Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370117
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-04-04
Brief Title:
The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety
Sponsor:
Aydin Adnan Menderes University
Organization:
Aydin Adnan Menderes University
Study Overview
Official Title:
The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety
Status:
COMPLETED
Status Verified Date:
2024-04
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 research was conducted to evaluate the effects of three different non-pharmacological methods playing a music video buzzy application listening to a music video buzzy application on the pain and anxiety levels of children in the 4-12 age group during vascular access
H01 Playing music music video during the vascular access procedure has no effect on childrens pain and anxiety levels
H02 Applying buzzy during the vascular access procedure has no effect on childrens pain and anxiety levels
H03 Listening to a music video applying buzzy during the vascular access procedure has no effect on childrens pain and anxiety levels
H01 Playing music music video during the vascular access procedure has no effect on childrens pain and anxiety levels
H02 Applying buzzy during the vascular access procedure has no effect on childrens pain and anxiety levels
H03 Listening to a music video applying buzzy during the vascular access procedure has no effect on childrens pain and anxiety levels
Detailed Description:
Design It is a randomized controlled experimental study Methods This study was conducted between February and December 2023 with 126 children between the ages of 4 and 12 who were hospitalized in the pediatric ward of a public hospital in a province in eastern Turkey and had vascular access The sample consisted of four groups a music video listening group n31 a buzzy group n32 a music video listening buzzy group n31 and a control group n 32 Children were selected into groups by simple randomization method Data were collected 60 seconds before starting the vascular access procedure and as soon as the procedure was completed Introductory Information Form Child Fear and Anxiety Scale and Wong-Baker Facial Expression Rating Scale were used to collect data
The data was analyzed on SPSS Version 25 Chicago IL USA The Gaussian curve and Shapiro-Wilk test were used to assess whether or not the data were normally distributed Descriptive statistical tests arithmetic mean standard deviation number and percentage were also conducted The conformity of the measurement values to normal distribution was tested with Shapirow-wilk analysis Pearson chi-square test was applied to the dependency relationship of frequency measurement values One-factor ANOVA test was used to compare whether there was a statistically significant difference between the means of independent groups Kruskal Wallis H-Test was used to compare groups that did not show normal distribution Mann Whitney U test was used in further analysis to determine the difference between two independent groups Wilcoxon test was used to test the significance of the difference between the scores of two related measurements P values 005 were considered statistically significant
The data was analyzed on SPSS Version 25 Chicago IL USA The Gaussian curve and Shapiro-Wilk test were used to assess whether or not the data were normally distributed Descriptive statistical tests arithmetic mean standard deviation number and percentage were also conducted The conformity of the measurement values to normal distribution was tested with Shapirow-wilk analysis Pearson chi-square test was applied to the dependency relationship of frequency measurement values One-factor ANOVA test was used to compare whether there was a statistically significant difference between the means of independent groups Kruskal Wallis H-Test was used to compare groups that did not show normal distribution Mann Whitney U test was used in further analysis to determine the difference between two independent groups Wilcoxon test was used to test the significance of the difference between the scores of two related measurements P values 005 were considered statistically significant
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