The Effect of Art-Based Mandala on Mental Health in Bone Marrow Transplant Patients
2 other identifiers
interventional
46
1 country
1
Brief Summary
According to the World Health Organization (WHO), health is not only a state of complete well-being in terms of illness and disability, but also physical mental and social well-being. Mental health, on the other hand, is a state of goodness in which the individual is aware of his own abilities, copes with the normal tensions of life, can work productively and efficiently and contributes to the society in which he lives. It has been shown in many studies that mental health problems negatively affect the existing disease process. For example, research shows an association between depression and anxiety and cardiovascular and cerebrovascular diseases . In the New York Health Survey, 10,000 individuals representing 33 communities were surveyed by phone; it was found that the general health status of people who reported significant emotional distress was three times worse than those who did not report it . Realizing that mental health is more than just a disease will guide individuals and caregivers. Developing a more comprehensive clinical approach by focusing on a person's healthy, strengths, abilities and personal efforts is important in strengthening mental health. Applications for strengthening mental health include improving nutrition and housing conditions, increasing access to education, strengthening social networks, creating support environments. In the acceptance and stability therapy study of Bash and Dirik with cancer, it was determined that the negative psychological symptoms of the patients decreased and their expectations of life and quality of life increased. In another study , it was determined that the spiritual support practices provided to 150 individuals with breast cancer positively affected the state of spiritual, psychological and physical well-being. Cancer is a life-threatening disease that is common all over the world and affects the individual both physically and psychologically. Hematologic cancers are caused by bone marrow, the place of production of blood, and include diseases such as acute-chronic leukemias and multiple myelomas. Chemotherapy, radiotherapy, surgical methods in the treatment of hematologic cancers; hormonal and biological treatment and bone marrow transplantation (CIS) may be preferred. Among the applications aimed at strengthening mental health are art-based applications (music therapy, applications for visual arts-painting, painting, mandala, clay works, etc.), collage, carving, sculpture, poetry therapy, etc.) as subheadings for the creation of supportive environments. we come across it. When the literature is examined, it is stated that the participation of individuals with art-based applications increases the adaptation process, helps them to find the meaning of life, increases their awareness of cancer and their life, is better adapted to disease and treatment, their emotional expression is more effective, and the state of spiritual and psychological well-being improves positively . Art-based applications provide a significant reduction in anxiety levels in adult cancer patients ; health-related quality of life . In other studies with cancer patients, it was found that art therapy practices reduce the feeling of anxiety and depression and cause a significant increase in health-related quality of life, patients feel more valued and strong, self-esteem increases, interpersonal relationships develop and they are more social .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
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, 2022
CompletedFirst Submitted
Initial submission to the registry
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2022
CompletedFirst Posted
Study publicly available on registry
August 4, 2022
CompletedAugust 8, 2022
August 1, 2022
4 months
March 1, 2022
August 4, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Distress Thermometer
stress It is a visual analog scale in the form of a thermometer with numbers from 0 to 10. The scale is a 3-level thermometer scoring 0-10, and the patient is asked to indicate how much pressure they have felt during the past week; A score of 4 or above indicates that the patient has clinically significant distress.
through study completion, an average of 1 year
State/ Trait Anxiety Inventory-STAI
trait anxiety 7 of the trait anxiety statements (1, 6, 7, 10, 13, 16, 19) were correct, 13 (2, 3, 4, 5, 8, 9, 11, 12, 14, 15, 17, 18) , 20) is the opposite expression. While the reverse expressions expressing positive emotions are scored, those with a weight of 1 are converted to 4, and those with a weight of 4 are converted to 1. In direct statements expressing negative emotions, responses with a value of 4 indicate the height of anxiety. In the evaluation, the total score of the negative statements is subtracted from the total score of the positive statements, and a constant number of 35 is added to the value found. The resulting score; A score of 0-19 is considered no anxiety, a score of 20-39 is mild anxiety, 40-59 is moderate anxiety, 60-79 is severe anxiety, and a score of 80 and above is considered panic and crisis.
through study completion, an average of 1 year
Beck Hopelessness Scale
Hopelessness The scale used to evaluate the hope and hopelessness status of the individual includes 20 statements with yes and no response options. The answer given to 11 items in the scale was yes (2, 4, 7, 9, 11, 12, 14, 16, 17, 18, 20. statements), and the answer to 9 items was no (1, 3, 5, 6, 8, 10, 13, 15, 19. phrases) are expected. A score of 1 is given if an expected response is given to each statement, and 0 is given if an unexpected response is given. The total score of the scale, ranging from 0 to 20, is determined by summing up the answers; A low score indicates a high level of hope, conversely, a high score indicates a low level of hope.
through study completion, an average of 1 year
Psychological Well-Being Scale (PIOS)
psychological well-being All items in the scale are expressed positively; Each item is answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). The score obtained ranges from 8 (strongly disagree to all items) to 56 (strongly agree to all items). A high score indicates that the person has many psychological resources and strength, in other words, the level of psychological well-being is high.
through study completion, an average of 1 year
Secondary Outcomes (1)
patient information form
through study completion, an average of 1 year
Study Arms (1)
Application
EXPERIMENTALPatients who are routinely scheduled for bone marrow transplantation are admitted to the unit one week before the transplant and treatment is started and transplantation is performed a week later. All patients in the intervention and control group will be filled out forms upon hospitalization after receiving their informed consent at the beginning of the study. Subsequently, patients in the intervention group will be given art-based mandala painting, which is sampled below, for 30 minutes for a week, accompanied by instrumental music featuring natural sounds in a room with light-heat control. Mandala painting templates and crayons will be provided by the researcher. The researcher will not intervene in any way other than time management during the preparation and painting of the environment. The researcher participated in training on art-based mandala and made preliminary preparations. No intervention will be made to the control group except for routine clinical applications.
Interventions
Patients who are routinely scheduled for bone marrow transplantation are admitted to the unit one week before the transplant and treatment is started and transplantation is performed a week later. All patients in the intervention and control group will be filled out forms upon hospitalization after receiving their informed consent at the beginning of the study. Subsequently, patients in the intervention group will be given art-based mandala painting, which is sampled below, for 30 minutes for a week, accompanied by instrumental music featuring natural sounds in a room with light-heat control. Mandala painting templates and crayons will be provided by the researcher. The researcher will not intervene in any way other than time management during the preparation and painting of the environment. The researcher participated in training on art-based mandala and made preliminary preparations. No intervention will be made to the control group except for routine clinical applications.
Eligibility Criteria
You may not qualify if:
- not be between the ages of 18-65
- Not being hospitalized for the bone marrow transplant process
- Having any psychiatric diagnosis
- Having a physical disability to paint mandalas
- Not being literate enough to fill in the scales
- to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aysenur Ucerizlead
- Istanbul Sabahattin Zaim Universitycollaborator
Study Sites (1)
Istanbul University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 1, 2022
First Posted
August 4, 2022
Study Start
January 15, 2022
Primary Completion
May 15, 2022
Study Completion
May 15, 2022
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share