Clinical trial NCT06380959: Art-based Activities in Stroke Patients
Official title: The Effects of Art-based Activities on Hope and Self-efficacy in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
art therapy
Self-efficacy
Hope
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Herth Hope Index
timeFrame: Day 1 and Day 7
measure: Generalized Self-Efficacy Scale
timeFrame: Day 1 and Day 7
measure: Individual Introduction Form
timeFrame: Baseline
Secondary outcomes:
measure: Art Object Concretization Form
timeFrame: Day 2, Day 4 and Day 6
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University
state: İzmir
Study officials:
affiliation: Ege University
name: Esra OKSEL, PhD
role: STUDY_DIRECTOR
References:
citation: Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.