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

November 6, 2024 updated by: Izgi Guven, Pamukkale University

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kinikli
      • Denizli, Kinikli, Turkey, 20160
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At Baseline and 1 week after the baseline
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.
At Baseline
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.
At Baseline
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.
At Baseline
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.
At Baseline
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.
At Baseline
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".
At Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2021

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 5, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

April 9, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAU/GUVEN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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