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Completed

NCT Number: NCT06380959

Art-based Activities in Stroke Patients

Introduction and Aim: Life after stroke begins a difficult period in which functional capacity is very limited. Disability persists for a long time, and various problems such as hemiparesis, hemiplegia, dysarthria, dysphagia, urinary and bowel incontinence, which are frequently encountered after stroke, can affect the quality of life in the long term. As non-pharmacological approaches, especially non-invasive methods, have gained attention, creative arts-based therapies have often been recommended for stroke survivors because they have an arts-based approach without side effects. It is thought that the study conducted will contribute to the literature as there are not many studies in the literature. The aim of this study is to examine the effects of art-based activities on stroke patients' hope and self-efficacy levels. Its sub-purpose is to reveal the feelings and thoughts that arise with art objects obtained from art-based activities applied to stroke patients.

Materials and Methods: The study was conducted as a randomised controlled design. After the groups were determined, art-based activities module was applied to the intervention group for one week, while no additional intervention was made to the control group. Research data were collected using "Individual Introduction Form", "Herth Hope Index", "Generalized Self-Efficacy Scale. Data were analyzed with Statistical Package for the Social Sciences 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study.

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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

Interventional

Phase

Not applicable

Primary location

Ege University

Bornova, İzmir, 35100, Turkey (Türkiye)

About this study

Introduction and Aim: Life after stroke begins a difficult period in which functional capacity is very limited. Disability persists for a long time, and various problems such as hemiparesis, hemiplegia, dysarthria, dysphagia, urinary and bowel incontinence, which are frequently encountered after stroke, can affect the quality of life in the long term. As non-pharmacological approaches, especially non-invasive methods, have gained attention, creative arts-based therapies have often been recommended for stroke survivors because they have an arts-based approach without side effects. It is thought that the study conducted will contribute to the literature as there are not many studies in the literature. The aim of this study is to examine the effects of art-based activities on stroke patients' hope and self-efficacy levels. Its sub-purpose is to reveal the feelings and thoughts that arise with art objects obtained from art-based activities applied to stroke patients.

Materials and Methods: The study was conducted as a randomised controlled design. After the groups were determined, art-based activities module was applied to the intervention group for one week, while no additional intervention was made to the control group. This research was conducted at the Neurology Clinic of Health Sciences University Izmir Bozyaka Training and Research Hospital between October 2023 and February 2024. The participants consisted of 72 patient 36 in the invention group and 36 in the control group with Modified Rankin Scale scores of 2 and 3 who were hospitalized with a stroke diagnosis in the Neurology Clinic. Research data were collected using "Individual Introduction Form", "Herth Hope Index", "Generalized Self-Efficacy Scale. Data were analyzed with Statistical Package for the Social Sciences 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study.

This study was supported by Scientific and Technological Research Council of Turkey (TUBITAK) under the Grant Number 223K879.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being diagnosed with a stroke
  • Having a Modified Rankin Scale score of 2 and 3
  • Not having plegia in the dominant hemisphere
  • Not having a communication problem (cognitive, affective and verbal problems, etc.)
  • Not having any disease that affects decision-making processes (dementia and psychiatric disease, etc.)
  • Agreeing to participate in research

Exclusion criteria

  • Refusing to participate in research

Treatment and study plan

Art Based Activity

Other

Art Based Activity Module consists of 3 art-based activities under the titles "My Life Journey", "The Power Within Me" and "Letter to the Future". Each activity consists of three stages. In the first stage, the participants were made to practice breathing exercises. At this stage, the participant was expected to become aware of himself and his ideas. In the second stage, art activity was carried out. In the final stage, the revealed art object was concretized by the participants with a verbal expression. The materials used in the activities (dry paint, pastel paint, watercolor) are dermatologically tested and consist of anti-allergen products.

Primary outcomes

  1. Herth Hope Index

    Time frame: Day 1 and Day 7

    It is a scale developed to measure the level of hope. The index consists of a 12-item Likert-type scale. This 4-point likert-type scale index assesses adults' general level of hope. Each item is scored on a scale from 1 (strongly disagree) to 4 (strongly agree), with a total score ranging from 12 to 48. The higher the score, the higher the level of hope.

  2. Generalized Self-Efficacy Scale

    Time frame: Day 1 and Day 7

    It is a scale developed to measure the level of self-efficacy. The scores that can be obtained from the scale range from 10 to 40. An increase in the score indicates a higher level of self-efficacy in the individual.

  3. Individual Introduction Form

    Time frame: Baseline

    This form was prepared by the researcher and includes questions regarding the sociodemographic and disease characteristics of the patients.

Secondary outcomes

  1. Art Object Concretization Form

    Time frame: Day 2, Day 4 and Day 6

    It was created to concretize the unearthed art object through verbal expression. It contains a single open-ended question. After the art-based activity, the question was asked what the resulting art object meant.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effects of Art-based Activities on Hope and Self-efficacy in Stroke Patients

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 24, 2024
Registry last updated
Apr 29, 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.

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