The Effect of the Shotblocker and Breastfeeding on Pain and Comfort Level During Heel Lance Procedure in Newborns: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Neonatal Infant Pain Scale (NIPS)
研究概览
简要总结
Shotblocker and breastfeeding are an attempt to reduce pain during invasive procedures in newborns. This study was planned to evaluate the effect of non-pharmacological interventions on the pain and comfort level of newborns, whose heel blood will be taken in the 1st Level Neonatal Intensive Care Unit.
详细描述
Hypotheses H1: Newborns who undergo breastfeeding attempt during heel lance procedure feel less pain and have a higher comfort level.
H2: Newborns who undergo breastfeeding attempt and are applied shotblocker during heel lance procedure feel less pain and have a higher comfort level.
H3: Newborns who undergo shotblocker intervention during heel lance procedure feel less pain and have a higher comfort level.
H4: There are a difference between the comfort levels, HR and PO2 of newborns in terms of group, group-time and time according to the intervention applied.
Data collection process Mothers of newborns whose heel blood will be taken will be informed about the research. Consent will be obtained from the mother regarding the video recording during the heel lance precedure. After informed consent is obtained, it will be determined which group the newborn belongs to by stratified randomization.
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)
盲法说明
attempt will be videotaped, outcome evaluators will be blind
入排标准
- 年龄范围
- 1 Day 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth week is between 34-42 weeks,
- •Postnatal in the first 10 days
- •Birth weight is between 2500-4000 grams,
- •Stable general condition,
- •Being with her mother and literate,
- •Breastfeeding,
- •Newborns of mothers who agreed to participate in the study
排除标准
- •In need of oxygen support,
- •Unsuccessful heel lance attempt, patients whose heel lance cannot be taken in 30 sec.(in groups with shotblocker)
- •Needing parenteral nutrition,
- •Receiving analgesic treatment,
- •Having physical, metabolic and genetic diseases,
- •Having a mental or mental health problem in the mother
- •Non-breastfed newborns
- •Newborns hospitalized in the 3rd and 4th level neonatal intensive care unit
研究组 & 干预措施
Breastfeeding intervention
The baby will be placed on the mother's lap 2 minutes before the procedure. 2 minutes before the heel lance, the mother starts to breastfeed her baby and continues to breastfeed throughout the procedure and until the last touch to baby. If necessary, the researcher may verbally warn the mother in a calm tone to continue breastfeeding throughout the procedure. During the resting period (last 2 minutes) after the blood draw is completed, the baby stays on the mother's lap.
干预措施: breastfeeding (Behavioral)
Shotblocker intervention
2 minutes before the procedure, the baby will be placed on the mother's lap. ShotBlocker is a small plastic tool that is blunt, short, has many points in contact with the skin, does not contain drugs, is in the shape of a horseshoe, invasive interventions can be applied through the space in the middle. It is positioned on the skin before the invasive procedure. The investigator should make sure that the contact points touch the skin. Shotblocker is pressed firmly for 20 seconds before the intervention, it is pulled from the area and the heel is pierced with the lancet. After Shotblocker is applied to the skin, invasive intervention should be performed within 30 seconds and the protocol should be followed. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.
干预措施: shotblocker (Device)
Breastfeeding and Shotblocker intervention
The baby will be placed on the mother's lap 2 minutes before the procedure. 2 minutes before the heel lance, the mother starts to breastfeed her baby and continues to breastfeed throughout the procedure and until the last touch to baby. The investigator should make sure that the contact points touch the skin. Shotblocker is pressed firmly for 20 seconds before the intervention, it is pulled from the area and the heel is pierced with the lancet. After Shotblocker is applied to the skin, invasive intervention should be performed within 30 seconds and the protocol should be followed. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.
干预措施: Breastfeeding and Shotblocker (Combination Product)
Control group/ Standard Care
The baby is placed on the mother's lap 2 minutes before the procedure and the mother is provided to hold the baby effectively and graspingly. Standard heel lance procedure is applied. No additional interventions are applied to the baby. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.
结局指标
主要结局
Neonatal Infant Pain Scale (NIPS)
时间窗: during the heel lance
Turkish validity and reliability were established. Reliability values were found to be 0.83, 0.83, 0.86 before, during and after the procedure, respectively. Newborn infant pain scale is a likert-type scale consisting of 6 parameters, facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; groaning, 2; loud crying), breathing (0; comfortable, 1; variable-irregular), arm (0: relaxed-free, 1; flexion-extension), leg (0; comfortable-free, 1; flexion-extension) and sleep-wake (0; sleeping-waking peaceful, 1; restless).
The Newborn Comfort Behavior Scale (NEAS)
时间窗: during the heel lance
The newborn comfort behavior scale is a Likert type scale developed to evaluate the comfort needs, pain and distress of newborn babies.his scale consists of six parameters: alertness, agitation, respiratory response/crying, body movements, facial tension and muscle tone.
次要结局
未报告次要终点
研究者
Gülçin Özalp Gerçeker
Assoc. Prof.
Dokuz Eylul University