Comparison of the Effect of Ice Application and Distraction Technique on Venous Puncture Pain in Children

Study Overview
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Brief Summary
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the goal of this RCT is: to compare the effectiveness of two non pharmacological methods (ice application versus distraction technique) in reducing venous puncture pain among children aged 5 to 12 years old. An (RCT) will be conducted, involving 120 children, a non-probability convenience sampling will be used and children will randomly assign to two groups by lottery method. One group will receive ice application as an intervention, while other group will be exposed to distraction techniques (involving musical rhymes) as an intervention.

Detailed Description
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Children often undergo venous puncture in wards and emergency, a procedure that is both painful and distressing for both children and their parents. When pain is not effectively managed, it leads to fear, anxiety, uncooperative behavior, unsuccessful attempts, prolonged procedure duration, and overall dissatisfaction with the provided care. Various methods, both pharmacological and non-pharmacological, can help reduce pain during venous puncture, but most of these preparations are not feasible in urgent situations due to their time-consuming nature. The aim of this study is to compare the effectiveness of two non-pharmacological methods (ice application versus distraction technique by watching musical rhymes) in reducing venous puncture pain in children. It is hypothesized that there is a significant difference in the effectiveness of ice application and the utilization of a distraction technique (such as musical rhymes) in alleviating venous puncture pain among children. The rationale of this study is to find out a cost-effective method for reducing pain during IV puncture, and minimizing hospitalization costs for children and alleviating their fear of pain. An (RCT) will be conducted, involving 120 children, a non-probability convenience sampling will be used and children will randomly assign to two groups by lottery method. One group will receive ice application as an intervention, while other group will be exposed to distraction techniques (involving musical rhymes) as an intervention. The effectiveness of both approaches will be assessed through a comparative analysis of these two groups. The study will span duration of 3 months, starting after the synopsis receives approval. The target population for the study will be children aged 5 to 12 years. Pain will be assessed using the Wong-Baker Faces Pain Rating Scale. Data will be analyzed by using SPSS version 24. Descriptive statistics (frequency, percentage) will be used to describe the characteristics of study population. Chi square test will be used to examine the demographic information of the two groups. Independent t tests will be used to compare the mean of the both groups after intervention. The significance level of the tests will be considered at p value <0.05.The anticipated findings of this study lies in its comprehensive comparison of two methodologies to determine the most economically feasible non-pharmacological approach. By focusing on resource-limited hospitals in Pakistan, the study aims to swiftly identify a method that can be readily implemented, effectively cutting down hospitalization costs for children while also easing their pain-related issues. This research not only establishes a crucial benchmark in evidence collection but also paves the way for addressing pain-related challenges linked to venipuncture in pediatric patients, offering substantial benefits in the long run.

Official Title
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Comparison of the Effect of Ice Application and Distraction Technique on Venous Puncture Pain in Children

Conditions
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Venous Puncture Pain

Intervention / Treatment
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* Other: ice application
* Other: distraction technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children within age group of 5-12 years Children who were advised to undergo venous puncture in the pediatric ward Exclusion Criteria: Chronically ill Mentally handicapped Already having local anesthesia at the venous puncture site

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Children will be allocated in two groups by randomization (lottery method). Both groups receive different interventions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Group 1 will receive ice application as intervention 3 minutes before venous puncture. | Other: ice application<br>* Group 1 will undergo the first intervention, which involves the application of ice. Ice pack will be applied on the site of venipuncture prior to intravenous procedures for 3 minutes. The procedure of venous puncture will be carried out in accordance with established standard operating procedures (SOPs). pain will be assessed through Wong baker Faces Pain scale immediate after venous puncture procedure.<br>|
| Experimental: Group 2<br>Group 2 will receive distraction technique via musical rhymes for controlling venous puncture pain. | Other: distraction technique<br>* Group 2 will be administered the second intervention, which involves using musical rhymes as a distraction technique. A set of 20 musical rhymes will be created and stored. The distraction technique will involve the child watching musical rhymes 10 minutes before venipuncture, aiming to divert their attention away from venous puncture procedure. The venipuncture procedure will be carried out according to established standard operating procedures (SOPs), while the child will be engaged in seeing musical rhymes. pain will be assessed by Wong Baker Faces Pain Scale immediate after venous puncture procedure..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| venous puncture pain | pain will be measured by Wong baker faces pain scale after venipuncture.Donnie Wong and Connie Baker developed The Wong-Baker Faces Pain Rating Scale in 1983. They research that children had difficulty rating their pain with numbers yet responded well to facial expressions. Consequently, they developed the scale to help children better communicate their pain. The Wong-Baker Faces Pain Rating Scale is a tool that aids individuals in expressing their physical pain. It employs facial expressions, numerical values, and descriptive words, allowing for varied ways to convey pain intensity. This self-assessment method encompasses a range of six faces, from a smiling face denoting no hurt (0) to a tearful face representing hurts worst (10), enabling effective communication of pain severity. The Wong-Baker Faces Pain Scale has been extensively studied in literature, with its reliability and validity having already been established for children aged 3 to 18 years | pain will be assessed immediate after venous puncture procedure, and data collection will take 2 months |