NCT05847231

Brief Summary

The word palliative comes from the Latin word "pallium" meaning "cover". The aim of palliative care is not to eliminate the cause of the disease; to alleviate the negative effects of the disease. Mandala painting, which is one of the non-pharmacological applications, is an art therapy technique that can provide psychological support and healing. Mandala painting is a safe and accessible activity that requires no special skills and can be used as a complementary strategy to support mental health. In the literature, it is stated that coloring mandala improves psychological symptoms and relieves the person. The artistic view of nursing is to understand the needs of the individual, the sources of anxiety, anxiety and stress, and then to develop practices that will increase his/her self-confidence and resilience by increasing his/her ability and competence level. Therefore, this study was planned to examine the effect of mandala painting applied to caregivers caring for palliative care patients on perceived stress, anxiety level and quality of life. This research, which is planned as a randomized experimental study with pretest-posttest control group, will be a study for informal caregivers who have patients in the palliative service of fethi sekin city hospital between May 2023 and December 2023. The sample will consist of 80 (40 experimental, 40 control) caregivers who accepted the research that met the research criteria. Experimental group will be composed of caregivers who will paint mandalas. In addition to verbal and written information, the Patient Description Form, Perceived Stress Scale (PSÖ), State-Trait Anxiety Scale (WHO) and Short Form (SF-36) Quality of Life Scale have been applied to the 1st Stage. measurement will be obtained. The program will be implemented for 4 weeks, 4 days a week. 16 pre-selected mandala drawings will be printed separately on A4 papers and a new drawing will be given to caregivers every week. Mandala coloring papers and 12 colored felt-tip crayons will be given to each participant by the researcher. After the end of the sessions, the second measurements will be obtained by applying the Perceived Stress Scale (PSS), State-Trait Anxiety Scale (DSQ) and Short Form-36 (SF-36) Quality of Life Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 25, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

April 25, 2023

Last Update Submit

March 27, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Perceived Stress Scale (PSS)Perceived Stress Scale (PSS)

    It is designed to measure how stressful individuals perceive their experiences, including their feelings and thoughts that they may have experienced during the last month. The total score that can be obtained from the scale is 32. The scale consists of 8 items. These items are scored by the individual in a 5-point Likert type (0=Never,1=Rarely,2=Sometimes,3=Frequently, 4=Very often) according to their intensity of experience. While five items of the scale are plain (1st, 2nd, 3rd, 7th, 8th items); three items are reversed (items 4, 5, 6). It has two subscales: perceived stress (1st, 2nd, 3rd, 7th, 8th items) and perceived coping (4th, 5th, 6th items).

    after 1 hour in mandala app

  • State-Trait Anxiety Inventory (WHO)

    n this study, the part of the scale measuring trait anxiety was used to determine the trait anxiety levels of the patients. Trait Anxiety Inventory is a 4-point Likert-type with 20 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the degree of severity of the feelings, thoughts or behaviors expressed by the items. . There are direct or reverse scored statements in the scale. Reverse scored statements; Items 1, 6, 7, 10, 13, 16 and 19. Trait anxiety score is obtained by adding the constant value of 35, which is the constant value of the trait anxiety scale, to the value obtained by subtracting the total score of the reverse scored statements from the total score of the direct statements. The lowest score that can be obtained from the scale is 20, and the highest score is 80. A high score indicates a high level of anxiety, a low score indicates a low level of anxiety.

    after 1 hour in mandala app

  • SF-36 Quality of Life Scale

    The scale consists of 36 questions and consists of physical functionality (10 questions), social functionality (2 questions), physical role restrictions (4 questions), emotional role restrictions (3 questions), mental health (5 questions), energy/vitality (4 questions), pain (2 questions), general health perception (5 questions). The answers to the questions are in 2, 3, 5, and 6 point likert type. Scoring of the scale takes place in two stages. In the first stage, 0 represents the lowest quality of life value and 100 represents the highest quality of life value. In the second stage, scores for each dimension are obtained. A score close to 0 indicates undesirable poor health, and closer to 100 indicates desired good health.

    after 1 hour in mandala app

Study Arms (2)

mandala app

EXPERIMENTAL

mandala will be aplicated

Behavioral: Perceived Stress, Mandala application

routine maintenance practice

NO INTERVENTION

Routine maintenance will be applied.

Interventions

Mandala

Also known as: Anxiety Level, Quality of Life
mandala app

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be over 18 years old
  • Palliative care patient being the only informal caregiver
  • There is no physical problem that will prevent painting mandala. (seeing, hearing, etc.)
  • Being able to use their hands actively
  • No communication problem
  • No learning problems
  • Being suitable/willing to work with the group

You may not qualify if:

  • be under the age of 18
  • Palliative care patient is not the only informal caregiver
  • Having a physical problem that will prevent you from painting a mandala (sight, hearing, etc.)
  • Having a physical disability in the upper extremity of the caregiver
  • Having trouble communicating
  • Having a learning problem
  • It does not show the harmony of working with the group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gülcan B.Turan

Elâzığ, Merkez, 23000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant) Perceived Stress, Anxiety Level and Quality of Life
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Mandala
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

April 25, 2023

Primary Completion

September 30, 2023

Study Completion

November 30, 2023

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations