Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476418
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
The Effect of Distraction During Blood Collection on the Fear and Anxiety Levels of Children
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
The Effect of Distraction During Blood Collection on the Fear and Anxiety Levels of Children Aged Four to Six Years Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The project is a randomized controlled trial The population of the research will consist of children aged 4-6 years old who applied to Erzincan Mengücek Gazi Training and Research Hospital Pediatric Blood Collection Unit between June 2024 and June 2025 The sample of the research will consist of children who apply to the blood collection unit on the specified dates and meet the research criteria and volunteer to participate in the research Survey Form Child Fear Scale and Child Anxiety Scale-State will be used to collect data
Detailed Description:
Type of Research The research is of randomized controlled experimental type Place and Time of the Research The research will be carried out between June 2024 and June 2025 at the Pediatric Blood Collection Unit of Erzincan Mengücek Gazi Training and Research Hospital
Population and Sample of the Research The population of the research will consist of children between the ages of 4-6 who applied to Erzincan Mengücek Gazi Training and Research Hospital Pediatric Blood Collection Unit between June 2024 and June 2025 Research sample It will consist of children who apply to the blood collection unit on the specified dates and meet the research criteria and volunteer to participate in the research Prior power analysis was performed to determine the sample size in this study Cohens standard effect sizes were used as reference in the power analysis In this case for the t-test in independent groups in the study it was determined that 90 power could be achieved with a 95 confidence interval at a significance level of 005 if the research was conducted with a total of 84 participants in two groups with 42 participants in each group It was decided to collect data from a total of 90 children by including a 10 backup sample in this number in case of data loss
Data Collection Tools to be Used in the Research Survey Form Child Fear Scale and Child Anxiety Scale - Statefulness will be used in collecting research data The liquid motion timed fountain toy will be used as an interference tool
Intervention Tool to be Used in the Research Liquid Motion Timed Fountain Toy A liquid motion timed fountain toy will be used as an intervention tool in the research Guided by the cute bunny beanbag inside there is a fascinating sight of falling balls It is quite enjoyable to watch It is also made of a special material against breakage In this way it does not pose any risk to children Contains non-toxic materials It is safe for children
Before starting to collect the data of the intervention group and control group children the researcher will be in the pediatric blood collection unit for 1 day to examine the pediatric blood collection unit and conduct a preliminary application Children and their parents were given preliminary information about the research the purpose of the research why the research was conducted a liquid moving timed fountain toy will be used to relieve the childs fear and anxiety it is thought to be effective in preventing fear and anxiety etc and their written and verbal consent was obtained will be obtained through face-to-face meeting
Randomization In the study stratification and block randomization methods will be used to assign participants to the control and intervention groups It has been reported in the literature that factors affecting the fear and anxiety experienced by children during interventional procedures include variables such as age gender and fear of the interventional procedure In this study the variables age gender and fear of bloodletting will be used to stratify children Accordingly children will be stratified according to age 4-5 and 6 years gender girls and boys and fear of bloodletting afraid or not afraid and blocked randomization will be applied In the study 48 children will be included in each group by ensuring that the layers are repeated six times 2X2X2X6 The sealed envelope method will be used to assign stratified children to control and intervention groups without bias In order to prevent the child in one group from being affected by the procedure applied to the other group the data of each group will be collected on certain days of the week The data collection order of the groups will be determined by the sealed envelope method
blinding Since the researcher will be the person implementing the intervention in the study the researcher will be excluded from blinding For this reason participants in the control and intervention groups in the study will be blinded Children participating in the study will be excluded from blinding because they saw the method applied to them during blood collection The data of the research will be coded group A group B and recorded in the database The analysis of the research will be done by an independent statistician and statistical blinding will be done The research stages will be carried out according to the Consolidated Standards of Reporting Trials CONSORT guide Reporting of the research will be done according to the CONSORT Information Checklist
Control Group The researcher will fill out the questionnaire and scales 5 minutes before blood collection Only routine applications will be made The scales will be filled again 5 minutes after blood collection The toy will be gifted to the child after the procedure Filling out the forms will take approximately 5-10 minutes
Intervention Group The researcher will fill out the questionnaire and scales 5 minutes before blood collection The child will be allowed to play with the liquid moving timed fountain toy 3 minutes before blood collection During the process the child will continue to play with the toy The scales will be filled again 5 minutes after blood collection The toy will be gifted to the child after the procedure Filling out the forms will take approximately 5-10 minutes
Evaluation of Data Processing and statistical analysis of the collected data will be done with the analysis software called SPSS Statistical Package for the Social Sciences for Windows 200 In evaluating the data the statistical significance value will be accepted as 005 Type 1 error will be kept as 5 and evaluation will be made with a 95 confidence interval Cronbachs alpha value will be examined to determine the reliability of the measurement tools and analyzes will continue for measurements above 060 The normality distribution of the data will be determined by Kurtosis and Skewness coefficients 2 In the analysis of the data numbers percentages averages and standard deviations will be calculated In comparisons of paired groups t-test for independent samples will be used for measurements with normal distribution and Mann-Whitney U test will be used for measurements with non-normal distribution In intragroup comparisons of binary groups t-test for dependent samples will be used for measurements with normal distribution and Wilcoxon test will be used for measurements with non-normal distribution
Ethical Principles of Research In order to conduct the research ethical approval Number B302ATA00100272 Date 03052024 was received from Atatürk University Non-Interventional Clinical Research Ethics Committee Official permission will be obtained from the relevant institution The purpose of the study will be explained to children and their parents who meet the research group criteria their questions will be answered and their verbal and written consent will be obtained Parents and children will be informed that the data collected during the research will be processed confidentially and anonymously will not be used outside of the study in question and that they can leave the study at any time Since the research is based on the use of data obtained from humans and therefore the need to respect personal rights the relevant ethical principles of Informed Consent Volunteering and Protection of Confidentiality will be followed After the blood collection process is completed the children in the control group will be allowed to spend time with a liquid moving timed fountain toy and will be given as a gift thus trying to fulfill the Equality Principle
Population and Sample of the Research The population of the research will consist of children between the ages of 4-6 who applied to Erzincan Mengücek Gazi Training and Research Hospital Pediatric Blood Collection Unit between June 2024 and June 2025 Research sample It will consist of children who apply to the blood collection unit on the specified dates and meet the research criteria and volunteer to participate in the research Prior power analysis was performed to determine the sample size in this study Cohens standard effect sizes were used as reference in the power analysis In this case for the t-test in independent groups in the study it was determined that 90 power could be achieved with a 95 confidence interval at a significance level of 005 if the research was conducted with a total of 84 participants in two groups with 42 participants in each group It was decided to collect data from a total of 90 children by including a 10 backup sample in this number in case of data loss
Data Collection Tools to be Used in the Research Survey Form Child Fear Scale and Child Anxiety Scale - Statefulness will be used in collecting research data The liquid motion timed fountain toy will be used as an interference tool
Intervention Tool to be Used in the Research Liquid Motion Timed Fountain Toy A liquid motion timed fountain toy will be used as an intervention tool in the research Guided by the cute bunny beanbag inside there is a fascinating sight of falling balls It is quite enjoyable to watch It is also made of a special material against breakage In this way it does not pose any risk to children Contains non-toxic materials It is safe for children
Before starting to collect the data of the intervention group and control group children the researcher will be in the pediatric blood collection unit for 1 day to examine the pediatric blood collection unit and conduct a preliminary application Children and their parents were given preliminary information about the research the purpose of the research why the research was conducted a liquid moving timed fountain toy will be used to relieve the childs fear and anxiety it is thought to be effective in preventing fear and anxiety etc and their written and verbal consent was obtained will be obtained through face-to-face meeting
Randomization In the study stratification and block randomization methods will be used to assign participants to the control and intervention groups It has been reported in the literature that factors affecting the fear and anxiety experienced by children during interventional procedures include variables such as age gender and fear of the interventional procedure In this study the variables age gender and fear of bloodletting will be used to stratify children Accordingly children will be stratified according to age 4-5 and 6 years gender girls and boys and fear of bloodletting afraid or not afraid and blocked randomization will be applied In the study 48 children will be included in each group by ensuring that the layers are repeated six times 2X2X2X6 The sealed envelope method will be used to assign stratified children to control and intervention groups without bias In order to prevent the child in one group from being affected by the procedure applied to the other group the data of each group will be collected on certain days of the week The data collection order of the groups will be determined by the sealed envelope method
blinding Since the researcher will be the person implementing the intervention in the study the researcher will be excluded from blinding For this reason participants in the control and intervention groups in the study will be blinded Children participating in the study will be excluded from blinding because they saw the method applied to them during blood collection The data of the research will be coded group A group B and recorded in the database The analysis of the research will be done by an independent statistician and statistical blinding will be done The research stages will be carried out according to the Consolidated Standards of Reporting Trials CONSORT guide Reporting of the research will be done according to the CONSORT Information Checklist
Control Group The researcher will fill out the questionnaire and scales 5 minutes before blood collection Only routine applications will be made The scales will be filled again 5 minutes after blood collection The toy will be gifted to the child after the procedure Filling out the forms will take approximately 5-10 minutes
Intervention Group The researcher will fill out the questionnaire and scales 5 minutes before blood collection The child will be allowed to play with the liquid moving timed fountain toy 3 minutes before blood collection During the process the child will continue to play with the toy The scales will be filled again 5 minutes after blood collection The toy will be gifted to the child after the procedure Filling out the forms will take approximately 5-10 minutes
Evaluation of Data Processing and statistical analysis of the collected data will be done with the analysis software called SPSS Statistical Package for the Social Sciences for Windows 200 In evaluating the data the statistical significance value will be accepted as 005 Type 1 error will be kept as 5 and evaluation will be made with a 95 confidence interval Cronbachs alpha value will be examined to determine the reliability of the measurement tools and analyzes will continue for measurements above 060 The normality distribution of the data will be determined by Kurtosis and Skewness coefficients 2 In the analysis of the data numbers percentages averages and standard deviations will be calculated In comparisons of paired groups t-test for independent samples will be used for measurements with normal distribution and Mann-Whitney U test will be used for measurements with non-normal distribution In intragroup comparisons of binary groups t-test for dependent samples will be used for measurements with normal distribution and Wilcoxon test will be used for measurements with non-normal distribution
Ethical Principles of Research In order to conduct the research ethical approval Number B302ATA00100272 Date 03052024 was received from Atatürk University Non-Interventional Clinical Research Ethics Committee Official permission will be obtained from the relevant institution The purpose of the study will be explained to children and their parents who meet the research group criteria their questions will be answered and their verbal and written consent will be obtained Parents and children will be informed that the data collected during the research will be processed confidentially and anonymously will not be used outside of the study in question and that they can leave the study at any time Since the research is based on the use of data obtained from humans and therefore the need to respect personal rights the relevant ethical principles of Informed Consent Volunteering and Protection of Confidentiality will be followed After the blood collection process is completed the children in the control group will be allowed to spend time with a liquid moving timed fountain toy and will be given as a gift thus trying to fulfill the Equality Principle
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