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The Effect of Mandala Coloring Applied to Caregivers Caring for Palliative Care Patients on Perceived Stress, Anxiety Level, and Quality of Life

Primary Purpose

Perceived Stress, Anxiety Level, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Perceived Stress, Mandala application
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Perceived Stress

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Gülcan B.TuranRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mandala app

routine maintenance practice

Arm Description

mandala will be aplicated

Routine maintenance will be applied.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
April 25, 2023
Last Updated
May 10, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05847231
Brief Title
The Effect of Mandala Coloring Applied to Caregivers Caring for Palliative Care Patients on Perceived Stress, Anxiety Level, and Quality of Life
Official Title
The Effect of Mandala Coloring Applied to Caregivers Caring for Palliative Care Patients on Perceived Stress, Anxiety Level, and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
January 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The palliative care approach first emerged in the 11th century as a religious-based volunteer movement for the treatment of people suffering from terminal illnesses during long journeys. Although the quality of patient care changes all over the world, there is definitely a section in care that includes the responsibilities of the family. It is stated in the literature that the anxiety levels of the patient and family members who receive the necessary information and support about the disease decrease. The caregiving process is a very stressful situation for the caregiver, which can lead to physical and psychological problems. Anxiety levels of caregivers also increase due to the caregiving process that creates excessive stress and anxiety. Studies in which caregivers have high levels of anxiety due to the burden of care come to the fore in the literature. Mandala provides calming and relaxation as your mind. It silences the negative and complex emotions that bother the person himself. With the relaxation it provides, it allows the individual to listen to himself and to rest spiritually. Mandala allows to see holistically. While increasing one's awareness, it reveals what is hidden in the unconscious. Art therapy helps individuals feel themselves at the center of their lives, express themselves and discover who they are in the group while drawing, painting or making mandalas. Jung stated that he created mandalas in times of distress when both he and his patients felt negative emotions. İn the previous studies; Mandala art therapy has been used to define psychiatric problems in children, to reduce stress and to calm down, to provide concentration and psychological relaxation, and positive results have been obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perceived Stress, Anxiety Level, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Mandala
Masking
Participant
Masking Description
Single (Participant) Perceived Stress, Anxiety Level and Quality of Life
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mandala app
Arm Type
Experimental
Arm Description
mandala will be aplicated
Arm Title
routine maintenance practice
Arm Type
No Intervention
Arm Description
Routine maintenance will be applied.
Intervention Type
Behavioral
Intervention Name(s)
Perceived Stress, Mandala application
Other Intervention Name(s)
Anxiety Level, Quality of Life
Intervention Description
Mandala
Primary Outcome Measure Information:
Title
Perceived Stress Scale (PSS)Perceived Stress Scale (PSS)
Description
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).
Time Frame
after 1 hour in mandala app
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (WHO)
Description
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.
Time Frame
after 1 hour in mandala app
Other Pre-specified Outcome Measures:
Title
SF-36 Quality of Life Scale
Description
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.
Time Frame
after 1 hour in mandala app

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gülcan B.TURAN, PHD
Phone
05065576086
Email
glcnbah@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma GÜRCAN, STD
Phone
05438433879
Email
F.gurcan1@gmail.com
Facility Information:
Facility Name
Gülcan B.Turan
City
Elazığ
State/Province
Merkez
ZIP/Postal Code
23000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Gürcan

12. IPD Sharing Statement

Learn more about this trial

The Effect of Mandala Coloring Applied to Caregivers Caring for Palliative Care Patients on Perceived Stress, Anxiety Level, and Quality of Life

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