Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541964
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
Two Different Distraction Methods for Reducing Procedural Pain in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Parent-Provide Distraction and Windmill Toy Blowing Methods on Pain During Venous Blood Collection in Children Aged 6-12 Years
Status:
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:
This research will be carried out in a randomized controlled experimental design in order to study the effect of parent-provide distraction and windmill toy blowing methods in reducing the pain caused by blood collection in children aged 6-12 who have applied to the childrens blood collection unit It will be taken by randomization so that there is no bias in the people who will be included in the study Randomization table httpswwwcalculatorsoupcom it was created using
After randomization the children in the parent-provide distraction group with parental participation will be asked riddles by the parent during the venous blood collection procedure The children in the windmill toy blowing group will blow a windmill toy during the venous blood collection process For the children in the control group no distraction will be made during venous blood collection As soon as the procedure is completed the pain score during the procedure and the pain score will be evaluated one minute after the procedure The evaluation will be made by the child parent and nurse who draws blood
After randomization the children in the parent-provide distraction group with parental participation will be asked riddles by the parent during the venous blood collection procedure The children in the windmill toy blowing group will blow a windmill toy during the venous blood collection process For the children in the control group no distraction will be made during venous blood collection As soon as the procedure is completed the pain score during the procedure and the pain score will be evaluated one minute after the procedure The evaluation will be made by the child parent and nurse who draws blood
Detailed Description:
Many different non-pharmacological methods are used to cope with adverse conditions such as pain caused by invasive procedures in children One of these non-pharmacological methods is distraction The American Pain Association recommends the use of distractions for pain control in children By focusing the childs attention in another direction the childs pain is controlled and reduced As distraction methods video games virtual reality glasses listening to music watching cartoons blowing balloons reading books blowing windmill toys parent-provide distraction are used
The aim of this study is to determine the effects of parent-provide distraction and windmill toy blowing in reducing pain during blood collection in children aged 6-12 years Power analysis was performed to determine the number of people to be included in the research The strength of the test was calculated using the GPower 31 program As a similar research in the relevant literature the effect size of the difference in pain was calculated as 1557 in the research conducted by Orhan 2020 In order to exceed the 95 value in determining the strength of the study 51 people including 17 people in groups with a significance level of 5 and an effect size of 1557 must be reached df32 t2036 In the research it was aimed to reach a total of 66 people including 22 people in groups taking into account the high strength of the test and the losses
The Information Form Wong Baker Faces Scale VAS will be used for data collection First of all those who meet the criteria for inclusion in the research and research the purpose of the research will explain to the parents who volunteered to participate and their children by explaining the purpose of the research information about the research will be provided by the executor Then about their participation in the study written and oral consent will be obtained from parents and oral consent will be obtained from children By obtaining information from the parent the information form will be filled out by the researcher before the blood collection procedure Blood collection procedure it will be performed by a single experienced nurse Parental participation in the group of diverting attention information about the riddles will be provided by the researcher By the research manager parents and children will be given information about the Wong Baker Faces Scale Research manager children in the windmill toy blowing group will be supervised by blowing the windmill No intervention will perform to reduce pain in the control group In all groups as soon as the procedure is completed and 1 minute after the procedure the childs pain will be evaluated with the Wong Baker Faces Scale The nurse and the parent will evaluate the childs pain with VAS During the evaluation pain assessments will be made in such a way that the child parent and nurse will not see each other in order not to be affected by each other It is estimated that the data collection process will take about 10-15 minutes
The aim of this study is to determine the effects of parent-provide distraction and windmill toy blowing in reducing pain during blood collection in children aged 6-12 years Power analysis was performed to determine the number of people to be included in the research The strength of the test was calculated using the GPower 31 program As a similar research in the relevant literature the effect size of the difference in pain was calculated as 1557 in the research conducted by Orhan 2020 In order to exceed the 95 value in determining the strength of the study 51 people including 17 people in groups with a significance level of 5 and an effect size of 1557 must be reached df32 t2036 In the research it was aimed to reach a total of 66 people including 22 people in groups taking into account the high strength of the test and the losses
The Information Form Wong Baker Faces Scale VAS will be used for data collection First of all those who meet the criteria for inclusion in the research and research the purpose of the research will explain to the parents who volunteered to participate and their children by explaining the purpose of the research information about the research will be provided by the executor Then about their participation in the study written and oral consent will be obtained from parents and oral consent will be obtained from children By obtaining information from the parent the information form will be filled out by the researcher before the blood collection procedure Blood collection procedure it will be performed by a single experienced nurse Parental participation in the group of diverting attention information about the riddles will be provided by the researcher By the research manager parents and children will be given information about the Wong Baker Faces Scale Research manager children in the windmill toy blowing group will be supervised by blowing the windmill No intervention will perform to reduce pain in the control group In all groups as soon as the procedure is completed and 1 minute after the procedure the childs pain will be evaluated with the Wong Baker Faces Scale The nurse and the parent will evaluate the childs pain with VAS During the evaluation pain assessments will be made in such a way that the child parent and nurse will not see each other in order not to be affected by each other It is estimated that the data collection process will take about 10-15 minutes
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