NCT07702682

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

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

January 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 1, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

Zentanglepalliative carevisual art therapycaregiver burdenburnout

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Secondary Outcomes (1)

  • Caregiver Stress Index

    2 months

Study Arms (2)

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.

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.

Interventions

The fact that this type of sampling has never been applied before.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat University

Elâzığ, Elâzığ, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stress, PsychologicalCaregiver BurdenBurnout, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

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

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 14, 2026

Study Start

January 15, 2025

Primary Completion

May 25, 2025

Study Completion

January 20, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Locations