Clinical trial NCT05955755: The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Nursing Caries
Pain
Fear
Keywords: child
nurse
fear
pain
blood collection
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numerical Pain Scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
measure: Challenging Intravenous Intervention Score for Children
timeFrame: 1 day
measure: Child Fear Scale
timeFrame: 1 day
Locations:
city: Elazığ
country: Turkey
facility: Fırat Univesity
Study officials:
affiliation: Manisa Celal Bayar University
name: Duygu Karaarslan
role: STUDY_CHAIR
affiliation: Tarsus University
name: Atiye Karakul
role: STUDY_CHAIR
References:
citation: McKinley S, Coote K, Stein-Parbury J. Development and testing of a Faces Scale for the assessment of anxiety in critically ill patients. J Adv Nurs. 2003 Jan;41(1):73-9. doi: 10.1046/j.1365-2648.2003.02508.x.
citation: McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
citation: O'Conner-Von S. Preparing children for surgery--an integrative research review. AORN J. 2000 Feb;71(2):334-43. doi: 10.1016/s0001-2092(06)62113-3.
citation: Thompson RH, Vernon DT. Research on children's behavior after hospitalization: a review and synthesis. J Dev Behav Pediatr. 1993 Feb;14(1):28-35.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.