Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05488717
Status:
COMPLETED
Last Update Posted:
2022-08-08
First Post:
2022-03-01
Brief Title:
The Effect of Art-Based Mandala on Mental Health in Bone Marrow Transplant Patients
Sponsor:
Aysenur Uceriz
Organization:
Istanbul University
Study Overview
Official Title:
The Effect of Art-Based Mandala on Mental Health in Bone Marrow Transplant Patients
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10000 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 persons 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
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 10000 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 persons 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
Detailed Description:
There is a limited number of studies it is emphasized that art-based applications should be used as a complementary medicine method in cancer patients nurses who have the most contact with patients in the care dimension use art-based applications to diagnose and control the symptoms The aim of this study is to investigate the effect of art-based mandala on mental health in CIS patients who are cancer patient groups
The research will be carried out at Istanbul University Istanbul Faculty of Medicine Department of Internal Medicine Hematology Department Bone Marrow Service and Autologous Transplantation Unit
Bone Marrow Service which has a six-bed and isolated service feature has 1 specialist doctor 1 assistant doctor and 10 clinical nurses and an average of 18 allogenic bone marrow transplants are performed annually
The twelve-bed Autologous Transplant Unit has 2 specialist doctors and 11 clinical nurses and an average of 28 autologous transplants occur annually Post-discharge complications are also monitored in the unit which is not isolated service
The study will be conducted between 15 January 2022 and 31 December 2022 The GPower 31 program was used for power analysis calculations of the experimentally designed study Taking into account Dogans work which is similar to the purpose and design of the study the experimental groups desperation pretest score average of 505 372 to determine the sample size final test score average 259 19 α margin of error 005 and 1- β power 080 In this way the sample size was calculated as 42 however taking into account factors such as not participating in the study leaving the study etc design effect11 and the final sample size was determined as 46 46 patients to be included in the study It was randomized with the IBM SPSS v21 package programThe data will be collected with Patient Information Form External Thermometer Spielberger Continuous Anxiety Inventory Beck Desperation Scale and Diener Psychological Well-Being Scale
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
analysis of quantitative data obtained from the research will be done using IBM SPSS v21 package program For descriptive statistics for variables mean standard deviation number n percentage representation and square-square test will be used for relationships between categorical variables All analyses will be evaluated in a 95 reliability range P005 criteria will be taken for meaningfulness in all statistical analyses
If the evaluation of both the experiment and the control group in the first interview the comparison of evaluation scores before and after transplantation is provided with the assumption of normality single-factor repetitive measurements are paired ANOVA test if the assumption of normality is not provided it will be examined by the Friedman test
Permission will be obtained from the Scientific Research and Publication Ethics Board of Sabahttin Zaim University in Istanbul in order to carry out the research The necessary permission will be obtained from the Department of Hematology of istanbul University Istanbul Faculty of Medicine Department of Internal Medicine where the research will be carried out Those who are willing to participate in the study will be informed before the study and written consent will be obtained from the individuals Since personal data will be collected in the research all necessary measures will be taken to protect personal data in accordance with the Personal Data Protection Law No 6698 and related legislation and all necessary obligations will be carefully fulfilled
The research will be carried out at Istanbul University Istanbul Faculty of Medicine Department of Internal Medicine Hematology Department Bone Marrow Service and Autologous Transplantation Unit
Bone Marrow Service which has a six-bed and isolated service feature has 1 specialist doctor 1 assistant doctor and 10 clinical nurses and an average of 18 allogenic bone marrow transplants are performed annually
The twelve-bed Autologous Transplant Unit has 2 specialist doctors and 11 clinical nurses and an average of 28 autologous transplants occur annually Post-discharge complications are also monitored in the unit which is not isolated service
The study will be conducted between 15 January 2022 and 31 December 2022 The GPower 31 program was used for power analysis calculations of the experimentally designed study Taking into account Dogans work which is similar to the purpose and design of the study the experimental groups desperation pretest score average of 505 372 to determine the sample size final test score average 259 19 α margin of error 005 and 1- β power 080 In this way the sample size was calculated as 42 however taking into account factors such as not participating in the study leaving the study etc design effect11 and the final sample size was determined as 46 46 patients to be included in the study It was randomized with the IBM SPSS v21 package programThe data will be collected with Patient Information Form External Thermometer Spielberger Continuous Anxiety Inventory Beck Desperation Scale and Diener Psychological Well-Being Scale
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
analysis of quantitative data obtained from the research will be done using IBM SPSS v21 package program For descriptive statistics for variables mean standard deviation number n percentage representation and square-square test will be used for relationships between categorical variables All analyses will be evaluated in a 95 reliability range P005 criteria will be taken for meaningfulness in all statistical analyses
If the evaluation of both the experiment and the control group in the first interview the comparison of evaluation scores before and after transplantation is provided with the assumption of normality single-factor repetitive measurements are paired ANOVA test if the assumption of normality is not provided it will be examined by the Friedman test
Permission will be obtained from the Scientific Research and Publication Ethics Board of Sabahttin Zaim University in Istanbul in order to carry out the research The necessary permission will be obtained from the Department of Hematology of istanbul University Istanbul Faculty of Medicine Department of Internal Medicine where the research will be carried out Those who are willing to participate in the study will be informed before the study and written consent will be obtained from the individuals Since personal data will be collected in the research all necessary measures will be taken to protect personal data in accordance with the Personal Data Protection Law No 6698 and related legislation and all necessary obligations will be carefully fulfilled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Interventional research | OTHER | Istanbul Sabahattin Zaim University | None |