StrokeNCT05822986
The Validity and Reliability of the Turkish Version of the Testing Emotionalism After Recent Stroke - Questionnaire
An observational study of Stroke, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to conduct Turkish validity and reliability study of Testing Emotionalism After Recent Stroke - Questionnaire (TEARS-Q) in order to use it for Turkish people with stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2021to 5 May 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants who were hospitalized in Pamukkale University Neurology Service with a diagnosis of stroke and who volunteered to participate in the study and fulfilled the criteria
Who may be able to join
- Participants who diagnosed with ischemic or hemorrhagic stroke
Who cannot join
- Aphasia
- Subarachnoid or off-axis bleeding
- Diagnosis of Transient Ischemic Attack
- Severe comorbidity in addition to stroke
- Dementia
- Cognitive or behavioral problems
- Life expectancy of less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Validity and Reliability of the Turkish Version of the Testing Emotionalism After Recent Stroke - Questionnaire (TEARS-Q)
This study was designed to conduct Turkish validity and reliability study of Testing Emotionalism After Recent Stroke - Questionnaire (TEARS-Q) in order to use it for Turkish people with stroke.
Read the detailed description
Post-stroke emotionality is defined as excessive and unseemly crying or laughing in the absence of a motivating stimulus or in response to stimuli that would not typically trigger such emotions. Emotionality is a severe neurological condition marked by a loss of control over emotional responses. This occurs at a rate of about 17% in the acute period (1 month following stroke). Emotionality is classified as crying, laughing, or both crying and laughing. Stroke patients are more likely than others to cry alone.
Abnormal emotional responses in the acute phase following stroke are often recognized as part of the adaptation process, which delays emotionality diagnosis. It is critical in therapeutic practice to identify emotionality from other affective illnesses, as well as mood and personality disorders. Post-stroke sadness is sometimes misinterpreted with emotionality. Underdiagnosis and misdiagnosis, on the other hand, have clinically detrimental implications such as increased social limitation, worse quality of life, and delayed help-seeking behavior.
There are different scales evaluating emotionality in the literature. Pathological Laughter and Crying Scale and Center for Neurological Sciences-Lability Scale have limited use in stroke patients and have uncertain psychometric properties (no cut-off scores, uncontrolled crying and laughing attacks cannot be evaluated in different sub-dimensions). ), that's why the Testing Emotionalism After Recent Stroke - Questionnaire (TEARS-Q) was developed.
The aim of this study is to provide a Turkish translation and cross-cultural adaption of the TEARS-Q, as well as to assess the validity and reliability of the Turkish version in patients with acute stroke.
The procedures and objectives of the research will be described to the participants verbally and in writing before to all evaluations, and signed agreement will be collected from the participants..
Participants in the research will complete a personal (gender, age, weight, height, body mass index, education level) and medical history form (comorbidity, stroke side, type of stroke, stroke age) constructed using available literature. The Standardized Mini-Mental Test will be used to assess participants' overall cognitive level, the American National Institutes of Health (NIHS) Stroke Scale to assess stroke severity, and the Hospital Anxiety and Depression Scale to assess anxiety levels. To assess construct validity, the EQ-5D General Quality of Life Scale, the Barthel Activities of Daily Living Index, and the Neurological Sciences Center - Lability Scale will be applied.
- Conditions
- Stroke
- Keywords
- Emotions, Stroke, Surveys and Questionnaires
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with stroke | Patients who were hospitalized in the Neurology Service of Pamukkale University Hospital and who had an acute stroke and who met the inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing Emotionalism After Recent Stroke - Questionnaire (TEARS-Q)
The TEARS-Q scale was developed in line with generally established diagnostic criteria for tearful emotional expression following stroke. It evaluates the crying emotional changes that occur in the two weeks following a stroke. It has a total of eight items on a five-point Likert scale (Strongly Agree, Agree, Not Sure, Disagree, Strongly Disagree). The scale runs from 0 to 16. While the questionnaire scores of 0 and 2 indicate the lack of emotionality, scores of 2 and above indicate present emotionality. The TEARS-Q questionnaire's first two items were designed to enable for fast clinical evaluation of post-stroke emotionality while minimizing participant burden. These items serve as criteria for continuing or discontinuing the survey and are used to identify patients who are likely to be emotional.
Measured: At Baseline and 1 week after the baseline
Standardized Mini Mental Test
The test, which consists of sub-dimensions of orientation, recording memory, attention and calculation, recall, and language, is widely used to measure an individual's cognitive ability in general. The maximum possible score from the test is 30. In Turkish culture, a score of less than 23/24 indicates moderate dementia.
Measured: At Baseline
National Institutes of Health Stroke Scale (NIHSS)
It is a reliable clinical follow-up scale of eleven items that determines the severity of stroke in stroke patients. The scale yields the highest possible score of 36. The lower the score attained, the better the individual's clinical condition. The NIHS grading system assigns >17 points to severe stroke, 8-16 points to moderate stroke, and 8 points to mild stroke.
Measured: At Baseline
EuroQol- 5 Dimension (EQ-5D) General Quality of Life Scale
It was created in 1987 by the EuroQol group. It is divided into two sections. The first half allows you to assess the individual's present health profile in five sub-dimensions (movement, self-care, typical activities, pain-discomfort, and anxiety-depression), and the second part allows you to assess the visual analog scale.
243 possible different health outcomes on the scale is defined. An index score ranging from -0.59 to 1 is calculated from the 5 dimensions of the scale. In the score function, a value of 0 indicates death, a value of 1 indicates perfect health, while negative values indicate unconsciousness, being confined to a bed, etc. shows the situations. In addition, there is a VAS (EQ-VAS) in the scale, which includes answers between 0 and 100, that is, "worst imaginable health status" and "best imaginable health status".
Measured: At Baseline
Barthel Index for Activities of Daily Living (ADL)
It is a measure used to assess stroke patients' functional independence in activities of daily life (nutrition, washing, self-care, dressing, bladder and bowel care, toilet, wheelchair transfer, mobility, and stair climbing). The overall score runs from 0 to 100. A score of zero implies total reliance, whereas a score of 100 shows total independence.
Measured: At Baseline
Hospital Anxiety and Depression Scale (HADS)
The Turkish validity and reliability study of the scale was conducted in order to determine the anxiety and depression status of patients with physical illness and to evaluate the individual's emotional status change. It has two sub-dimensions, depression and anxiety, and 14 questions in total. Each item is graded on a four-point Likert scale ranging from 0 to 3. Cut-off scores in the Turkish version were determined as 10 points for the anxiety sub-dimension and 7 points for the depression sub-dimension.
Measured: At Baseline
Center for Neurologic Study-Liability Scale (CNS-LS)
It is a 7-item self-report questionnaire translated into Turkish that evaluates the intensity and variety of emotions in the previous week. Indecisive laughter and indecisive tears are evaluated using two sub-dimensions. A total score of 14.5 or above is linked to emotional instability.
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start6 Oct 2021
- Primary completion1 May 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izgi Guven, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822986
- Sponsor's protocol ID
- PAU/GUVEN-001
- Status last verified
- Nov 2024
- First submitted
- 1 Feb 2023
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allida S, Patel K, House A, Hackett ML. Pharmaceutical interventions for emotionalism after stroke. Cochrane Database Syst Rev. 2019 Mar 19;3(3):CD003690. doi: 10.1002/14651858.CD003690.pub4.
PubMed 30887498Andersen G, Vestergaard K, Ingeman-Nielsen M. Post-stroke pathological crying: frequency and correlation to depression. Eur J Neurol. 1995 Mar;2(1):45-50. doi: 10.1111/j.1468-1331.1995.tb00092.x.
PubMed 24283580Aydemir, O. Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg. 1997; 8, 187-280.
Broomfield NM, West R, House A, Munyombwe T, Barber M, Gracey F, Gillespie DC, Walters M. Psychometric evaluation of a newly developed measure of emotionalism after stroke (TEARS-Q). Clin Rehabil. 2021 Jun;35(6):894-903. doi: 10.1177/0269215520981727. Epub 2020 Dec 21.
PubMed 33345598Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989 Jul;20(7):864-70. doi: 10.1161/01.str.20.7.864.
PubMed 2749846Bryman, A., & Cramer, D. Quantitative Data Analysis with SPSS Release 10 for Windows: A Guide for Social Scientists (1st ed.). Routledge. 2001.
Calvert T, Knapp P, House A. Psychological associations with emotionalism after stroke. J Neurol Neurosurg Psychiatry. 1998 Dec;65(6):928-9. doi: 10.1136/jnnp.65.6.928.
PubMed 9854975Carota, A., Calabrese, P. Poststroke Emotionalism. J Neurol Disord, 2013; 65, 928-929.
Cummings JL, Arciniegas DB, Brooks BR, Herndon RM, Lauterbach EC, Pioro EP, Robinson RG, Scharre DW, Schiffer RB, Weintraub D. Defining and diagnosing involuntary emotional expression disorder. CNS Spectr. 2006 Jun;11(S6):1-7. doi: 10.1017/s1092852900026614.
PubMed 16816786Gillespie DC, Cadden AP, Lees R, West RM, Broomfield NM. Prevalence of Pseudobulbar Affect following Stroke: A Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2016 Mar;25(3):688-94. doi: 10.1016/j.jstrokecerebrovasdis.2015.11.038. Epub 2016 Jan 5.
PubMed 26776437Goldstein LB, Jones MR, Matchar DB, Edwards LJ, Hoff J, Chilukuri V, Armstrong SB, Horner RD. Improving the reliability of stroke subgroup classification using the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) criteria. Stroke. 2001 May;32(5):1091-8. doi: 10.1161/01.str.32.5.1091.
PubMed 11340215Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
PubMed 12794644House A, Dennis M, Molyneux A, Warlow C, Hawton K. Emotionalism after stroke. BMJ. 1989 Apr 15;298(6679):991-4. doi: 10.1136/bmj.298.6679.991.
PubMed 2499390Kim JS. Post-stroke Mood and Emotional Disturbances: Pharmacological Therapy Based on Mechanisms. J Stroke. 2016 Sep;18(3):244-255. doi: 10.5853/jos.2016.01144. Epub 2016 Sep 30.
PubMed 27733031Kucukdeveci AA, Yavuzer G, Tennant A, Suldur N, Sonel B, Arasil T. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000 Jun;32(2):87-92.
PubMed 10853723
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of the Turkish Version of the Testing Emotionalism After Recent Stroke - Questionnaire (TEARS-Q)
- ClinicalTrials.gov ID
- NCT05822986
- Acronym / sponsor ID
- PAU/GUVEN-001
- Conditions
- Stroke
- Keywords
- Emotions, Stroke, Surveys and Questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 21 Apr 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 was designed to conduct Turkish validity and reliability study of Testing Emotionalism After Recent Stroke - Questionnaire (TEARS-Q) in order to use it for Turkish people with stroke.
Detailed description
Post-stroke emotionality is defined as excessive and unseemly crying or laughing in the absence of a motivating stimulus or in response to stimuli that would not typically trigger such emotions. Emotionality is a severe neurological condition marked by a loss of control over emotional responses. This occurs at a rate of about 17% in the acute period (1 month following stroke). Emotionality is classified as crying, laughing, or both crying and laughing. Stroke patients are more likely than others to cry alone.
Abnormal emotional responses in the acute phase following stroke are often recognized as part of the adaptation process, which delays emotionality diagnosis. It is critical in therapeutic practice to identify emotionality from other affective illnesses, as well as mood and personality disorders. Post-stroke sadness is sometimes misinterpreted with emotionality. Underdiagnosis and misdiagnosis, on the other hand, have clinically detrimental implications such as increased social limitation, worse quality of life, and delayed help-seeking behavior.
There are different scales evaluating emotionality in the literature. Pathological Laughter and Crying Scale and Center for Neurological Sciences-Lability Scale have limited use in stroke patients and have uncertain psychometric properties (no cut-off scores, uncontrolled crying and laughing attacks cannot be evaluated in different sub-dimensions). ), that's why the Testing Emotionalism After Recent Stroke - Questionnaire (TEARS-Q) was developed.
The aim of this study is to provide a Turkish translation and cross-cultural adaption of the TEARS-Q, as well as to assess the validity and reliability of the Turkish version in patients with acute stroke.
The procedures and objectives of the research will be described to the participants verbally and in writing before to all evaluations, and signed agreement will be collected from the participants..
Participants in the research will complete a personal (gender, age, weight, height, body mass index, education level) and medical history form (comorbidity, stroke side, type of stroke, stroke age) constructed using available literature. The Standardized Mini-Mental Test will be used to assess participants' overall cognitive level, the American National Institutes of Health (NIHS) Stroke Scale to assess stroke severity, and the Hospital Anxiety and Depression Scale to assess anxiety levels. To assess construct validity, the EQ-5D General Quality of Life Scale, the Barthel Activities of Daily Living Index, and the Neurological Sciences Center - Lability Scale will be applied.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with stroke | – | –Patients who were hospitalized in the Neurology Service of Pamukkale University Hospital and who had an acute stroke and who met the inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants who were hospitalized in Pamukkale University Neurology Service with a diagnosis of stroke and who volunteered to participate in the study and fulfilled the criteria
Key inclusion criteria (1 listed)
- Participants who diagnosed with ischemic or hemorrhagic stroke
Key exclusion criteria (7 listed)
- Aphasia
- Subarachnoid or off-axis bleeding
- Diagnosis of Transient Ischemic Attack
- Severe comorbidity in addition to stroke
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Testing Emotionalism After Recent Stroke - Questionnaire (TEARS-Q)
Time frame: At Baseline and 1 week after the baseline
The TEARS-Q scale was developed in line with generally established diagnostic criteria for tearful emotional expression following stroke. It evaluates the crying emotional changes that occur in the two weeks following a stroke. It has a total of eight items on a five-point Likert scale (Strongly Agree, Agree, Not Sure, Disagree, Strongly Disagree). The scale runs from 0 to 16. While the questionnaire scores of 0 and 2 indicate the lack of emotionality, scores of 2 and above indicate present emotionality. The TEARS-Q questionnaire's first two items were designed to enable for fast clinical evaluation of post-stroke emotionality while minimizing participant burden. These items serve as criteria for continuing or discontinuing the survey and are used to identify patients who are likely to be emotional.
Standardized Mini Mental Test
Time frame: At Baseline
The test, which consists of sub-dimensions of orientation, recording memory, attention and calculation, recall, and language, is widely used to measure an individual's cognitive ability in general. The maximum possible score from the test is 30. In Turkish culture, a score of less than 23/24 indicates moderate dementia.
National Institutes of Health Stroke Scale (NIHSS)
Time frame: At Baseline
It is a reliable clinical follow-up scale of eleven items that determines the severity of stroke in stroke patients. The scale yields the highest possible score of 36. The lower the score attained, the better the individual's clinical condition. The NIHS grading system assigns >17 points to severe stroke, 8-16 points to moderate stroke, and 8 points to mild stroke.
EuroQol- 5 Dimension (EQ-5D) General Quality of Life Scale
Time frame: At Baseline
It was created in 1987 by the EuroQol group. It is divided into two sections. The first half allows you to assess the individual's present health profile in five sub-dimensions (movement, self-care, typical activities, pain-discomfort, and anxiety-depression), and the second part allows you to assess the visual analog scale. 243 possible different health outcomes on the scale is defined. An index score ranging from -0.59 to 1 is calculated from the 5 dimensions of the scale. In the score function, a value of 0 indicates death, a value of 1 indicates perfect health, while negative values indicate unconsciousness, being confined to a bed, etc. shows the situations. In addition, there is a VAS (EQ-VAS) in the scale, which includes answers between 0 and 100, that is, "worst imaginable health status" and "best imaginable health status".
Barthel Index for Activities of Daily Living (ADL)
Time frame: At Baseline
It is a measure used to assess stroke patients' functional independence in activities of daily life (nutrition, washing, self-care, dressing, bladder and bowel care, toilet, wheelchair transfer, mobility, and stair climbing). The overall score runs from 0 to 100. A score of zero implies total reliance, whereas a score of 100 shows total independence.
Hospital Anxiety and Depression Scale (HADS)
Time frame: At Baseline
The Turkish validity and reliability study of the scale was conducted in order to determine the anxiety and depression status of patients with physical illness and to evaluate the individual's emotional status change. It has two sub-dimensions, depression and anxiety, and 14 questions in total. Each item is graded on a four-point Likert scale ranging from 0 to 3. Cut-off scores in the Turkish version were determined as 10 points for the anxiety sub-dimension and 7 points for the depression sub-dimension.
Center for Neurologic Study-Liability Scale (CNS-LS)
Time frame: At Baseline
It is a 7-item self-report questionnaire translated into Turkish that evaluates the intensity and variety of emotions in the previous week. Indecisive laughter and indecisive tears are evaluated using two sub-dimensions. A total score of 14.5 or above is linked to emotional instability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 30887498Allida S, Patel K, House A, Hackett ML. Pharmaceutical interventions for emotionalism after stroke. Cochrane Database Syst Rev. 2019 Mar 19;3(3):CD003690. doi: 10.1002/14651858.CD003690.pub4.
- Background: PubMed 24283580Andersen G, Vestergaard K, Ingeman-Nielsen M. Post-stroke pathological crying: frequency and correlation to depression. Eur J Neurol. 1995 Mar;2(1):45-50. doi: 10.1111/j.1468-1331.1995.tb00092.x.
- BackgroundAydemir, O. Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg. 1997; 8, 187-280.
- Background: PubMed 33345598Broomfield NM, West R, House A, Munyombwe T, Barber M, Gracey F, Gillespie DC, Walters M. Psychometric evaluation of a newly developed measure of emotionalism after stroke (TEARS-Q). Clin Rehabil. 2021 Jun;35(6):894-903. doi: 10.1177/0269215520981727. Epub 2020 Dec 21.
- Background: PubMed 2749846Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989 Jul;20(7):864-70. doi: 10.1161/01.str.20.7.864.
- BackgroundBryman, A., & Cramer, D. Quantitative Data Analysis with SPSS Release 10 for Windows: A Guide for Social Scientists (1st ed.). Routledge. 2001.
- Background: PubMed 9854975Calvert T, Knapp P, House A. Psychological associations with emotionalism after stroke. J Neurol Neurosurg Psychiatry. 1998 Dec;65(6):928-9. doi: 10.1136/jnnp.65.6.928.
- BackgroundCarota, A., Calabrese, P. Poststroke Emotionalism. J Neurol Disord, 2013; 65, 928-929.
- Background: PubMed 16816786Cummings JL, Arciniegas DB, Brooks BR, Herndon RM, Lauterbach EC, Pioro EP, Robinson RG, Scharre DW, Schiffer RB, Weintraub D. Defining and diagnosing involuntary emotional expression disorder. CNS Spectr. 2006 Jun;11(S6):1-7. doi: 10.1017/s1092852900026614.
- Background: PubMed 26776437Gillespie DC, Cadden AP, Lees R, West RM, Broomfield NM. Prevalence of Pseudobulbar Affect following Stroke: A Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2016 Mar;25(3):688-94. doi: 10.1016/j.jstrokecerebrovasdis.2015.11.038. Epub 2016 Jan 5.
- Background: PubMed 11340215Goldstein LB, Jones MR, Matchar DB, Edwards LJ, Hoff J, Chilukuri V, Armstrong SB, Horner RD. Improving the reliability of stroke subgroup classification using the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) criteria. Stroke. 2001 May;32(5):1091-8. doi: 10.1161/01.str.32.5.1091.
- Background: PubMed 12794644Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Pamukkale 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 7 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: finished, as of the sponsor's last update on 8 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing Emotionalism After Recent Stroke - Questionnaire (TEARS-Q) (time frame: At Baseline and 1 week after the baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05822986, which also lists 26 linked publications.
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 8 Nov 2024.