Nestıng Technıque for Paın Management Durıng Heel Prick in Term Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Mean Total Score on the Neonatal Infant Pain Scale
研究概览
简要总结
Background: Determining the effectiveness of pain management strategies in newborns provide evidence to promote high-quality midwifery practices.
Purpose: The aim of the research is to evaluate the effect of the nesting technique on pain response during heel prick blood sampling in newborns.
Method: During the heel prick blood collection procedure at a university hospital, pain responses were evaluated in 29 full-term newborns who were held in a nest made of specially designed pillows for 3 minutes before, during, and after the procedure, and in 30 full-term newborns who underwent the routine procedure without being placed in a nest. Data were collected using the Baby Information Form, Observation Form, and the Neonatal Infant Pain Scale. A statistical software package was used for data analysis. As the data were normally distributed, the Independent t-test was used to compare group means, and Repeated Measures ANOVA was employed to assess differences over time.
详细描述
This study is a randomized controlled experimental trial designed to evaluate the effect of the nesting technique on behavioral and physiological outcomes - specifically pain scores, crying duration, respiratory rate, heart rate, and SpO₂ - measured at three time points: baseline (before the procedure), during the procedure, and during recovery (after the procedure).
Hypotheses H₀: The nesting technique has no significant effect on newborns' pain, crying duration, heart rate, oxygen saturation, or respiratory rate during heel prick blood sampling.
H₁: The nesting technique has significant effect on newborns' pain, crying duration, heart rate, oxygen saturation, or respiratory rate during heel prick blood sampling.
Sample Inclusion criteria for the study included term newborns undergoing routine heel prick blood sampling, with a birth weight between 2500 g and 4000 g, not receiving any medications, and whose parents provided consent for participation. The sample size was determined through a power analysis based on the Neonatal Infant Pain Scale (NIPS) score averages at the third measurement time point. The effect size, calculated as Cohen's d = 0.83, was derived from the difference between the intervention (2.06 ± 2.83) and control (4.44 ± 2.93) groups. For two independent groups, with a 95% confidence level (α = 0.05) and 80% statistical power (1-β = 0.80), it was determined that each group required at least 25 newborns. The study was completed with a total of 59 newborns, comprising 29 in the intervention group and 30 in the control group.
Intervention The study was conducted at a university hospital between May and August, 2024. Detailed information about the study was provided to the parents of eligible newborns, and written and verbal informed consent was obtained. Newborns were randomized by an independent researcher not involved in the intervention, using an online random list generator, namely, Random.org website, to ensure randomization. The randomization list was provided to the researchers performing the interventions in sealed envelopes to prevent bias during the study process. The study was conducted as a single-blind trial in which the researcher performing data analysis was blinded to group allocation; the clinical staff implementing the procedures could not be blinded due to the visible nature of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 1 Week（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term newborns undergoing routine heel prick blood
- •Weight between 2500 g and 4000 g,
- •Not receiving any medications, and Whose parents provided consent for participation.
排除标准
- •Newborns with any medical condition that could affect physiological or behavioral responses,
- •Infants who were clinically unstable or receiving medication
研究组 & 干预措施
Nesting technique
Newborns in the intervention group will undergo a nesting technique before heel prick blood sampling.
干预措施: Nesting technique (Procedure)
Control group
Newborns in the control group will be kept in their natural position on the bed during the heel prick blood test without any sedatives.
结局指标
主要结局
Mean Total Score on the Neonatal Infant Pain Scale
时间窗: Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period
The scale aims to determine newborn pain using 6 criteria: facial expression (0-1 points), crying (0-2 points), breathing pattern (0-1 points), arm movements (0-1 points), leg movements (0-1 points), and wakefulness level (0-1 points). Higher scores indicate a stronger pain response.
次要结局
- Mean Heart Rate(Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period)
- Mean Respiratory Rate(Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period)
- Mean Oxygen Saturation(Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period)
- Mean Crying Duration(Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period)
研究者
Meltem Aydın Beşen
Associate Professor
Mersin University