Clinical trial NCT06089889: Investigating the Impact of Ice Application on the Venous Puncture Pain in the Pediatric Population
Official title: Investigating the Impact of Ice Application on the Venous Puncture Pain in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Venous Puncture Pain
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 114
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children will be allocated in two groups by randomization (lottery method). one group will be intervention group and other group would be control group
Primary purpose: PREVENTION

Brief summary: the goal of this RCT is: "To evaluate the effectiveness of a non-pharmacological method (ice application) in reducing venous puncture pain among children aged 5 to 7 years.".

An (RCT) will be conducted, involving 114 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 control group, having no ice application.

Detailed description: Children often undergo venous punctures in wards and emergency rooms, a procedure that is both painful and distressing for both children and their parents. When pain is not effectively managed, it can lead to fear, anxiety, uncooperative behavior, unsuccessful attempts, prolonged procedure duration, and overall dissatisfaction with the care provided. 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 evaluate the effectiveness of a non-pharmacological method (ice application) in reducing venous puncture pain in children. It is hypothesized that there is a significant difference in the pain intensity/score among children in the intervention group (ice application) and the control group (without ice application).

The rationale of this study is to find a cost-effective method for reducing pain during IV puncture, minimizing hospitalization costs for children, and alleviating their fear of pain. A randomized controlled trial (RCT) will be conducted, involving 114 children. Non-probability convenience sampling will be used, and children will be randomly assigned to two groups using the lottery method. One group will receive ice application as an intervention, while the other group will serve as the control group. The effectiveness of this approach will be assessed through a comparative analysis of these two groups. The study will span a duration of 3 months, starting after the synopsis receives approval. The target population for the study will be children aged 5 to 7 years. Pain will be assessed using the Wong-Baker Faces Pain Rating Scale. Data will be analyzed using SPSS version 24. Descriptive statistics (frequency, percentage) will be used to describe the characteristics of the study population. The Chi-square test will be used to examine the demographic information of the two groups. Independent t-tests will be used to compare the means of both groups after intervention. The significance level of the tests will be considered at a p-value \< 0.05. The anticipated findings of this study lie in its comprehensive analysis of this methodology 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 addressing 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

Eligibility criteria: Inclusion Criteria:

* Children within age group of 5-7 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

Primary outcomes:
measure: venous puncture pain
timeFrame: pain will be assessed immediate after venous puncture procedure, and data collection will take 2 months
Secondary outcomes:
Other outcomes:
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