The Validity and Reliability of the Turkish Version of the Testing Emotionalism After Recent Stroke - Questionnaire
1 other identifier
observational
85
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 6, 2021
CompletedFirst Submitted
Initial submission to the registry
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2024
CompletedNovember 8, 2024
November 1, 2024
2.6 years
February 1, 2023
November 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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.
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.
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.
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".
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.
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.
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.
At Baseline
Study Arms (1)
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
Eligibility Criteria
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
You may qualify if:
- Participants who diagnosed with ischemic or hemorrhagic stroke
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pamukkale University
Denizli, Kinikli, 20160, Turkey (TĂ¼rkiye)
Related Publications (26)
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BACKGROUNDBroomfield 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.
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PMID: 9854975BACKGROUNDCarota, A., Calabrese, P. Poststroke Emotionalism. J Neurol Disord, 2013; 65, 928-929.
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PMID: 16816786BACKGROUNDGillespie 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.
PMID: 26776437BACKGROUNDGoldstein 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.
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PMID: 12794644BACKGROUNDHouse 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.
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PMID: 31136206BACKGROUNDMiller A, Pratt H, Schiffer RB. Pseudobulbar affect: the spectrum of clinical presentations, etiologies and treatments. Expert Rev Neurother. 2011 Jul;11(7):1077-88. doi: 10.1586/ern.11.68. Epub 2011 May 3.
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PMID: 11491192BACKGROUNDRobinson RG, Parikh RM, Lipsey JR, Starkstein SE, Price TR. Pathological laughing and crying following stroke: validation of a measurement scale and a double-blind treatment study. Am J Psychiatry. 1993 Feb;150(2):286-93. doi: 10.1176/ajp.150.2.286.
PMID: 8422080BACKGROUNDSchober P, Boer C, Schwarte LA. Correlation Coefficients: Appropriate Use and Interpretation. Anesth Analg. 2018 May;126(5):1763-1768. doi: 10.1213/ANE.0000000000002864.
PMID: 29481436BACKGROUNDSharma, B. A focus on reliability in developmental research through Cronbach's Alpha among medical, dental and paramedical professionals. Asian Pacific Journal of Health Science, APJHS. 2016; 3. 271-278. 10.21276/apjhs.2016.3.4.
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PMID: 17161752BACKGROUNDDemir S. , Koskderelioglu A. , Karaoglan M. , Gedizlioglu M. , Togrol R. E. Pseudobulbar affect prevalence in Turkish multiple sclerosis patients. Med Sci Discov. 2018; 5(7): 279-283.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant (PT, MSc.), Faculty of Physiotherapy and Rehabilitation, Assistant Researcher
Study Record Dates
First Submitted
February 1, 2023
First Posted
April 21, 2023
Study Start
October 6, 2021
Primary Completion
May 1, 2024
Study Completion
May 5, 2024
Last Updated
November 8, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share