THE EFFECT OF BUZZY® AND SHOTBLOKER® APPLICATION ON THE PAIN AND COMFORT LEVEL OF NEWBORNS DURING HEEL PRICK BLOOD SAMPLING IN NEWBORNS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Neonatal Infant Pain Scale (NIPS)
研究概览
简要总结
Aim: The study was designed to determine the effect of Buzzy® and Shotbloker® application on pain and comfort levels in newborns during heel pricking. Method:The study was a randomised controlled trial. The study sample consisted of 159 newborns (Buzzy: 53, Shotbloker: 53, control: 53) who had heel pricks between March 2025 and December 2025 at the Samandağ State Hospital Neonatal Care Unit. The data collection tools used will be the Newborn Information Form, the Newborn Pain Scale, the Newborn Comfort Behaviour Scale, and the Buzzy® and Shotbloker® devices. In the intervention group, the Buzzy® and Shotbloker® devices will be applied before and after heel pricking, while the control group will receive routine care. The infants' pain and comfort levels will be assessed by the nurse before and after the procedure.
详细描述
The study was designed as a randomised controlled trial to determine the effect of Buzzy® and Shotbloker® application on pain and comfort levels in newborns during heel prick blood sampling.
Materials and Methods Setting After obtaining ethical committee approval, the study will be conducted with babies admitted to the Neonatal Unit of Samandağ State Hospital between March and December 2025.
Sample According to the power analysis performed for the sample size, the power of the sample was calculated using the G*Power 3.1 programme in line with the literature. With a Type I error rate of 0.05 and a test power of 0.80 (α = 0.05, 1-β = 0.80), the minimum sample size (with 53 newborns in each group) was calculated to be 159.
Data Collection In the study, babies brought to the Neonatal Unit for heel prick blood sampling will first be evaluated according to the sampling criteria, and those who do not meet the criteria will be excluded from the study. The nurse researcher herself will collect the data, evaluate it using the NIPS pain scale and the Neonatal Comfort Behaviour Scale, collect the heel blood, and administer the Buzzy® and Shotbloker® applications. To ensure consistency in the application, heel blood will be collected from the left lateral foot of all infants included in the study by the same nurse.
Application Before the heel prick procedure, the room will be well lit and warm to ensure that the babies are comfortable. Babies in the Buzzy, Shotbloker, and control groups who meet the sample criteria will first be examined by a paediatrician, and if there are no contraindications for heel pricking, their parents will be informed about the study and their verbal and written consent will be obtained, after which the data collection form will be completed. The 'Baby Information Form' will be completed by the researcher before the heel pricking procedure. Immediately afterwards, the infant's physiological parameters (pulse, SpO2) will be measured, and the infant's pain and comfort will be assessed by the researcher using the NIPS Scale and YDKÖ. All infants participating in the study will be held in their mothers' arms during the heel prick procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The baby must be full-term (38-42 weeks),
- •No analgesic administration up to 8 hours prior to the procedure,
- •No pain prior to the procedure,
- •No chronic or metabolic disease,
- •Born at least 24 hours prior,
- •Being in the hospital during the study period
排除标准
- •The baby is not full-term,
- •Analgesic medication has been administered within 8 hours prior to the procedure,
- •The baby has a chronic or metabolic disease,
- •The baby requires oxygen support,
- •The baby cannot be fed orally,
- •The baby is not in the hospital on the dates the study will be conducted and the parents do not agree to participate in the study.
结局指标
主要结局
Neonatal Infant Pain Scale (NIPS)
时间窗: 1 day
The Neonatal Infant Pain Scale (NIPS) was developed by Lawrence and colleagues in 1993. Its validity and reliability in Turkish were established by Akdovan in 1999 (81). Reliability values were found to be 0.83, 0.83, and 0.86 before, during, and after the procedure, respectively. The neonatal infant pain scale assesses facial expressions (0; relaxed, 1; distressed), crying (0; no crying, 1; whimpering, 2; loud crying), breathing (0; relaxed, 1; variable-irregular), arm (0; relaxed-free, 1; flexion-extension), legs (0; relaxed-free, 1; flexion-extension), and sleep-wakefulness (0; sleeping-awake and calm, 1; restless). Pain is assessed based on the total score. After observation, the scale is scored from a maximum of 7 to a minimum of 0. According to the scale, a score of 7 indicates the highest level of pain, while a score of 0 indicates the lowest level of pain. If the NIPS score is between 0 and 2, the pain is considered to be absent or mild. If the pain score is between 3 and 4, i
Newborn Information Form
时间窗: 1 day
The information form has been prepared by reviewing the relevant literature and includes the baby's gestational age, gender, birth weight, birth length, mode of delivery, pre- and post-procedure physiological parameters (SPO2, pulse), NIPS Pain Score, and Newborn Comfort Behaviour Scale. The data collection form contains a total of 6 questions.
Newborn Comfort Behaviour Scale (NCBS)
时间窗: 1 day
The scale was first developed in 1992 by Ambuel and colleagues to assess distress in patients receiving mechanical ventilator support in a paediatric intensive care unit. Later, in 2009, Van Dijk and colleagues revised the scale and established the validity and reliability of the COMFORTneo scale for measuring behaviour in newborns without physiological parameters. The COMFORTneo scale (NCBS) consists of 6 parameters (alertness, calmness/agitation, The COMFORTneo scale (YKDÖ) is a Likert-type scale consisting of six parameters (alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, muscle tone). It is also a tool that provides nurses with numerical data to assess the comfort of newborns. The scale was revised in 2014 by Karaman et al. to establish its 'Turkish Validity and Reliability.' The lowest score on the scale is 6 and the highest score is 30, with high scores indicating that the baby is not comfortable. The Cronbach's alpha coefficient of t
次要结局
未报告次要终点
研究者
Duygu Sonmez Duzkaya
Principal Investigator
Tarsus University