The Validity and Reliability of the Turkish Version of the Testing Emotionalism After Recent Stroke - Questionnaire

NCT ID: NCT05822986

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-06

Study Completion Date

2024-05-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants who diagnosed with ischemic or hemorrhagic stroke

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Izgi Guven

Research Assistant (PT, MSc.), Faculty of Physiotherapy and Rehabilitation, Assistant Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pamukkale University

Denizli, Kinikli, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30887498 (View on PubMed)

Andersen 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.

Reference Type BACKGROUND
PMID: 24283580 (View on PubMed)

Aydemir, O. Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg. 1997; 8, 187-280.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 33345598 (View on PubMed)

Brott 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.

Reference Type BACKGROUND
PMID: 2749846 (View on PubMed)

Bryman, A., & Cramer, D. Quantitative Data Analysis with SPSS Release 10 for Windows: A Guide for Social Scientists (1st ed.). Routledge. 2001.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 9854975 (View on PubMed)

Carota, A., Calabrese, P. Poststroke Emotionalism. J Neurol Disord, 2013; 65, 928-929.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 16816786 (View on PubMed)

Gillespie 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.

Reference Type BACKGROUND
PMID: 26776437 (View on PubMed)

Goldstein 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.

Reference Type BACKGROUND
PMID: 11340215 (View on PubMed)

Gungen 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.

Reference Type BACKGROUND
PMID: 12794644 (View on PubMed)

House 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.

Reference Type BACKGROUND
PMID: 2499390 (View on PubMed)

Kim 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.

Reference Type BACKGROUND
PMID: 27733031 (View on PubMed)

Kucukdeveci 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.

Reference Type BACKGROUND
PMID: 10853723 (View on PubMed)

Marx RG, Menezes A, Horovitz L, Jones EC, Warren RF. A comparison of two time intervals for test-retest reliability of health status instruments. J Clin Epidemiol. 2003 Aug;56(8):730-5. doi: 10.1016/s0895-4356(03)00084-2.

Reference Type BACKGROUND
PMID: 12954464 (View on PubMed)

McAleese N, Guzman A, O'Rourke SJ, Gillespie DC. Post-stroke emotionalism: a qualitative investigation. Disabil Rehabil. 2021 Jan;43(2):192-200. doi: 10.1080/09638288.2019.1620876. Epub 2019 May 28.

Reference Type BACKGROUND
PMID: 31136206 (View on PubMed)

Miller 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.

Reference Type BACKGROUND
PMID: 21539437 (View on PubMed)

Moore SR, Gresham LS, Bromberg MB, Kasarkis EJ, Smith RA. A self report measure of affective lability. J Neurol Neurosurg Psychiatry. 1997 Jul;63(1):89-93. doi: 10.1136/jnnp.63.1.89.

Reference Type BACKGROUND
PMID: 9221973 (View on PubMed)

Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.

Reference Type BACKGROUND
PMID: 11491192 (View on PubMed)

Robinson 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.

Reference Type BACKGROUND
PMID: 8422080 (View on PubMed)

Schober P, Boer C, Schwarte LA. Correlation Coefficients: Appropriate Use and Interpretation. Anesth Analg. 2018 May;126(5):1763-1768. doi: 10.1213/ANE.0000000000002864.

Reference Type BACKGROUND
PMID: 29481436 (View on PubMed)

Sharma, 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.

Reference Type BACKGROUND

ten Have M, de Graaf R, van Dorsselaer S, Beekman A. Lifetime treatment contact and delay in treatment seeking after first onset of a mental disorder. Psychiatr Serv. 2013 Oct;64(10):981-9. doi: 10.1176/appi.ps.201200454.

Reference Type BACKGROUND
PMID: 23820725 (View on PubMed)

Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.

Reference Type BACKGROUND
PMID: 17161752 (View on PubMed)

Demir 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.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PAU/GUVEN-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Intervention for Earthquake Survivors
NCT06207695 RECRUITING NA