Psychological StressVisual artNCT07702682
Visual Art Therapy on Caregiver Burden
A study testing Visual arts design training program in people with Psychological Stress and Palliative Care, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effect of Zentangle practice on perceived caregiver burden, stress levels, and burnout among family caregivers of patients receiving palliative care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Palliative Care, Family Caregivers
- What is being tested?
- Visual arts design training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 20 Jan 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This study aims to determine the effect of Zentangle practice on perceived caregiver burden, stress levels, and burnout among family caregivers of patients receiving palliative care. Zentangle is a visual art therapy method used for meditative purposes by promoting creativity and focused attention in individuals under stress, which can facilitate mental relaxation, stress relief, and mindfulness. The study is designed as a randomized controlled experimental trial with a pretest-posttest design. The sample consists of 60 family caregivers of patients hospitalized in a palliative care unit, randomized into an intervention group (n=30) and a control group (n=30). Participants in the intervention group receive a two-week meditative art therapy intervention based on the Zentangle method, while data are collected through face-to-face interviews using validated psychological scales before and after the intervention period.
Read the 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.
- Conditions
- Psychological Stress, Palliative Care, Family Caregivers
- Being tested
- Visual arts design training program
- Keywords
- Zentangle, palliative care, visual art therapy, caregiver burden, burnout
- Medical subject headings
- Stress, Psychological, Caregiver Burden, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual arts design training programBehavioural
The fact that this type of sampling has never been applied before.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Visual arts design training program |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden Scale
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.
Measured: 2 months
Secondary outcomes (1)
Caregiver Stress Index
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Jan 2025
- Primary completion25 May 2025
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies 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
- This is a parallel-group, randomized controlled trial. Participants will be randomly assigned to either the experimental group or the control group with a allocation ratio.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin CETIN, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702682
- Sponsor's protocol ID
- 3171272024-184
- Acronym
- Visual art
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07702682
- Acronym / sponsor ID
- Visual art / 3171272024-184
- Conditions
- Psychological Stress, Palliative Care, Family Caregivers
- Keywords
- Zentangle, palliative care, visual art therapy, caregiver burden, burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 14 Jul 2026 (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.
This study aims to determine the effect of Zentangle practice on perceived caregiver burden, stress levels, and burnout among family caregivers of patients receiving palliative care. Zentangle is a visual art therapy method used for meditative purposes by promoting creativity and focused attention in individuals under stress, which can facilitate mental relaxation, stress relief, and mindfulness. The study is designed as a randomized controlled experimental trial with a pretest-posttest design. The sample consists of 60 family caregivers of patients hospitalized in a palliative care unit, randomized into an intervention group (n=30) and a control group (n=30). Participants in the intervention group receive a two-week meditative art therapy intervention based on the Zentangle method, while data are collected through face-to-face interviews using validated psychological scales before and after the intervention period.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel-group, randomized controlled trial. Participants will be randomly assigned to either the experimental group or the control group with a allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Visual arts design training programCaregivers 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. |
| Control group | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Visual arts design training programThe fact that this type of sampling has never been applied before. | Behavioural | Intervention group |
Primary outcome
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.
1 secondary outcome
Caregiver Stress Index
Time frame: 2 months
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 14 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual arts design training program in people with Psychological Stress and Palliative Care, run by Firat 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 5 inclusion and 3 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 14 Jul 2026. 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?
Caregiver Burden Scale (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.