Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354608
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-03-12
Brief Title:
The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children
Sponsor:
University of Yalova
Organization:
University of Yalova
Study Overview
Official Title:
The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children A Randomised Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
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 study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear
Detailed Description:
IM injection is one of the medical procedures that causes pain and fear in children It has been reported that the effect of childrens previous pain and fearful experiences continues into adulthood and this may lead to the avoidance of subsequent medical procedures as a reaction to increased pain and fear For all these reasons pediatric nurses and other healthcare professionals should aim for successful pain control before and during painful procedures in children to prevent future adverse effects of painful medical procedures
Reducing the emotional impact of painful procedures in clinical practice through better pain control is very important for children Therefore all healthcare professionals especially nurses as the first person to welcome children into the hospital and the person who spends the most time with the child have important responsibilities in eliminating childrens fear of medical procedures It is very important for pediatric nurses to use nonpharmacological techniques to reduce pain in the IM injection procedure It is known that non-pharmacological pain control methods help the child cope with pain reduce pain and alleviate distress from invasive procedures The most commonly used of these approaches is the distraction technique also known as the distraction technique which is constructed with cognitive and behavioral processes These include relaxation techniques deep breathing listening to music singing and talking watching cartoons games vibration and cold applications and distraction cards As understood from the studies nonpharmacological approaches help the child cope with the pain experienced in invasive interventions and provide less pain
It is critical that all pediatric nurses and other healthcare workers who work with children learn about and practice pain-reduction techniques When the literature was reviewed it was discovered that there were no studies comparing audiobook and local vibration application to reduce pain and fear perceived during IM injections administered to pediatric patients whereas there were a limited number of studies evaluating the methods independently It is thought that there is a need for planning randomized controlled experimental nursing studies in this field This study is planned to determine the effect of the use of audio book and local vibration on the pain and fear experienced by children during intramuscular injection in children aged 4-6 years While the population of the study consisted of pediatric patients aged 4-6 years in the pediatric emergency unit between October 2023 and April 2024 the sample consisted of 120 children who met the sample selection criteria The research consists of 3 groups These groups will audio book group n40 local vibration group n40 and control group n40 In order for the groups to be distributed homogeneously the order produced by a computer program httpwwwrandomizationcom Balanced permutation was used Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list The control variable of the study is demographic characteristics of the children The dependent variables of the study are pain and fear score The data are collected using Introductory Information Form Wong-Baker FACES Pain Scale W-BPS Childrens Fear Scale CFS
Reducing the emotional impact of painful procedures in clinical practice through better pain control is very important for children Therefore all healthcare professionals especially nurses as the first person to welcome children into the hospital and the person who spends the most time with the child have important responsibilities in eliminating childrens fear of medical procedures It is very important for pediatric nurses to use nonpharmacological techniques to reduce pain in the IM injection procedure It is known that non-pharmacological pain control methods help the child cope with pain reduce pain and alleviate distress from invasive procedures The most commonly used of these approaches is the distraction technique also known as the distraction technique which is constructed with cognitive and behavioral processes These include relaxation techniques deep breathing listening to music singing and talking watching cartoons games vibration and cold applications and distraction cards As understood from the studies nonpharmacological approaches help the child cope with the pain experienced in invasive interventions and provide less pain
It is critical that all pediatric nurses and other healthcare workers who work with children learn about and practice pain-reduction techniques When the literature was reviewed it was discovered that there were no studies comparing audiobook and local vibration application to reduce pain and fear perceived during IM injections administered to pediatric patients whereas there were a limited number of studies evaluating the methods independently It is thought that there is a need for planning randomized controlled experimental nursing studies in this field This study is planned to determine the effect of the use of audio book and local vibration on the pain and fear experienced by children during intramuscular injection in children aged 4-6 years While the population of the study consisted of pediatric patients aged 4-6 years in the pediatric emergency unit between October 2023 and April 2024 the sample consisted of 120 children who met the sample selection criteria The research consists of 3 groups These groups will audio book group n40 local vibration group n40 and control group n40 In order for the groups to be distributed homogeneously the order produced by a computer program httpwwwrandomizationcom Balanced permutation was used Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list The control variable of the study is demographic characteristics of the children The dependent variables of the study are pain and fear score The data are collected using Introductory Information Form Wong-Baker FACES Pain Scale W-BPS Childrens Fear Scale CFS
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