Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339112
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-24
Brief Title:
The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety on Children
Sponsor:
Tarsus University
Organization:
Tarsus University
Study Overview
Official Title:
The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety of 4-6-year-old Children Who Are Administered Inhaler Medication
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on childrens fear and physiological parameters in 3-6 year old children who were administered inhaler medication The population of the study planned as a randomized controlled experimental study will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment According to the power analysis performed for the sample size the power of the sample was calculated with the GPower 31 program in line with the literature Durak 2019 Özsamuri 2020 While the amount of Type I error was 005 and the power of the test was 095 α 005 1-β 095 the minimal sample size was calculated as 105 children 35 children in each group Considering the possible losses from the sample for any reason during the study period it was planned to increase the number of samples by 10 and include 38 children in the study and control groups Child Information Form Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data
Detailed Description:
This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on childrens fear and physiological parameters in 3-6 year old children who were administered inhaler medication The population of the study planned as a randomized controlled experimental study will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment According to the power analysis performed for the sample size the power of the sample was calculated with the GPower 31 program in line with the literature While the amount of Type I error was 005 and the power of the test was 095 α 005 1-β 095 the minimal sample size was calculated as 105 children 35 children in each group Considering the possible losses from the sample for any reason during the study period it was planned to increase the number of samples by 10 and include 38 children in the study and control groups Child Information Form Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data
Data collection In the study children treated in pediatric emergency departments and administered inhaler medication will first be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study The nurse researcher is the one who collects the data evaluates it with the Fear and Anxiety Scale and evaluates the physiological parameters
Data analyses The data obtained in the study were analyzed using the Statistical Package for Social Sciences for Windows 250 program Descriptive statistical methods number percentage min-max values mean and standard deviation will be used when evaluating the data The suitability of the data used to normal distribution will be checked with kurtosis and skewness values In normally distributed data when comparing quantitative data an independent t-test will be used for the difference between two independent groups and when comparing more than two dependent groups analysis of variance will be applied in repeated measurements and in case of a difference Bonferroni will be used to find the group that makes the difference In comparing quantitative data with non-normally distributed data the Mann-Whitney U test will be applied for the difference between two independent groups and in comparing more than two dependent groups the Friedman test will be applied and in case of a difference the corrected Bonferroni will be used to find the group that makes the difference Chi-square analysis will be applied to test the relationship between categorical variables Cohens Kappa Test will be applied in interobserver agreement analysis
Data collection In the study children treated in pediatric emergency departments and administered inhaler medication will first be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study The nurse researcher is the one who collects the data evaluates it with the Fear and Anxiety Scale and evaluates the physiological parameters
Data analyses The data obtained in the study were analyzed using the Statistical Package for Social Sciences for Windows 250 program Descriptive statistical methods number percentage min-max values mean and standard deviation will be used when evaluating the data The suitability of the data used to normal distribution will be checked with kurtosis and skewness values In normally distributed data when comparing quantitative data an independent t-test will be used for the difference between two independent groups and when comparing more than two dependent groups analysis of variance will be applied in repeated measurements and in case of a difference Bonferroni will be used to find the group that makes the difference In comparing quantitative data with non-normally distributed data the Mann-Whitney U test will be applied for the difference between two independent groups and in comparing more than two dependent groups the Friedman test will be applied and in case of a difference the corrected Bonferroni will be used to find the group that makes the difference Chi-square analysis will be applied to test the relationship between categorical variables Cohens Kappa Test will be applied in interobserver agreement analysis
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