The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear

November 23, 2023 updated by: Özlem Selime MERTER, Firat University

The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle Used in Blood Collection in Children on the Level of Pain and Fear: A Randomized Controlled Study

This study was planned to examine the effects of the butterfly vacuum blood collection set and standard vacutanier needle used during blood collection in children on the level of pain and fear. It is a randomized controlled trial.The study will be conducted in the pediatric blood collection unit with children between the ages of 7 and 12 who have undergone blood tests by a pediatrician.Data collection tools: "Descriptive Information Form", "Difficult Intravenous Intervention Score" for Children, "Numerical Pain Scale", "Child Fear Scale" will be used to collect data.The data will be uploaded to the computer and coded by the researchers, and the data will be evaluated in the SPSS package program. The sociodemographic data of the children participating in the study will be given as numbers and percentage distributions. Appropriate tests will be used by analyzing the data for normal distribution. The statistical significance level of the study was determined as p< 0.05. In addition, at the end of the research, the status of working with sufficient sample size will be tested with post-hoc power analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose of the study: This study was planned to examine the effects of the butterfly vacuum blood collection set and standard vacutanier needle used during blood collection in children on the level of pain and fear.

Type of Study: It is a randomized controlled study. Location and Characteristics of the Study: It will be conducted in the pediatric blood collection unit of Fırat University Hospital, with children aged 7-12 who are subjected to blood tests by a pediatrician.

Population-Sample: The population of the study will consist of children who applied for blood collection in the pediatric blood collection unit of Fırat University Hospital. A pilot study will be conducted to determine the number of samples. For the pilot study, 20 participants will be taken from each group and a total of 40 samples will be taken. As a result of the pilot study, power analysis will be performed and the number of samples will be determined. Randomization will be done to assign the participants to the groups. Grouping will be done using simple random sampling. Randomization will be provided using the Random Sequence Generator on the www.random.org website. Each participant who volunteers to participate in the study and meets the criteria will be given a number. Accordingly, which number will take place in which group will be determined in advance.

Data collection tools: "Descriptive Information Form", "Difficult Intravenous Intervention Score" for Children, "Numerical Pain Scale", "Child Fear Scale" will be used to collect data.

Data Collection: Data collection Children who accept to participate in the 1st stage study will be given the Difficult Intravenous Intervention Score for Children.

In the 2nd stage, an Introductory Information Form and Child Fear Scale will be used for children whose Difficulty Intravenous Intervention Score for Children is below 4.

In the 3rd phase, children who meet the research criteria will be randomized. In stage 4, blood collection from children will be performed by the same nurse (a volunteer nurse with 5 years of experience in pediatric phlebotomy). A butterfly vacuum blood collection set will be used for blood collection from the children in the experimental group, and a standard vacutanier needle will be used for the blood collection from the children in the control group.

In the 5th stage, children will be evaluated for pain and fear after bloodletting. This assessment will be made by the child, parent and nurse.

Evaluation of the data: The data will be uploaded to the computer and coded by the researchers, and the data will be evaluated in the SPSS package program. The sociodemographic data of the children participating in the study will be given as numbers and percentage distributions. Appropriate tests will be used by analyzing the data for normal distribution. The statistical significance level of the study was determined as p< 0.05. In addition, at the end of the research, the status of working with sufficient sample size will be tested with post-hoc power analysis.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Elazığ, Turkey
        • Fırat Univesity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Between the ages of 7-12

    • Do not have a chronic disease
    • Peripheral intravenous catheter (PIC) application by the same nurse (with at least 5 years of experience)
    • Able to express oneself verbally
    • No visual and auditory problems
    • Forced intravenous access score below 4

Exclusion Criteria:

  • Children treated with tropical anesthetic before the procedure

    • Children who have taken analgesics in the last 6 hours
    • Neurodevelopmentally delayed children
    • Children with chronic disease
    • Children with unsuccessful blood draw attempts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
A butterfly vacuum blood collection set will be used in the blood collection process from the children in the experimental group.
Other: butterfly vacuum blood collection set
Blood collection from the children in the experimental group will be performed with a butterfly vacuum blood collection set.
No Intervention: control group
A standard vacutanier needle will be used for blood collection from the children in the control group. Vacutanier needle is used routinely in the blood collection unit where the study will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Pain Scale
Time Frame: 1 day
This method, which is aimed at determining the severity of pain, aims to explain the patient's pain in numbers. Absence of pain (0) is evaluated as unbearable pain (10) on numerical scales.
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Challenging Intravenous Intervention Score for Children
Time Frame: 1 day
Visibility of the vein is scored as visible = 0, invisible = 2 points. The palpability of the vein is scored as palpable = 0, non-palpable = 2 points. Age status is scored as ≥ 36 months = 0, 12-35 months = 1, < 12 months = 3 points. In the variable of prematurity, children with a gestational age before 38 weeks are considered premature and scored as not premature = 0, premature = 3 points. The skin tone variable is evaluated as light and dark, scored as light = 0 and dark = 1. Skin tone cards of Dermablend cosmetics company were used for the skin tone variable (numbers 11 from light to dark skin, numbers 1-2-4-5 fair skin, numbers 3-6-7-8-9-10-11 dark skin). The score that can be obtained from this score varies between 0-11, if the score obtained from the score is four or more, the vascular access is considered difficult with a 50% probability of failure.
1 day
Child Fear Scale
Time Frame: 1 day
This Scale includes 5 different facial expressions. This scale is scored between 0 and 4, and it is stated to be a reliable and valid measurement tool in the evaluation of fear.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Investigators

  • Study Chair: Duygu Karaarslan, Manisa Celal Bayar University
  • Study Chair: Atiye Karakul, Tarsus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2023

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

November 20, 2023

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023/ 08- 10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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