Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371612
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2024-04-14
Brief Title:
Effects of Squeezing Ball and Using Adhesive Remover on Pain and Fear in Children Aged 6-9 Years During the Removal of Peripheral Intravenous Cannula
Sponsor:
Mersin University
Organization:
Mersin University
Study Overview
Official Title:
Comparison of the Effects of Ball Squeezing and Adhesive Remover Use on Pain and Fear in Children Aged 6-9 Years During the Removal of Peripheral Intravenous Cannula A Randomised Experimental Study
Status:
COMPLETED
Status Verified Date:
2024-09
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:
Pediatric nurses have a key role in reducing pain related to interventions during the hospitalisation process In this context according to the type of invasive intervention the nurse determines the appropriate non-pharmacological methods for the effective management of pain taking into account the child39s individuality developmental stage and clinical presentation For children during the hospitalisation process the removal of a peripheral venous line is a painful and stressful experience as is the insertion of a peripheral venous line Children experience acute pain during the removal of hypoallergenic adhesives used for fixation of the peripheral venous line The practice guideline recommends the use of alcohol-free silicone-based aerosol sprays for the removal of medical adhesive fixation materials NICU Brain Sensitive Care Committee 2015
In this study it was aimed to examine the effect of ball squeezing active distraction as a distraction method and the use of alcohol-free silicone-based aerosol adhesive remover spray on pain and fear in children aged 6-9 years during peripheral intravenous cannula removal
In this study it was aimed to examine the effect of ball squeezing active distraction as a distraction method and the use of alcohol-free silicone-based aerosol adhesive remover spray on pain and fear in children aged 6-9 years during peripheral intravenous cannula removal
Detailed Description:
Research Hypotheses
H1 There is a difference in the mean WB-FACES score during the procedure between the groups
H2 There is a difference in the mean CFS score during the procedure between the 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 90 children aged 6-9 years will be assigned to three groups Standard Care Group SCG n 30 Adhesive Remover Spray Group ARSG n30 and Ball Squeezing Adhesive Remover Spray GroupBSG n 30 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 amp 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 74 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 10 The sample size of this study was determined as 90 children 30 children in each intervention group
Data Collection Tools It is decided to use the Child Information Form Wong-Bakers FACES Pain Rating Scale and Child Fear Scale to collect the data It includes 34age 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 procedure34
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 34Face 0 no hurt34 to 34Face 10hurts worst34
The Children39s 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
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 nurses39 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 children39s 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 removal of peripheral intravenous cannula 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
Standard Care Group First the physical comfort of the children will be ensured in the invasive procedure room In standard care practice the parental presence is supported during all invasive procedures performed on children Two minutes before the removal of the peripheral intravenous cannula cotton balls soaked in antiseptic solution and squeezed will be gently applied to the fixation area
Adhesive Remover Spray Group First the physical comfort of the children will be ensured in the invasive procedure room Two minutes prior to the removal of the peripheral intravenous cannula an alcohol-free silicone-based aresol spray for medical use will be gently applied to the fixation site The children will be supported by their parents
Ball Squeezing Adhesive Remover Spray Group First the physical comfort of the children will be ensured in the invasive procedure room Two minutes prior to the removal of the peripheral intravenous cannula an alcohol-free silicone-based aresol spray for medical use will be gently applied to the fixation site At the same time children will start squeezing the stress ball The ball squeezing intervention will be terminated when the removal of the peripheral intravenous cannula is completed The children will be supported by their parents
Ethical Considerations The study was granted approval by the ethics committee and written institutional permission by the hospital Parents and children 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 statistical significance level was determined as 005 Kolmogrow-Smirnov test will be used in the normality analysis of dependent variables Chi-square and comparison of means tests will be used to determine the similarity of the groups Appropriate parametric or non-parametric tests will be used according to the normality of the distribution in the comparison of means between groups and within groups In case of differences in the averages between groups the effect size appropriate to the test family will be used
H1 There is a difference in the mean WB-FACES score during the procedure between the groups
H2 There is a difference in the mean CFS score during the procedure between the 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 90 children aged 6-9 years will be assigned to three groups Standard Care Group SCG n 30 Adhesive Remover Spray Group ARSG n30 and Ball Squeezing Adhesive Remover Spray GroupBSG n 30 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 amp 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 74 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 10 The sample size of this study was determined as 90 children 30 children in each intervention group
Data Collection Tools It is decided to use the Child Information Form Wong-Bakers FACES Pain Rating Scale and Child Fear Scale to collect the data It includes 34age 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 procedure34
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 34Face 0 no hurt34 to 34Face 10hurts worst34
The Children39s 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
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 nurses39 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 children39s 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 removal of peripheral intravenous cannula 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
Standard Care Group First the physical comfort of the children will be ensured in the invasive procedure room In standard care practice the parental presence is supported during all invasive procedures performed on children Two minutes before the removal of the peripheral intravenous cannula cotton balls soaked in antiseptic solution and squeezed will be gently applied to the fixation area
Adhesive Remover Spray Group First the physical comfort of the children will be ensured in the invasive procedure room Two minutes prior to the removal of the peripheral intravenous cannula an alcohol-free silicone-based aresol spray for medical use will be gently applied to the fixation site The children will be supported by their parents
Ball Squeezing Adhesive Remover Spray Group First the physical comfort of the children will be ensured in the invasive procedure room Two minutes prior to the removal of the peripheral intravenous cannula an alcohol-free silicone-based aresol spray for medical use will be gently applied to the fixation site At the same time children will start squeezing the stress ball The ball squeezing intervention will be terminated when the removal of the peripheral intravenous cannula is completed The children will be supported by their parents
Ethical Considerations The study was granted approval by the ethics committee and written institutional permission by the hospital Parents and children 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 statistical significance level was determined as 005 Kolmogrow-Smirnov test will be used in the normality analysis of dependent variables Chi-square and comparison of means tests will be used to determine the similarity of the groups Appropriate parametric or non-parametric tests will be used according to the normality of the distribution in the comparison of means between groups and within groups In case of differences in the averages between groups the effect size appropriate to the test family will be used
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