- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07702682
Visual Art Therapy on Caregiver Burden (Visual art)
The Effect of Visual Art Therapy Applied to Family Caregivers of Patients Hospitalized in a Palliative Care Unit on Caregiver Burden, Caregiving Stress, and Burnout: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Zentangle is a visual art therapy method that can be used for meditative purposes by promoting creativity and focused attention in individuals under stress, thereby indirectly facilitating mental relaxation, stress relief, and mindfulness.
Aim: This study aimed to determine the effect of Zentangle practice on perceived caregiver burden, stress levels, and burnout among family caregivers of patients receiving palliative care.
Design: This study was designed as a randomized controlled experimental trial with a pretest-posttest design and was conducted between March and June 2025.
Setting/Participants: The study sample consisted of 60 family caregivers of patients hospitalized in a palliative care unit, including 30 participants in the intervention group and 30 in the control group.
Intervention: Participants in the intervention group received a two-week meditative art therapy intervention based on the Zentangle method. The control group followed the standard routine care process without the art therapy intervention.
Data Collection: Data were collected through face-to-face interviews. The data collection tools included an Individual Descriptive Information Form, the Caregiver Burden Scale, the Caregiver Stress Index, and the Maslach Burnout Inventory-General Survey. These tools were administered to both groups as pretest measures before the intervention and as posttest measures immediately following the completion of the two-week study period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Elâzığ
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Elâzığ, Elâzığ, Turkey (Türkiye), 23100
- Fırat University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Being a family caregiver of a patient hospitalized in the palliative care unit
Volunteering to participate in the study
Being aged 18 years or older
Being able to communicate in the local language
Providing care for the patient for at least one month
Exclusion Criteria:
Having a previously diagnosed major psychiatric illness or cognitive impairment that prevents participation in art therapy
Having visual or physical impairments that interfere with performing fine motor tasks required for the Zentangle method
Participating in any other concurrent psychological or art therapy intervention during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Caregivers in this group will receive Zentangle training in addition to standard hospital routines.
The program aims to provide informative instruction on the method and support caregivers.
|
The fact that this type of sampling has never been applied before.
|
|
No Intervention: Control group
Caregivers in this group will follow the standard hospital routine and receive regular follow-ups without any additional intervention, education, or specific training program during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver Burden Scale
Time Frame: 2 months
|
Outcome Measure Title: Change from baseline in Caregiver Burden Scale scores at 2 weeks. Description: Caregiver burden is assessed using the Caregiver Burden Scale. The scale evaluates the physical, emotional, and social burden experienced by caregivers. Total scores range from 0 to 88, with higher scores indicating a higher perceived caregiver burden. |
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver Stress Index
Time Frame: 2 months
|
Outcome Measure Title: Change from baseline in Caregiver Stress Index scores at 2 weeks. Description: Caregiver stress levels are assessed using the Caregiver Stress Index. This tool evaluates the stress related to caregiving activities. Total scores range from 0 to 13, with higher scores indicating a higher level of caregiver stress. |
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3171272024-184
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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