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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Child Development, Nursing Caries, Pain, Fear

Intervention / Treatment
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* Other: butterfly vacuum blood collection set


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>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<br>* Blood collection from the children in the experimental group will be performed with a butterfly vacuum blood collection set.<br>|
| No Intervention: control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Pain Scale | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child, nurse, fear, pain, blood collection