Which Technique is Effective in Reducing the Pain of Peripheral Intravenous Catheterization in Pediatric Patients, Infra-Red Light or Buzzy®?

NCT05523518 | Unknown FDA Device

• 1 other identifier: 2022-10/22
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to examine the effect on the pain developing from peripheral intravenous catheterization (IV) in pediatric patients of an infra-red vein visualization device, AccuVein®, and Buzzy®, which can simultaneously produce vibration and cold. The research is planned as a prospective, randomized controlled study with an experimental design. Research data collection will be conducted at the Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University. The research sample will consist of children aged 7-12 years who attend the Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University for diagnosis or treatment, who have been ordered a peripheral intravenous catheter for intravenous treatment by a doctor, and whose participation is voluntarily accepted by themselves and their parents. It was calculated as a result of power analysis that the minimum sample size is 90 child patients, with 30 in each group, to reach an 80% power level, accepting a type I error level of 5%. Pediatric patients who fit the inclusion criteria of the study will be assigned to implementation and control groups with the use of a computer-generated randomization list, according to their age and gender. An Individual Data Collection Form and the Facial Expressions Pain Rating Scale will be used to collect data by face to face interview. Peripheral intravenous catheterization will be implemented on the veins of either the right or the left arm. The procedural steps of the standard vein entry protocol will be followed with all of the children in the implementation and control groups. In addition to the standard vein entry protocol, the following interventions will be conducted with the pediatric patients in the implementation groups. Peripheral intravenous catheterization with pediatric patients in the Buzzy® group: From one minute before the location of the catheter and until the end of the procedure, the researchers will place the Buzzy® device approximately 5cm above the area where the procedure will take place, with its wings under it. The gel in its wings will have been previously frozen solid in a refrigerator. In this way, vibration and cold will be applied, and immediately afterwards, vein entry will be performed. (For the children's safety, a piece of thin sterile gauze will be placed on the area in order to prevent direct contact between the ice wings and the skin.) Peripheral intravenous catheterization with pediatric patients in the AccuVein® group: In this group, the veins in the area where the entry is to be performed will be visualized with the AccuVein® infrared vein visualization device, and the standard catheter implementation will be performed in the vein which is decided on for entry. Peripheral intravenous catheterization with pediatric patients in the control group: With the pediatric patients in the control group, no intervention will be performed before or during the procedure, and routine IV catheterization will be carried out without the use of any device. Immediately after the procedure has been performed, an assistant researcher who is unaware of the catheterization method used will ask the children of all groups to assess their pain levels with the Facial Expressions Pain Rating Scale, and the scores indicated will be recorded on the data collection form. While the study is being conducted, the necessary measures will be taken to prevent the children included in the study from influencing each other, such as not allowing them to see the method applied to the other children.

Conditions

Pain Management

Keywords

pain control; nonpharmacological method; AccuVein®; Buzzy®; pediatric patients; peripheral intravenous catheterization

Outcome Measures

Primary Outcomes (1)

• Pain Scores on the Facial Expressions Pain Rating Scale

  pain severity in mm (Immediately after the procedure has been performed, an assistant researcher will ask the children of all groups to assess their pain severity with the Facial Expressions Pain Rating Scale, and the scores indicated will be recorded on the data collection form)

  4 months

Secondary Outcomes (4)

• weight

  4 months

• height

  4 months

• body mass index (BMI)

  4 months

• duration of catheterization

  4 months

Study Arms (3)

The Buzzy® group

EXPERIMENTAL

From one minute before the location of the catheter and until the end of the procedure, the researchers will place the Buzzy® device approximately 5cm above the area where the procedure will take place, with its wings under it. The gel in its wings will have been previously frozen solid in a refrigerator. In this way, vibration and cold will be applied, and immediately afterwards, vein entry will be performed. (For the children's safety, a piece of thin sterile gauze will be placed on the area in order to prevent direct contact between the ice wings and the skin.)

Device: The Buzzy®

the AccuVein® group

EXPERIMENTAL

In this group, the veins in the area where the entry is to be performed will be visualized with the AccuVein® infrared vein visualization device, and the standard catheter implementation will be performed in the vein which is decided on for entry.

Device: The AccuVein®

The control group

NO INTERVENTION

With the pediatric patients in the control group, no intervention will be performed before or during the procedure, and routine IV catheterization will be carried out without the use of any device.

Interventions

The Buzzy® DEVICE

From one minute before the location of the catheter and until the end of the procedure, the researchers will place the Buzzy® device approximately 5cm above the area where the procedure will take place, with its wings under it. The gel in its wings will have been previously frozen solid in a refrigerator. In this way, vibration and cold will be applied, and immediately afterwards, vein entry will be performed. (For the children's safety, a piece of thin sterile gauze will be placed on the area in order to prevent direct contact between the ice wings and the skin.)

The Buzzy® group

The AccuVein® DEVICE

In this group, the veins in the area where the entry is to be performed will be visualized with the AccuVein® infrared vein visualization device, and the standard catheter implementation will be performed in the vein which is decided on for entry.

the AccuVein® group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being aged 7-12 years
• Themselves and their parents participating voluntarily in the study
• Being able to correctly evaluate the Facial Expressions Pain Rating Scale
• Not having, in the area or extremity in which the implementation will be conducted, anything which could interfere with the intervention, such as symptoms or signs of infection, scar tissue, vein or nerve damage or loss of sensation
• Not having used an analgesic in the previous six hours
• Being able to speak and understand Turkish
• Having no visual, auditory or speaking problems
• Not having any condition which could affect the sensation of pain
• Having a peripheral intravenous catheter for the first time in the emergency service

You may not qualify if:

• Being mentally retarded
• Having a chronic or fatal illness
• Having any psychiatric diagnosis
• Being unconscious or being unable to communicate verbally
• Not having a vein opened for the first time
• Agitation in themselves or their family
• Themselves or their parents not wanting to participate in the study, or wishing to withdraw at some point during the study
• Any situation which could affect the sensation of pain
• Being younger than seven or older than 12 years

Sponsors & Collaborators

• Uludag University: lead

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seçil Salarcı, MSc

  Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University

  STUDY CHAIR

Central Study Contacts

Dilek Yılmaz, PhD

CONTACT

05073580330; dilekk@uludag.edu.tr

Hava Gökdere Çinar, PhD

CONTACT

+905054990090; havagokdere@uludag.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The intervention and measurements were carried out by the researcher
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bursa Uludag University, Department of Nursing

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: August 31, 2022
• Study Start: August 31, 2022
• Primary Completion: November 10, 2022
• Study Completion: November 20, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share