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

NCT06089889 | Not Yet Recruiting

• 1 other identifier: VPP RCT 001
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Venous Puncture Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

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

Other: ice application

Group 2

EXPERIMENTAL

Group 2 will be control group, without ice application.

Other: control group

Interventions

ice application 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 1

control group 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.

Group 2

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children within age group of 5-7 years
• Children who were advised to undergo venous puncture in the pediatric ward

You may not qualify if:

• Chronically ill
• Mentally handicapped
• Already having local anesthesia at the venous puncture site

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: a staff nurse will be nominated for recording the child's pain intensity on video for objectively assessing the child's pain score. video recorder will be blinded of intervention. The staff nurse responsible for videotaping will be kept uninformed about the intervention and control group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Children will be allocated in two groups by randomization (lottery method). one group will be intervention group and other group would be control group

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 19, 2023
• Study Start: April 10, 2024
• Primary Completion: September 30, 2024
• Study Completion: November 15, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share