StrokeNCT06380959
Art-based Activities in Stroke Patients
A study testing Art Based Activity in people with Stroke, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Art Based Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2023to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Refusing to participate in research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Art-based Activities on Hope and Self-efficacy 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Art Based Activity
- Keywords
- stroke, art therapy, Self-efficacy, Hope
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art Based ActivityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Art Based Activity Group | Experimental | The art-based activity module consists of 3 activities planned for 7 days. Receives: Other: Art Based Activity |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Herth Hope Index
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.
Measured: Day 1 and Day 7
Generalized Self-Efficacy Scale
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.
Measured: Day 1 and Day 7
Individual Introduction Form
This form was prepared by the researcher and includes questions regarding the sociodemographic and disease characteristics of the patients.
Measured: Baseline
Secondary outcomes (1)
Art Object Concretization Form
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.
Measured: Day 2, Day 4 and Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start2 Oct 2023
- Primary completion31 Dec 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Oksel, Ege University
- Investigators
- Esra OKSEL, PhD, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380959
- Sponsor's protocol ID
- 223K879
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1430629
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Art-based Activities on Hope and Self-efficacy in Stroke Patients
- ClinicalTrials.gov ID
- NCT06380959
- Acronym / sponsor ID
- 223K879
- Conditions
- Stroke
- Keywords
- stroke, art therapy, Self-efficacy, Hope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled
| Arm | Type | Receives |
|---|---|---|
| Art Based Activity Group | Experimental | Other: Art Based ActivityThe art-based activity module consists of 3 activities planned for 7 days. |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.)
Key exclusion criteria (1 listed)
- Refusing to participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art Based ActivityArt 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. | Other | Art Based Activity Group |
Primary outcome
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.
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.
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.
1 secondary outcome
Art Object Concretization Form
Time frame: Day 2, Day 4 and Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Background: PubMed 1430629Herth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra OKSEL, PhD study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Based Activity in people with Stroke, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Herth Hope Index (time frame: Day 1 and Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.