NCT05488717

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

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

March 1, 2022

Last Update Submit

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

EXPERIMENTAL

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.

Other: art-based mandala application

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.

Application

Eligibility Criteria

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

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

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-BeingBone Marrow Neoplasms

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorHematologic NeoplasmsNeoplasms by SiteNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

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

Locations