Experimental Randomized Study: The Effect of White Noise and Facilitated Tucking Applications During Heel-Stick Sampling on Pain in Term Babies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pain severity (scores)
研究概览
简要总结
A randomised clinical trial in a single centre. This study was performed to compare the effect of white noise, facilitated tucking, and their concerted application during heel-stick sampling on pain in term babies.
The study was conducted on 90 babies. Using stratification and blocking method, 30 babies were included in the white noise group (1st Group), 30 in facilitated tucking group (2nd Group), and 30 in white noise + facilitated tucking group (3rd Group). Pain scores of the babies in all groups before, during, and after the procedure were evaluated by two nurses independent from each other using Neonatal Infant Pain Scale (NIPS).
详细描述
Aims and objectives: This study was performed to compare the effect of white noise, facilitated tucking, and their concerted application during heel-stick sampling on pain in term babies.
Design: A randomised clinical trial in a single centre. Methods: The study sample size was determined by the free-software G* Power. Based on the power analysis performed prior to the study in order to determine the number of babies to be included in the sample group (with β=0.14087 and α=0.05 risk, Power=0.85913), according to the study by Karakoc and Turker (2014), it was found that 27 neonates should be included in each group. The study was conducted on 90 babies, between July 1, 2017 - August 9, 2017. Using stratification and blocking method, 30 babies were included in the white noise group (1st Group), 30 in facilitated tucking group (2nd Group), and 30 in white noise + facilitated tucking group (3rd Group). Pain scores of the babies in all groups before, during, and after the procedure were evaluated by two nurses independent from each other using Neonatal Infant Pain Scale (NIPS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Pain scores of the babies before, during and after the procedure were evaluated independently by the researcher and the nurse other than the one who performed heel-stick sampling. Cohen's Kappa test was performed in the evaluation of the NIPS pain scores to test the concordance of the scores given to the same situation by 1 nurse and 1 researcher and it was found that the concordance of the scores given by 2 nurses was perfectly concordant (almost completely concordant) (Kappa Coefficient=0.953, p=0.027).
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being term baby
- •Being with mother
- •Being a healthy baby
- •Being able fed orally
- •Being fed at least half an hour before the procedure
- •Being able to draw blood at the first try (since the pain level will change on the second try)
- •Agreed to participate in the study and gave verbal consent were included in the study.
排除标准
- •Having received analgesics and/or sedatives within the last 24 hours
- •Having any complications that prevent pain evaluation (e.g. intracranial hemorrhage, neuromotor growth retardation, etc.)
- •Having undergone any painful procedures within the last hour (e.g. blood drawing, aspiration, ophthalmologic examination, etc.)
- •Prior history of surgery
- •Being connected to mechanical ventilator
研究组 & 干预措施
White Noise
The "white noise" used in our study is a fragment called "Bebeğiniz ağlamasın-2" from "Kolik" album of Buzuki Orhan Osman, which was used in similar studies (Balci, 2006; Karakoc & Turker, 2014; Kucukoglu et al., 2016).Since the white noise is a continuously monotonous sound, which is in the form of a hum, it resembles the sounds in mother's womb (Balci, 2006).
干预措施: White Noise (Other)
Facilitated Tucking
Facilitated tucking is the procedure of holding the baby's arms and legs in a flexed position close to the midline of the torso, and the baby is able to move his/her extremities during this procedure (Caglayan, 2011).
干预措施: Facilitated Tucking (Other)
White Noise+Facilitated Tucking
Both applications performed together.
干预措施: White Noise+Facilitated Tucking (Other)
结局指标
主要结局
Pain severity (scores)
时间窗: 2 MONTHS
Pain was evaluated separately by NIPS by two individuals, one investigator and one nursing nurse. The scores given by the investigator and the nurse were used to determine pain scores before, during and after heel blood collection. Pain severity was expressed as mean score NIPS.Neonatal Infant Pain Scale (NIPS) was used in the evaluation of the pain of the neonates. This scale was developed by Lawrence et al. (1993). The validity and reliability of the Turkish version of the test were assessed by Akdovan (1999). There are six variables in the scale. These are baby's breathing pattern, wakefulness, crying, facial movements and arm and leg movements. These variables are scored between 0-1. Only crying is scored between 0-2. The total score is between 0-7. The resulting score is directly proportional to the severity of the pain. That is, as the score increases, the severity of the pain increases (Akdovan, 1999). The study was completed with 90 infants.
次要结局
- Crying time(2 MONTHS)
研究者
Aylin PEKYİGİT
Research Assistant
Çankırı Karatekin University