functional Index
Time frame: up to 3 months
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
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 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Correlation research in people with Pain and Discomfort, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halime ARIKAN, PhD (+90 546 576 51 32, halimearikan92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Centrality of Pain Scale (time frame: up to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023; AzTrials last refreshed its copy on 26 Oct 2026.