Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655103
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-19
Brief Title:
The Effect of the Educational Movie Shown to Pediatric Patients Receiving Intrathecal Chemotherapy Treatment on Pre-Procedure Fear and Post-Procedure Pain in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of the Educational Movie Shown to Pediatric Patients Receiving Intrathecal Chemotherapy Treatment on Pre-Procedure Fear and Post-Procedure Pain in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study which is planned to be conducted in a randomized controlled experimental design nonpharmacological methods educational film shown with virtual reality goggles and cartoon shown with virtual reality goggles applied to children aged 5-10 years who will receive intrathecal chemotherapy treatment before intrathecal chemotherapy treatment were evaluated It is aimed to determine the effect on pre-procedure fear and post-procedure pain
The study is planned to be conducted between November 2024 and November 2025 The population of the study will consist of children between the ages of 5-10 years who receive inpatient treatment in the Pediatric Hematology Clinic of Izmir Ege University Hospital Health Practice and Research Center Random sampling method and stratified randomization method will be used for sample selection In the calculation of the sample size of the study using G-Power 3197 program type 1 error α 005 power 1- β 99 and Cohens effect size δ 05 the sample size to represent the main mass was determined as 90 children for this study However when the dropout rate is set as 10 for data loss that may occur in the study the minimum number to be reached for the study is targeted as 99 intervention group 1 n33 intervention group 2 n33 control group n33
Research data will be collected after project acceptance In all three groups children and their parents will be informed before the study and their written and verbal consent will be obtained Data will be collected by using the Introductory Information Form Intervention Follow-up Form and Child Fear Scale CFS Wong Baker FACES WB-FACES Pain Rating Scale and Visual Analog Scale VAS prepared by the researchers with the feedback of nurses parents and children
Statistical analyses will be performed using IBM SPSS Statistics 260 IBM SPSS Statistics for Windows package program The significance level will be set as 005 in all analyzes In the study numerical data will be calculated using mean standard deviation median minimum maximum values and categorical data will be calculated using frequency and ratio values
With the nonparametric Brunner-Langer model the before-after change group effect before-after effect and interaction effect of fear scores in the educational film cartoon and control groups will be examined using R 331 software R software version 331 package nparLD R Foundation for Statistical Computing Vienna Austria httpr-projectorg In order to visually examine this change the relative effects graph since the nonparametric method is used will be utilized
When the Brunner-Langer model shows that the before-after change in the groups is not similar interaction 005 the before-after comparison in each group will be made separately with the Wilcoxon sign test and the differences between the groups will be compared with the Kruskal-Wallis test by taking the after-before difference After Kruskal-Wallis pairwise comparisons will be made with the Dunn test and then Bonferroni correction will be used for p values The agreement between the measurements of Nurses Parents and Children will be evaluated by Intraclass Correlation ICC analysis
The study is planned to be conducted between November 2024 and November 2025 The population of the study will consist of children between the ages of 5-10 years who receive inpatient treatment in the Pediatric Hematology Clinic of Izmir Ege University Hospital Health Practice and Research Center Random sampling method and stratified randomization method will be used for sample selection In the calculation of the sample size of the study using G-Power 3197 program type 1 error α 005 power 1- β 99 and Cohens effect size δ 05 the sample size to represent the main mass was determined as 90 children for this study However when the dropout rate is set as 10 for data loss that may occur in the study the minimum number to be reached for the study is targeted as 99 intervention group 1 n33 intervention group 2 n33 control group n33
Research data will be collected after project acceptance In all three groups children and their parents will be informed before the study and their written and verbal consent will be obtained Data will be collected by using the Introductory Information Form Intervention Follow-up Form and Child Fear Scale CFS Wong Baker FACES WB-FACES Pain Rating Scale and Visual Analog Scale VAS prepared by the researchers with the feedback of nurses parents and children
Statistical analyses will be performed using IBM SPSS Statistics 260 IBM SPSS Statistics for Windows package program The significance level will be set as 005 in all analyzes In the study numerical data will be calculated using mean standard deviation median minimum maximum values and categorical data will be calculated using frequency and ratio values
With the nonparametric Brunner-Langer model the before-after change group effect before-after effect and interaction effect of fear scores in the educational film cartoon and control groups will be examined using R 331 software R software version 331 package nparLD R Foundation for Statistical Computing Vienna Austria httpr-projectorg In order to visually examine this change the relative effects graph since the nonparametric method is used will be utilized
When the Brunner-Langer model shows that the before-after change in the groups is not similar interaction 005 the before-after comparison in each group will be made separately with the Wilcoxon sign test and the differences between the groups will be compared with the Kruskal-Wallis test by taking the after-before difference After Kruskal-Wallis pairwise comparisons will be made with the Dunn test and then Bonferroni correction will be used for p values The agreement between the measurements of Nurses Parents and Children will be evaluated by Intraclass Correlation ICC analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None