The Efficiency of Using Supportive Postures and Holding Techniques in Order to Minimize Premature Infant Pain During Naso-gastric Tube Insertion, in the Presence or Absence of the Mother.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Pain during insertion of the probe
研究概览
简要总结
Out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. The pain is often under estimated due to the frequency with which the procedure is carried out. It has been shown that the environment in which the procedure is performed (e.g with skin to skin contact and specific positioning), reduces the discomfort felt by the newborn. However, this has not yet been proven with regards to naso-gastric tube insertion.
详细描述
Our clinical study (carried out in the Neonatology Unit of Mercy Regional Hospital) has shown that when positioning and other non drug related analgesic techniques are used, newborns undergoing naso-gastric tube insertion feel less pain.
Several different techniques were used, such as skin-to-skin contact with the mother and/or positioning the infant using appropriate equipment, or the "four hands" technique carried out by two health care professionals.
Neonatal unit staff were able to choose the method used depending on whether the mother was present at the time of the procedure.
In cases where the mother was absent, the "four hands technique" was favored, but in the presence of the mother skin-to-skin contact was preferable.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm baby born between the 32th and the 35th weeks of amenorrhea plus 6 days
- •Prescription of enteral nutrition via naso-gastric tube
- •Naso-gastric tube in-situ
- •Informed consent of both parents
排除标准
- •For the newborn
- •Under respiratory assistance
- •With nasal or buccal malformation
- •With abnormal heart rhythm or congenital heart disease
- •With hemodynamic instability
- •Transfer to type 3 neonatal unit
- •With a DAN score > 0 before treatment
- •With an umbilical venous catheter in-situ
- •Fed with thickened milk
- •Prescription of analgesic medications
- •For the parents
- •Under legal protection
- •Difficulties which do not permit the mother to carry out skin-to skin contact or holding support
研究组 & 干预措施
Skin-to-skin support
The newborn is dressed in one layer of clothing with a hat, he is placed in the ventral position directly on the mother's chest, covered with a warm blanket and held in place with a band during the insertion of the naso-gastric feeding tube.
干预措施: Installation of a naso-gastric feeding tube (Other)
Holding
The newborn is held in his mother's arms during insertion of the naso-gastric feeding tube.
干预措施: Installation of a naso-gastric feeding tube (Other)
Four hands care
Carried out by two professionals: one health-care professional supports the child and helps stabilize the newborn whilst the other professional inserts the naso-gastric feeding tube.
干预措施: Installation of a naso-gastric feeding tube (Other)
Containing support with equipment
Carried out by one healthcare Professional, who places the newborn in such a manner that he will be held in the optimum position (using a soft sheet) during the insertion of the naso-gastric feeding tube.
干预措施: Installation of a naso-gastric feeding tube (Other)
结局指标
主要结局
Pain during insertion of the probe
时间窗: Day 1
Evaluation of the newborn's pain during insertion of the naso-gastric tube using the Premature Infant Pain Profile (PIPP) scale. The PIPP consists of 3 behavioral (facial actions: brow bulge, eye squeeze, and nasolabial furrow) and 2 physiological (heart rate and oxygen saturation) indicators, and 2 contextual \[gestational age (GA) and behavioral state\] variables that modify pain. In the same time, the heart rate and oxygen saturation of the newborns were measured using a pulse oximeter.
次要结局
- Evaluation of pain using the DAN scale(Day 1)
- Maternal satisfaction(Day 1)
- Duration of the Naso -gastric tube in situ(Day 7)
- Professional's satisfaction(Day 1)
- Procedure time(Day 1)