Investigating the Impact of Ice Application on the Venous Puncture Pain in the Pediatric Population

NCT ID: NCT06089889

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2024-11-15

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

Conditions

Venous Puncture Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group 1

Group 1 will receive ice application as intervention 3 minutes before venous puncture.

Group Type: EXPERIMENTAL

ice application

Intervention Type: OTHER

• 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.

after taking consent from parents/guardians, the pain response of children will be video taped for the purpose of objectively assessing the pain. and data will be kept confidential.

Group 2

Group 2 will be control group, without ice application.

Group Type: EXPERIMENTAL

control group

Intervention Type: OTHER

• Group 2 will be control group, which involves no ice application
• The venipuncture procedure will be carried out according to established standard operating procedures (SOPs), pain will be assessed by Wong Baker Faces Pain Scale immediate after venous puncture procedure.

After obtaining consent from parents/guardians, the pain responses of children will be videotaped for the purpose of objectively assessing pain, and the data will be kept confidential.

Interventions

ice application

• 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.

after taking consent from parents/guardians, the pain response of children will be video taped for the purpose of objectively assessing the pain. and data will be kept confidential.

Intervention Type: OTHER

control group

• Group 2 will be control group, which involves no ice application
• The venipuncture procedure will be carried out according to established standard operating procedures (SOPs), pain will be assessed by Wong Baker Faces Pain Scale immediate after venous puncture procedure.

After obtaining consent from parents/guardians, the pain responses of children will be videotaped for the purpose of objectively assessing pain, and the data will be kept confidential.

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Health Sciences Lahore

OTHER

Sponsor Role: lead

Responsible Party

Sidra Sultan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

VPP RCT 001

Identifier Type: -

Identifier Source: org_study_id