Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371599
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-04-14
Brief Title:
The Effect of Watching Cartoons and Playing Games as Distraction Method During Peripheral Intravenous Cannula Placement on Pain and Fear in Children Aged 6-9 Years
Sponsor:
Mersin University
Organization:
Mersin University
Study Overview
Official Title:
Comparison of the Effect of Watching Cartoons and Playing Games as Distraction Method During Peripheral Intravenous Cannula Placement on Pain and Fear in Children Aged 6-9 Years A Randomized Experimental Study
Status:
RECRUITING
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:
None
Brief Summary:
Active and passive distraction methods are frequently used in the nursing management of procedural pain in children There are no studies comparing the effects of watching cartoon passive and playing game active as distraction methods on pain and fear associated with peripheral intravenous cannula placement in children aged 6-9 years
This study aimed to compare the effects of playing game active distraction and watching cartoon passive distraction techniques on pain and fear during peripheral intravenous cannula placement in children aged 6-9 years
This study aimed to compare the effects of playing game active distraction and watching cartoon passive distraction techniques on pain and fear during peripheral intravenous cannula placement in children aged 6-9 years
Detailed Description:
Research Hypotheses
H1 There is a difference in the mean WB-FACES score during the procedure between the game group GG and the cartoon group CG
H2 There is a difference in the mean CFS score during the procedure between the GG and CG groups
Design and Settings This parallel-group randomized trial will be conducted at the invasive procedure room of the pediatrics department of a university hospital For this experimental research 64 children aged 6-9 years will be assigned to two groups Game GroupGG n 32 and Cartoon GroupCG n 32 using block randomization
Sample Size The trial sample was calculated based on the study findings of Ugucu G Uysal D A Polat O G Artuvan Z Kulcu D P Aksu D Temel G O 2022 Effects of cartoon watching and bubble-blowing during venipuncture on pain fear and anxiety in children aged 6-8 years a randomized experimental study Journal of Pediatric Nursing 65 e107-e114 A priori power analysis was performed based on the effect size d 0885 large effect of the difference in pain scores between the groups during the procedure Using GPower 3197 the minimum sample size was calculated as 56 children with 28 children per group for a two-tailed hypothesis an effect size of d 0885 an allocation ratio of n1n21 type I error of 005 and a power of 90 Considering that there may be drop-outs during the process the number of groups was increased by 20 The sample size of this study was determined as 64 children 32 children in each intervention group
Data Collection Tools Socio-Demographic Data Collection and Procedure Follow-up Form wilkk be used It includes age gender previous experience of hospitalization experience of procedural pain in last week analgesic administration at least six hours before the procedure size of peripheral IV needle area of IV blood sample parental presence during procedure and baseline data of pain anxiety and fear scores of children before procedure
The Wong-Bakers FACES Pain Rating Scale WB-FACES Developed by Wong and Baker in 1981 and revised in 1983 the instrument is used to assess physical pain in people who are communicative responsive and aged three years and older The scale consists of faces ranging from Face 0 no hurt to Face 10hurts worst
The Childrens Fear Scale CFS The instrument assessed the pain-associated fear in children Developed by McMurty et al 2011 the Turkish validity-reliability study of this visual scale was conducted by Özalp-Gerçeker et al 2018 and it is scored from 0 to 4 It ranges from a no fear neutral face 0 on the far left to a face showing extreme fear on the far right Higher scores mean a worse outcome
iPad mini In the both group for game and cartoon an iPad mini will be used that had a 79 inch diagonal LED-backlit Multi-Touch display 2048 x 1536 resolution with a density of 326 pixels per inch ppi with internet access
Interventions The invasive procedure room in the clinic which decorated with cartoon characters and ornaments on the walls will be used The intervention can be administered to only one child at a time in the room In routine practice the parental presence is supported during all invasive procedures performed on children However the nurses uniforms have a printpattern of cartoon characters in the routine practice The room will have the same characteristics for all children and their parents in terms of environmental conditions such as light temperature noise and seat Before the procedure childrens pain and fear will be assessed after providing developmentally appropriate information The parents will be also informed about how to support their children The same researchers will be performed the peripheral intravenous cannula placement R1 and observational pain and fear assessments R2 in all children R1 and R2 are nurses with more than five years of experience in pediatrics and degrees in scientific fields MScN PhD
Cartoon Group In the cartoon group the cartoons that the children liked to watch will be learned from the parents before the procedure First the physical comfort of the children will be ensured in the invasive procedure room The children will be asked which cartoon they want to watch before the procedure They will start to watch the cartoon 3 minutes before the procedure The children will be supported by their parents in holding the tablet The procedure and the cartoon watching intervention will be terminated simultaneously
Game Group In the game group the games that the children liked to play will be learned from the parents before the procedure First the physical comfort of the children will be ensured in the invasive procedure room The children will be asked which game they want to play before the procedure They will start to play the game 3 minutes before the procedure The children will be supported by their parents in holding the tablet The procedure and the game playing intervention will be terminated simultaneously
Ethical Considerations The study was granted approval by the clinical research ethics committee and written institutional permission by the hospital Parents will be informed about the procedure and that they could withdraw from the study at any time without explanation Written consent of parents and verbal consent of children before the study will be obtained
Statistical Methods The study data will be analyzed using the statistical program
H1 There is a difference in the mean WB-FACES score during the procedure between the game group GG and the cartoon group CG
H2 There is a difference in the mean CFS score during the procedure between the GG and CG groups
Design and Settings This parallel-group randomized trial will be conducted at the invasive procedure room of the pediatrics department of a university hospital For this experimental research 64 children aged 6-9 years will be assigned to two groups Game GroupGG n 32 and Cartoon GroupCG n 32 using block randomization
Sample Size The trial sample was calculated based on the study findings of Ugucu G Uysal D A Polat O G Artuvan Z Kulcu D P Aksu D Temel G O 2022 Effects of cartoon watching and bubble-blowing during venipuncture on pain fear and anxiety in children aged 6-8 years a randomized experimental study Journal of Pediatric Nursing 65 e107-e114 A priori power analysis was performed based on the effect size d 0885 large effect of the difference in pain scores between the groups during the procedure Using GPower 3197 the minimum sample size was calculated as 56 children with 28 children per group for a two-tailed hypothesis an effect size of d 0885 an allocation ratio of n1n21 type I error of 005 and a power of 90 Considering that there may be drop-outs during the process the number of groups was increased by 20 The sample size of this study was determined as 64 children 32 children in each intervention group
Data Collection Tools Socio-Demographic Data Collection and Procedure Follow-up Form wilkk be used It includes age gender previous experience of hospitalization experience of procedural pain in last week analgesic administration at least six hours before the procedure size of peripheral IV needle area of IV blood sample parental presence during procedure and baseline data of pain anxiety and fear scores of children before procedure
The Wong-Bakers FACES Pain Rating Scale WB-FACES Developed by Wong and Baker in 1981 and revised in 1983 the instrument is used to assess physical pain in people who are communicative responsive and aged three years and older The scale consists of faces ranging from Face 0 no hurt to Face 10hurts worst
The Childrens Fear Scale CFS The instrument assessed the pain-associated fear in children Developed by McMurty et al 2011 the Turkish validity-reliability study of this visual scale was conducted by Özalp-Gerçeker et al 2018 and it is scored from 0 to 4 It ranges from a no fear neutral face 0 on the far left to a face showing extreme fear on the far right Higher scores mean a worse outcome
iPad mini In the both group for game and cartoon an iPad mini will be used that had a 79 inch diagonal LED-backlit Multi-Touch display 2048 x 1536 resolution with a density of 326 pixels per inch ppi with internet access
Interventions The invasive procedure room in the clinic which decorated with cartoon characters and ornaments on the walls will be used The intervention can be administered to only one child at a time in the room In routine practice the parental presence is supported during all invasive procedures performed on children However the nurses uniforms have a printpattern of cartoon characters in the routine practice The room will have the same characteristics for all children and their parents in terms of environmental conditions such as light temperature noise and seat Before the procedure childrens pain and fear will be assessed after providing developmentally appropriate information The parents will be also informed about how to support their children The same researchers will be performed the peripheral intravenous cannula placement R1 and observational pain and fear assessments R2 in all children R1 and R2 are nurses with more than five years of experience in pediatrics and degrees in scientific fields MScN PhD
Cartoon Group In the cartoon group the cartoons that the children liked to watch will be learned from the parents before the procedure First the physical comfort of the children will be ensured in the invasive procedure room The children will be asked which cartoon they want to watch before the procedure They will start to watch the cartoon 3 minutes before the procedure The children will be supported by their parents in holding the tablet The procedure and the cartoon watching intervention will be terminated simultaneously
Game Group In the game group the games that the children liked to play will be learned from the parents before the procedure First the physical comfort of the children will be ensured in the invasive procedure room The children will be asked which game they want to play before the procedure They will start to play the game 3 minutes before the procedure The children will be supported by their parents in holding the tablet The procedure and the game playing intervention will be terminated simultaneously
Ethical Considerations The study was granted approval by the clinical research ethics committee and written institutional permission by the hospital Parents will be informed about the procedure and that they could withdraw from the study at any time without explanation Written consent of parents and verbal consent of children before the study will be obtained
Statistical Methods The study data will be analyzed using the statistical program
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