Skip to main content
OpenTrials
Completed

NCT Number: NCT05822986

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University

Denizli, Kinikli, 20160, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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".

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

The Validity and Reliability of the Turkish Version of the Testing Emotionalism After Recent Stroke - Questionnaire (TEARS-Q)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2023
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.