Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06192121
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2023-12-20
Brief Title:
Web-Based Education for Individuals With Type-2 Diabetes
Sponsor:
Near East University Turkey
Organization:
Near East University Turkey
Study Overview
Official Title:
The Effect of Self-Care Disability Theory-Based Web-Based Education for Individuals With Type-2 Diabetes on Care Outcomes
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Type-2DM
Brief Summary:
Type and Aim of Research This research will be conducted as a randomised controlled experimental study design to test the effect of web-based diabetes education on the quality of life and self-care activities of individuals with Type 2 Diabetes
Place and Time of the Study This research will be conducted between September 2023 and March 2024 with individuals registered to the Cyprus Turkish Diabetes Association
Population and Sample of the Study The population of the study consisted of individuals with Type-2 diabetes who applied to the Cyprus Turkish Diabetes Centre The sample of the study included individuals with type-2 diabetes who met the inclusion criteria at the Turkish Cypriot Diabetes Centre
Sample size was calculated using G Power statistical programme n74
In order to evaluate the effectiveness in the experimental and control groups simple randomisation was performed to ensure the similarity of the two groups Randomisation was applied after the pre-tests
The data of the study will be collected by Sociodemographic Data Form Diabetes Specific Quality of Life Scale Diabetes Self-Care Activities Questionnaire Website Analysis and Measurement Inventory The forms will be applied to the participants face to face
People in the experimental group whose information was sent to the researcher will receive reminder messages twice a week Wednesday-Friday during the 3-month follow-up period via the website No intervention will be applied to the control group The post-test will be applied
Place and Time of the Study This research will be conducted between September 2023 and March 2024 with individuals registered to the Cyprus Turkish Diabetes Association
Population and Sample of the Study The population of the study consisted of individuals with Type-2 diabetes who applied to the Cyprus Turkish Diabetes Centre The sample of the study included individuals with type-2 diabetes who met the inclusion criteria at the Turkish Cypriot Diabetes Centre
Sample size was calculated using G Power statistical programme n74
In order to evaluate the effectiveness in the experimental and control groups simple randomisation was performed to ensure the similarity of the two groups Randomisation was applied after the pre-tests
The data of the study will be collected by Sociodemographic Data Form Diabetes Specific Quality of Life Scale Diabetes Self-Care Activities Questionnaire Website Analysis and Measurement Inventory The forms will be applied to the participants face to face
People in the experimental group whose information was sent to the researcher will receive reminder messages twice a week Wednesday-Friday during the 3-month follow-up period via the website No intervention will be applied to the control group The post-test will be applied
Detailed Description:
The Effect of Self-Care Disability Theory-Based Web-Based Education for Individuals with Type-2 Diabetes on Care Outcomes
Purpose of the Study The aim of this study is to determine the effect of web-based diabetes education developed on the basis of self-care deficiency on individuals quality of life and self-care activities
Hypotheses of the Study
H0 There is no difference between the total mean score of the Diabetes Specific Quality of Life scale between the experimental and control groups of the Web-based diabetes education programme prepared on the basis of the Self-Care Disability Theory
H0 There is no difference between the mean scores of the Diabetes Self-Care Activities scale between the experimental and control groups of the Web-based diabetes education programme prepared on the basis of the Self-Care Disability Theory
METHOD
Type of Research This research will be conducted as a randomised controlled experimental study design to test the effect of web-based diabetes education on the quality of life and self-care activities of individuals with Type 2 Diabetes
Place and Time of the Study This research will be conducted between September 2023 and March 2024 with individuals registered to the Cyprus Turkish Diabetes Association
Population and Sample of the Study The population of the study consisted of individuals with Type-2 diabetes who applied to the Cyprus Turkish Diabetes Centre The sample of the study included individuals with type-2 diabetes who met the inclusion criteria at the Turkish Cypriot Diabetes Centre
Cyprus Turkish Diabetes Association The Cyprus Turkish Diabetes Association was established in Nicosia in 1994 The aim of the association is to improve the quality of life of diabetics and their relatives and to increase awareness of diabetes Among the visions published by the association freeing people from the restrictions of diabetes providing the highest quality care and information to everyone ending ignorance and discrimination gaining an international understanding of diabetes and its organisations and creating a world without diabetes
Research Criteria
Inclusion Criteria
Literate in Turkish
With access to the Internet
Diagnosed with Type II Diabetes
Mental competence
Individuals who volunteered to participate in the study were included
Exclusion Criteria
Cannot use a computer or smartphone
Under 18 years of age
With Type 1 Diabetes
Working in the field of health and receiving health education in any field
Individuals who participated in the pre-application were not included in the study
Calculation of Sample Size Sample size was calculated using G Power statistical programme In order to reach the minimum and maximum sample numbers to be sampled it is stated that the effect sizes of these studies should be determined from the mean and standard deviation levels of the intervention and control groups obtained from the scales obtained from previous similar studies The effect size of Wu which is the closest study to our study was found to be 070 in his study n145 conducted with the Diabetes Self-Care Activities Questionnaire in individuals with diabetes As a result of the calculation made by taking 90 power and 005 error margin as well as the effect sizes obtained from the studies for the sample size the sample number for each of the intervention and control groups for our study was determined as 36 individuals in each group according to the Diabetes Self-Care Activities Questionnaire with an effect size of 070 According to these results a total of 72 patients 36 intervention and 36 control should be included in the intervention and control groups However the sample was increased by 10 against the possibility of sample loss during the study and the sample of the study was initially determined as a total of 80 patients 40 intervention and 40 control
Randomization In order to evaluate the effectiveness in the experimental and control groups randomization was performed to ensure the similarity of the two groups By choosing the simple randomization method an equal number of samples experiment 40 control 40 were provided for the experimental and control groups After informed consent and pretests are completed assignments to groups will be made by a different instructor in order to avoid bias Assignment to groups will be done using the simple randomization method using the web program and the closed envelope method with a simple table of numbers The group the individual will be in will be communicated to the researcher in a sealed envelope before the intervention
Blinding Blinding will be done in data collection statistics and reporting in the research In the research after obtaining pre-test data randomization and data entry pre- and post-tests and data transfer to the computer will be carried out by a nursing faculty member other than the researcher who is unaware of the experimental and control groups Data entries were entered with the code A and B without specifying the experimental or control group Data analysis and writing of the research report will be coded as A and B groups After the statistical analysis is performed and the research report is written the coding for the experimental and control groups will be explained to the researcher by the coder
Data Collection Tools Data of the research It will be collected with the Sociodemographic Data Form Diabetes-Specific Quality of Life Scale Diabetes Self-Care Activities Survey Website Analysis and Measurement Inventory The forms will be administered to participants face to face
Socio-demographic Data Form The socio-demographic questionnaire prepared by the researchers after literature review consists of 23 questions that determine the characteristics of individuals such as age gender and educational status
Diabetes-Specific Quality of Life Scale The Diabetes-Specific Quality of Life Scale defined by Jacobson consists of four subscales and 46 items psychological satisfaction with treatment psychological impact diabetes-related anxiety and socialoccupational anxiety Each item in the scale is scored between 1-5 points In the dimension of psychological satisfaction with the treatment questions 22-24 the answer very satisfied is calculated as 1 point the answer very dissatisfied is calculated as 5 points while in the other dimensions the answer never is calculated as 1 point and the answer always is calculated as 5 points The total score of the scale varies between 46-230 The total scale score and each subscale score are divided by the number of items and the scores of 1 are converted into 5 points to obtain the total scale score According to the scale total scores high scores indicate good quality of life Subscale Cronbachs alpha values of the original scale are between 066 and 092 and the test-retest value is 078 and 092 A Turkish validity and reliability study of the scale was conducted by Yıldırım The total Cronbach alpha value of the scale was found to be 089 and the Cronbach alpha values for the subscales were found to be between 080-094
Diabetes Self-Care Activities Survey The Diabetes Self-Care Activities Questionnaire was developed by Toobert In the survey individuals It is asked how many days daysweek in the last seven days the patient performed self-care activities under the headings of diet exercise blood sugar test foot care and smoking The answers are marked as days 0-7 on a number line and the 11th item which only questions smoking is stated as 0 - I do not smoke 1 - I smoke amountpiece of cigarettes smoked Each subscale of the scale is scored separately and can be used independently
The Turkish validity and reliability study of the scale was conducted by Coşansu
Website Analysis and Measurement Inventory
Website Analysis and Measurement Inventory WAMMI is a scale based on usability and software evaluation for international software standards WAMMI is used to evaluate web sites in many areas It has translations in many European languages The inventory measures attractiveness controllability It includes the sub-dimensions of efficiency helpfulness learnability and global usability WAMMI scores are expressed as a percentage the higher the percentage the more useful the website is The average score is calculated as the numerical average of the individual scores scored by the participants Standard deviation variability in the data A reasonable value for standard deviation for this type of data is 20 If all participants have a common opinion about website evaluations the standard deviation is expected to be smaller If participants have different opinions the standard deviation is much larger with a standard deviation above 30 deviation indicates that there are two or more groups of participants with very different opinions about the usability of the website
Application of Research
During the implementation of the research first of all 181 people who applied to the Turkish Cypriot Diabetes Association were reached by the researcher Among the 101 people reached 76 people were not included in the study because they had type 1 diabetes 14 people could not use a computer or smartphone 4 people were healthcare workers 3 people did not agree to participate in the research and 4 people were not mentally competent n 80 As part of the pre-test the sociodemographic questionnaire diabetes-specific quality of life scale and diabetes self-care activities scale were applied to the participants
In order to carry out the randomization of the determined research sample help was received from another researcher and the Simple Randomization Method was applied and the information of the individuals in the experimental n 40 and control n 40 groups was conveyed to the researcher
The website was installed on the phones of the people in the experimental group whose information was forwarded to the researcher
During the 3-month follow-up period reminder messages will be sent to individuals in the experimental group twice a week Wednesday-Friday while no intervention will be applied to the control group
In order to prevent bias within the scope of the post-test the post-test data of the participants will be obtained with the help of an expert researcher in the field through appointments made at the Turkish Cypriot Diabetes Center While the diabetes-specific quality of life scale and diabetes self-care activities survey will be applied to the control group website analysis and measurement inventory will also be applied to the control group unlike these surveys
After the research is completed the control group will be informed about the website and they will be able to benefit from the website
Applications for Web-Based Training Program Development The training program development process which was methodologically planned for the purpose of the research to develop a training program for individuals with Type 2 diabetes is explained below
Web designing
The following steps were followed during web design
Editing the topics and content of the website Todays national and international websites existing training booklets current literature meta-analyses systematic reviews original articles books and current guides used in this field were used
The content of the website is Public Health Nursing Lecturer 4 people Internal Medicine Nursing Lecturer 1 person Diabetes Education Nurses 1 person Mental Health and Diseases Lecturer 2 people and Dietetics and Nutrition Department Lecturer It was evaluated by 1 person and edited with topic suggestions
The website is designed to be mobile compatible
Website The website address is wwwkibrisdiyabethemsireligicom The website has been prepared in parallel with the information provided in the literature and expert opinions It is supported with videos pictures interactive forms e-mail help and contact information
After the preparation of the website it was evaluated by 5 researchers and 2 software experts who work in the field of web-based education
Website Pre-Application
In order to test the understandability of the website for patients a preliminary application was carried out at the Turkish Cypriot Diabetes Association between July and August 2023 for 10 individuals diagnosed with type 2 diabetes
In the first interview with individuals who meet the research inclusion criteria and agree to participate in the research
As part of the pretest the Sociodemographic Questionnaire Diabetes-Specific Quality of Life Scale and Diabetes Self-Care Activities Survey were administered by the researcher
A username and password were created by the researcher to log in to the website
Participants were explained how to log in to the website by logging in with the username and password given to them on the computer in the room used
Information was provided about the home page of the website basic topics how to view the content how to access it and videos and games
It was explained that they should read the website for at least two hours a week examine all sections and give feedback after two weeks
They were informed that they could contact the researcher 247 by e-mail andor telephone if they had any problems regarding the website
This entire information process and filling out the data collection forms took 25 minutes
Two weeks after the first interview the individuals included in the pre-application were administered the Website Analysis and Measurement Inventory Scale within the scope of the post-test at the Turkish Cypriot Diabetes Center
After the pre-application the question Do you have sufficient knowledge about diabetes in the Socidemographic Questionnaire and Do you experience anxiety regarding insulin therapy The I am undecided option has been added to the questions No changes were made to the scales
Individuals who were included in the preliminary application were not included in the scope of the research
After the research was completed the username and passwords given for the preliminary application were cancelled Individuals included in the pre-application were informed that the permanent address of the website would be sent to them via SMS
Ethical Aspect of Research Necessary ethical permissions to conduct the research were obtained from Near East University and Turkish Cypriot Diabetes Association In addition for the use of scales in the research Assoc Prof for the Diabetes Self-Care Activities Survey Dr From Gülhan Coşansudan Prof for the Diabetes-Specific Quality of Life Scale Dr Written consent was obtained from Ayşegül Kaptanoğlu the researchers and the individuals participating in the research
Limitations of the Research The scope of the research
Individuals who have internet connection at home or have internet on their mobile phone
Evaluation of only three-month effects
One of the limitations of the study is that it is based on self-report Research Variables
Independent variables
Sociodemographic characteristics of the participants
Dependent variables
Participants
Quality of Life Specific to Diabetes
Diabetes Self-Care Activities Scale score averages
Evaluation of Data The data will be evaluated in the SPSS 210 statistical program Frequency and percentage analyzes will be performed for categorical variables and mean and standard deviation analyzes will be performed for continuous variables
In comparing the research variables their suitability for normal distribution will be evaluated and then further statistical analyzes will be carried out The research will be conducted with a 95 confidence interval and a 005 margin of error
Purpose of the Study The aim of this study is to determine the effect of web-based diabetes education developed on the basis of self-care deficiency on individuals quality of life and self-care activities
Hypotheses of the Study
H0 There is no difference between the total mean score of the Diabetes Specific Quality of Life scale between the experimental and control groups of the Web-based diabetes education programme prepared on the basis of the Self-Care Disability Theory
H0 There is no difference between the mean scores of the Diabetes Self-Care Activities scale between the experimental and control groups of the Web-based diabetes education programme prepared on the basis of the Self-Care Disability Theory
METHOD
Type of Research This research will be conducted as a randomised controlled experimental study design to test the effect of web-based diabetes education on the quality of life and self-care activities of individuals with Type 2 Diabetes
Place and Time of the Study This research will be conducted between September 2023 and March 2024 with individuals registered to the Cyprus Turkish Diabetes Association
Population and Sample of the Study The population of the study consisted of individuals with Type-2 diabetes who applied to the Cyprus Turkish Diabetes Centre The sample of the study included individuals with type-2 diabetes who met the inclusion criteria at the Turkish Cypriot Diabetes Centre
Cyprus Turkish Diabetes Association The Cyprus Turkish Diabetes Association was established in Nicosia in 1994 The aim of the association is to improve the quality of life of diabetics and their relatives and to increase awareness of diabetes Among the visions published by the association freeing people from the restrictions of diabetes providing the highest quality care and information to everyone ending ignorance and discrimination gaining an international understanding of diabetes and its organisations and creating a world without diabetes
Research Criteria
Inclusion Criteria
Literate in Turkish
With access to the Internet
Diagnosed with Type II Diabetes
Mental competence
Individuals who volunteered to participate in the study were included
Exclusion Criteria
Cannot use a computer or smartphone
Under 18 years of age
With Type 1 Diabetes
Working in the field of health and receiving health education in any field
Individuals who participated in the pre-application were not included in the study
Calculation of Sample Size Sample size was calculated using G Power statistical programme In order to reach the minimum and maximum sample numbers to be sampled it is stated that the effect sizes of these studies should be determined from the mean and standard deviation levels of the intervention and control groups obtained from the scales obtained from previous similar studies The effect size of Wu which is the closest study to our study was found to be 070 in his study n145 conducted with the Diabetes Self-Care Activities Questionnaire in individuals with diabetes As a result of the calculation made by taking 90 power and 005 error margin as well as the effect sizes obtained from the studies for the sample size the sample number for each of the intervention and control groups for our study was determined as 36 individuals in each group according to the Diabetes Self-Care Activities Questionnaire with an effect size of 070 According to these results a total of 72 patients 36 intervention and 36 control should be included in the intervention and control groups However the sample was increased by 10 against the possibility of sample loss during the study and the sample of the study was initially determined as a total of 80 patients 40 intervention and 40 control
Randomization In order to evaluate the effectiveness in the experimental and control groups randomization was performed to ensure the similarity of the two groups By choosing the simple randomization method an equal number of samples experiment 40 control 40 were provided for the experimental and control groups After informed consent and pretests are completed assignments to groups will be made by a different instructor in order to avoid bias Assignment to groups will be done using the simple randomization method using the web program and the closed envelope method with a simple table of numbers The group the individual will be in will be communicated to the researcher in a sealed envelope before the intervention
Blinding Blinding will be done in data collection statistics and reporting in the research In the research after obtaining pre-test data randomization and data entry pre- and post-tests and data transfer to the computer will be carried out by a nursing faculty member other than the researcher who is unaware of the experimental and control groups Data entries were entered with the code A and B without specifying the experimental or control group Data analysis and writing of the research report will be coded as A and B groups After the statistical analysis is performed and the research report is written the coding for the experimental and control groups will be explained to the researcher by the coder
Data Collection Tools Data of the research It will be collected with the Sociodemographic Data Form Diabetes-Specific Quality of Life Scale Diabetes Self-Care Activities Survey Website Analysis and Measurement Inventory The forms will be administered to participants face to face
Socio-demographic Data Form The socio-demographic questionnaire prepared by the researchers after literature review consists of 23 questions that determine the characteristics of individuals such as age gender and educational status
Diabetes-Specific Quality of Life Scale The Diabetes-Specific Quality of Life Scale defined by Jacobson consists of four subscales and 46 items psychological satisfaction with treatment psychological impact diabetes-related anxiety and socialoccupational anxiety Each item in the scale is scored between 1-5 points In the dimension of psychological satisfaction with the treatment questions 22-24 the answer very satisfied is calculated as 1 point the answer very dissatisfied is calculated as 5 points while in the other dimensions the answer never is calculated as 1 point and the answer always is calculated as 5 points The total score of the scale varies between 46-230 The total scale score and each subscale score are divided by the number of items and the scores of 1 are converted into 5 points to obtain the total scale score According to the scale total scores high scores indicate good quality of life Subscale Cronbachs alpha values of the original scale are between 066 and 092 and the test-retest value is 078 and 092 A Turkish validity and reliability study of the scale was conducted by Yıldırım The total Cronbach alpha value of the scale was found to be 089 and the Cronbach alpha values for the subscales were found to be between 080-094
Diabetes Self-Care Activities Survey The Diabetes Self-Care Activities Questionnaire was developed by Toobert In the survey individuals It is asked how many days daysweek in the last seven days the patient performed self-care activities under the headings of diet exercise blood sugar test foot care and smoking The answers are marked as days 0-7 on a number line and the 11th item which only questions smoking is stated as 0 - I do not smoke 1 - I smoke amountpiece of cigarettes smoked Each subscale of the scale is scored separately and can be used independently
The Turkish validity and reliability study of the scale was conducted by Coşansu
Website Analysis and Measurement Inventory
Website Analysis and Measurement Inventory WAMMI is a scale based on usability and software evaluation for international software standards WAMMI is used to evaluate web sites in many areas It has translations in many European languages The inventory measures attractiveness controllability It includes the sub-dimensions of efficiency helpfulness learnability and global usability WAMMI scores are expressed as a percentage the higher the percentage the more useful the website is The average score is calculated as the numerical average of the individual scores scored by the participants Standard deviation variability in the data A reasonable value for standard deviation for this type of data is 20 If all participants have a common opinion about website evaluations the standard deviation is expected to be smaller If participants have different opinions the standard deviation is much larger with a standard deviation above 30 deviation indicates that there are two or more groups of participants with very different opinions about the usability of the website
Application of Research
During the implementation of the research first of all 181 people who applied to the Turkish Cypriot Diabetes Association were reached by the researcher Among the 101 people reached 76 people were not included in the study because they had type 1 diabetes 14 people could not use a computer or smartphone 4 people were healthcare workers 3 people did not agree to participate in the research and 4 people were not mentally competent n 80 As part of the pre-test the sociodemographic questionnaire diabetes-specific quality of life scale and diabetes self-care activities scale were applied to the participants
In order to carry out the randomization of the determined research sample help was received from another researcher and the Simple Randomization Method was applied and the information of the individuals in the experimental n 40 and control n 40 groups was conveyed to the researcher
The website was installed on the phones of the people in the experimental group whose information was forwarded to the researcher
During the 3-month follow-up period reminder messages will be sent to individuals in the experimental group twice a week Wednesday-Friday while no intervention will be applied to the control group
In order to prevent bias within the scope of the post-test the post-test data of the participants will be obtained with the help of an expert researcher in the field through appointments made at the Turkish Cypriot Diabetes Center While the diabetes-specific quality of life scale and diabetes self-care activities survey will be applied to the control group website analysis and measurement inventory will also be applied to the control group unlike these surveys
After the research is completed the control group will be informed about the website and they will be able to benefit from the website
Applications for Web-Based Training Program Development The training program development process which was methodologically planned for the purpose of the research to develop a training program for individuals with Type 2 diabetes is explained below
Web designing
The following steps were followed during web design
Editing the topics and content of the website Todays national and international websites existing training booklets current literature meta-analyses systematic reviews original articles books and current guides used in this field were used
The content of the website is Public Health Nursing Lecturer 4 people Internal Medicine Nursing Lecturer 1 person Diabetes Education Nurses 1 person Mental Health and Diseases Lecturer 2 people and Dietetics and Nutrition Department Lecturer It was evaluated by 1 person and edited with topic suggestions
The website is designed to be mobile compatible
Website The website address is wwwkibrisdiyabethemsireligicom The website has been prepared in parallel with the information provided in the literature and expert opinions It is supported with videos pictures interactive forms e-mail help and contact information
After the preparation of the website it was evaluated by 5 researchers and 2 software experts who work in the field of web-based education
Website Pre-Application
In order to test the understandability of the website for patients a preliminary application was carried out at the Turkish Cypriot Diabetes Association between July and August 2023 for 10 individuals diagnosed with type 2 diabetes
In the first interview with individuals who meet the research inclusion criteria and agree to participate in the research
As part of the pretest the Sociodemographic Questionnaire Diabetes-Specific Quality of Life Scale and Diabetes Self-Care Activities Survey were administered by the researcher
A username and password were created by the researcher to log in to the website
Participants were explained how to log in to the website by logging in with the username and password given to them on the computer in the room used
Information was provided about the home page of the website basic topics how to view the content how to access it and videos and games
It was explained that they should read the website for at least two hours a week examine all sections and give feedback after two weeks
They were informed that they could contact the researcher 247 by e-mail andor telephone if they had any problems regarding the website
This entire information process and filling out the data collection forms took 25 minutes
Two weeks after the first interview the individuals included in the pre-application were administered the Website Analysis and Measurement Inventory Scale within the scope of the post-test at the Turkish Cypriot Diabetes Center
After the pre-application the question Do you have sufficient knowledge about diabetes in the Socidemographic Questionnaire and Do you experience anxiety regarding insulin therapy The I am undecided option has been added to the questions No changes were made to the scales
Individuals who were included in the preliminary application were not included in the scope of the research
After the research was completed the username and passwords given for the preliminary application were cancelled Individuals included in the pre-application were informed that the permanent address of the website would be sent to them via SMS
Ethical Aspect of Research Necessary ethical permissions to conduct the research were obtained from Near East University and Turkish Cypriot Diabetes Association In addition for the use of scales in the research Assoc Prof for the Diabetes Self-Care Activities Survey Dr From Gülhan Coşansudan Prof for the Diabetes-Specific Quality of Life Scale Dr Written consent was obtained from Ayşegül Kaptanoğlu the researchers and the individuals participating in the research
Limitations of the Research The scope of the research
Individuals who have internet connection at home or have internet on their mobile phone
Evaluation of only three-month effects
One of the limitations of the study is that it is based on self-report Research Variables
Independent variables
Sociodemographic characteristics of the participants
Dependent variables
Participants
Quality of Life Specific to Diabetes
Diabetes Self-Care Activities Scale score averages
Evaluation of Data The data will be evaluated in the SPSS 210 statistical program Frequency and percentage analyzes will be performed for categorical variables and mean and standard deviation analyzes will be performed for continuous variables
In comparing the research variables their suitability for normal distribution will be evaluated and then further statistical analyzes will be carried out The research will be conducted with a 95 confidence interval and a 005 margin of error
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