NCT06380959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 6, 2024

Last Update Submit

April 26, 2024

Conditions

Keywords

strokeart therapySelf-efficacyHope

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline

Secondary Outcomes (1)

  • Art Object Concretization Form

    Day 2, Day 4 and Day 6

Study Arms (2)

Art Based Activity Group

EXPERIMENTAL

The art-based activity module consists of 3 activities planned for 7 days.

Other: Art Based Activity

Control Group

NO INTERVENTION

No intervention

Interventions

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.

Art Based Activity Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Refusing to participate in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 1430629BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Esra OKSEL, PhD

    Ege University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised Controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2024

First Posted

April 24, 2024

Study Start

October 2, 2023

Primary Completion

December 31, 2023

Study Completion

February 29, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations