Mental HealthNCT05488717
The Effect of Art-Based Mandala on Mental Health in Bone Marrow Transplant Patients
A study testing art-based mandala application in people with Mental Health and Bone Marrow Cancer, run by Aysenur Uceriz at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Bone Marrow Cancer, ART
- What is being tested?
- art-based mandala application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to 15 May 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 .
Read more
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 .
Read the 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 G*Power 3.1 program was used for power analysis calculations of the experimentally designed study. Taking into account Dogan's work, which is similar to the purpose and design of the study; the experimental group's desperation pretest score average of 5.05 (±3.72) to determine the sample size; final test score average 2.59 (±1.9); α margin of error: 0.05 and 1- β (power): 0.80. 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 effect:1.1 and the final sample size was determined as 46. 46 patients to be included in the study; It was randomized with the IBM SPSS v.21 package program.The 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 v.21 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. P<0.05 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.
- Conditions
- Mental Health, Bone Marrow Cancer, ART
- Being tested
- art-based mandala application
- Medical subject headings
- Psychological Well-Being, Bone Marrow Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
art-based mandala applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: art-based mandala application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
patient information form
It is a questionnaire consisting of 11 questions prepared by the researcher, including sociodemographic and medical information.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start15 Jan 2022
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysenur Uceriz
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Sabahattin Zaim University
- Responsible party
- Sponsor-investigator, Aysenur Uceriz, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488717
- Sponsor's protocol ID
- Master's thesis
- Other IDs
- Interventional research
- Status last verified
- Aug 2022
- First submitted
- 1 Mar 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Art-Based Mandala on Mental Health in Bone Marrow Transplant Patients
- ClinicalTrials.gov ID
- NCT05488717
- Acronym / sponsor ID
- Master's thesis
- Conditions
- Mental Health, Bone Marrow Cancer, ART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Aysenur UcerizUniversity, hospital or other
- Collaborators
- Istanbul Sabahattin Zaim University
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 4 Aug 2022 (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.
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 .
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 G*Power 3.1 program was used for power analysis calculations of the experimentally designed study. Taking into account Dogan's work, which is similar to the purpose and design of the study; the experimental group's desperation pretest score average of 5.05 (±3.72) to determine the sample size; final test score average 2.59 (±1.9); α margin of error: 0.05 and 1- β (power): 0.80. 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 effect:1.1 and the final sample size was determined as 46. 46 patients to be included in the study; It was randomized with the IBM SPSS v.21 package program.The 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 v.21 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. P<0.05 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Application | Experimental | Other: art-based mandala applicationPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| art-based mandala applicationPatients 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 | Application |
Primary outcome
Distress Thermometer
Time frame: through study completion, an average of 1 year
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.
State/ Trait Anxiety Inventory-STAI
Time frame: through study completion, an average of 1 year
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.
Beck Hopelessness Scale
Time frame: through study completion, an average of 1 year
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.
Psychological Well-Being Scale (PIOS)
Time frame: through study completion, an average of 1 year
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.
1 secondary outcome
patient information form
Time frame: through study completion, an average of 1 year
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 8 Aug 2022.
- Individual participant dataSharing planned: Yes
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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 art-based mandala application in people with Mental Health and Bone Marrow Cancer, run by Aysenur Uceriz 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 0 inclusion and 6 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 8 Aug 2022. 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?
Distress Thermometer (time frame: through study completion, an average of 1 year). The study lists 4 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 8 Aug 2022.