Effects of Vibration, Heel Warming and Shotblocker on Pain Levels During Heel Blood Collection: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- NIPS (Neonatal Infant Pain Scale)
研究概览
简要总结
This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Vibration, Heel Warming, and Shotblocker on pain levels during heel blood collection on healthy term newborn's.
详细描述
Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; Practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included.
This study is a prospective, randomized and controlled trial. In this study aim, the effect of Vibration, Heel Warming, and Shotblocker during heel blood collection on the pain levels in healthy term newborn's will be examined.
Sample of the study consisted of a total of 192 newborns who met the sample selection criteria and were selected via randomization method.
Newborns were divided into four groups; Vibration group (n=48), Heel Warming group (n=48), Shotblocker group (n=48), and Control group (n=48).
Data were collected using the Infant-family Information Form and NIPS - Neonatal Infant Pain Scale.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Days 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents who volunteered and gave consent to participate in the research
- •Full term neonates (38-42 weeks of gestation)
- •Underwent heel stick blood drawing for routine metabolic screening,
- •Aged 2 to 4 days
- •Passed the hearing screening
- •Birth weight between 2500-4400 grams
- •Parents who know how to read, write and speak Turkish.
排除标准
- •Parents with any mental problems
- •Infants with any chronic disease and congenital anomalies.
结局指标
主要结局
NIPS (Neonatal Infant Pain Scale)
时间窗: (average 5 minutes) during the heel blood collection procedures (1 min before the heel lance procedure (T-1 min), during the procedure (T+0 sec), and 2 min (T+2 min)
It was developed by Lawrence et al. in 1993 to evaluate interventional pain in newborns (Lawrence et al, 1993). Its Turkish adaptation was made by Akdovan and Yıldırım in 1999. NIPS is an assessment tool that focuses on six behavioral responses of newborns: facial expressions, crying, breathing, arm movements, leg movements, and arousal. A score between 0 and 7 is obtained from the scale, and as the score obtained from the scale increases, the pain of newborns also increases. In the Turkish adaptation study of the scale, the Cronbach's alpha value was calculated as 0.83 before the procedure, 0.83 during the procedure and 0.86 after the procedure.
次要结局
- Crying times(during the heel blood collection procedures (average 5 minutes))
- Processing time(during the heel blood collection procedures (average 5 minutes))
- The time to first calming(Procedure (The calming time was measured from the time of the first cry to the first calming time.) (average 5 minutes))
研究者
Selda Ateş Beşirik
Principal Investigator
Burdur Mehmet Akif Ersoy University