Perceived StressNCT05847231
The Effect of Mandala Coloring Applied to Caregivers Caring for Palliative Care Patients on Perceived Stress, Anxiety Level, and Quality of Life
A study testing Perceived Stress, Mandala application in people with Perceived Stress and Anxiety Level, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Perceived Stress, Anxiety Level, Quality of Life
- What is being tested?
- Perceived Stress, Mandala application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2023to 30 Nov 2023
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Perceived Stress, Anxiety Level, Quality of Life
- Being tested
- Perceived Stress, Mandala application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceived Stress, Mandala applicationBehavioural
Also called Anxiety Level, Quality of Life
Mandala
| Study group | Role | What they receive |
|---|---|---|
| mandala app | Experimental | mandala will be aplicated Receives: Behavioral: Perceived Stress, Mandala application |
| routine maintenance practice | No intervention | Routine maintenance will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: after 1 hour in mandala app
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start25 Apr 2023
- Primary completion30 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perceived StressStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- Mandala
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847231
- Sponsor's protocol ID
- 2023/ 05- 08
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2023
- Last updated
- 1 Apr 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring Applied to Caregivers Caring for Palliative Care Patients on Perceived Stress, Anxiety Level, and Quality of Life
- ClinicalTrials.gov ID
- NCT05847231
- Acronym / sponsor ID
- 2023/ 05- 08
- Conditions
- Perceived Stress, Anxiety Level, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 6 May 2023 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Mandala
| Arm | Type | Receives |
|---|---|---|
| mandala app | Experimental | Behavioral: Perceived Stress, Mandala applicationmandala will be aplicated |
| routine maintenance practice | No intervention | –Routine maintenance will be applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Perceived Stress, Mandala applicationAlso: Anxiety Level, Quality of LifeMandala | Behavioural | mandala app |
Primary outcome
Perceived Stress Scale (PSS)Perceived Stress Scale (PSS)
Time frame: after 1 hour in mandala app
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).
State-Trait Anxiety Inventory (WHO)
Time frame: after 1 hour in mandala app
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.
SF-36 Quality of Life Scale
Time frame: after 1 hour in mandala app
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.
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 1 Apr 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 Perceived Stress, Mandala application in people with Perceived Stress and Anxiety Level, run by Ataturk 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 7 inclusion and 7 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 1 Apr 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?
Perceived Stress Scale (PSS)Perceived Stress Scale (PSS) (time frame: after 1 hour in mandala app). The study lists 3 primary outcomes in all. 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 1 Apr 2026.