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

NCT05955755 | Completed

• 1 other identifier: 2023/ 08- 10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Child Development; Nursing Caries; Pain; Fear

Keywords

child; nurse; fear; pain; blood collection

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• Challenging Intravenous Intervention Score for Children

  1 day

• Child Fear Scale

  1 day

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

butterfly vacuum blood collection set OTHER

Blood collection from the children in the experimental group will be performed with a butterfly vacuum blood collection set.

experimental group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Fırat Univesity

Elâzığ, Turkey (Türkiye)

Location

Related Publications (10)

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  PMID: 12519290 BACKGROUND

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  PMID: 21806301 BACKGROUND

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  PMID: 10707264 BACKGROUND

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  PMID: 8432876 BACKGROUND

• Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.

  PMID: 18347490 BACKGROUND

• Inal S, Kelleci M. The Effect of External Thermomechanical Stimulation and Distraction on Reducing Pain Experienced by Children During Blood Drawing. Pediatr Emerg Care. 2020 Feb;36(2):66-69. doi: 10.1097/PEC.0000000000001264.

  PMID: 28885392 BACKGROUND

• Coventry LL, Jacob AM, Davies HT, Stoneman L, Keogh S, Jacob ER. Drawing blood from peripheral intravenous cannula compared with venepuncture: A systematic review and meta-analysis. J Adv Nurs. 2019 Nov;75(11):2313-2339. doi: 10.1111/jan.14078. Epub 2019 Jun 20.

  PMID: 31115075 BACKGROUND

• Ozalp Gerceker G, Ayar D, Ozdemir EZ, Bektas M. Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1151-1161. doi: 10.1111/jocn.15173. Epub 2020 Jan 22.

  PMID: 31889358 BACKGROUND

• Celikol S, Tural Buyuk E, Yildizlar O. Children's Pain, Fear, and Anxiety During Invasive Procedures. Nurs Sci Q. 2019 Jul;32(3):226-232. doi: 10.1177/0894318419845391.

  PMID: 31203776 BACKGROUND

• Sapci E, Bilsin Kocamaz E, Gungormus Z. Effects of applying external cold and vibration to children during vaccination on pain, fear and anxiety. Complement Ther Med. 2021 May;58:102688. doi: 10.1016/j.ctim.2021.102688. Epub 2021 Feb 26.

  PMID: 33640458 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Duygu Karaarslan

  Manisa Celal Bayar University

  STUDY CHAIR

• Atiye Karakul

  Tarsus University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 21, 2023
• Study Start: September 24, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)