Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in the Premature Infant Pain Profile (PIPP) score
研究概览
简要总结
The aim of the study is: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation.
详细描述
Background: The evidence for the efficacy of reducing sensory stimulation and its effect on pain in minor procedures has not been studied in depth. There are no studies that evaluate the reduction of visual and auditory stimuli in a combined way.
Impact: It is easy to incorporate the reduction of visual and auditory stimuli into nursing practice.
Aims: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation.
Design: Open, randomized, non-blind parallel clinical trial. Methods: Study to take place at the neonatal intensive care unit at the Germans Trias i Pujol University Hospital in 2019-2021. 56 recently born babies between 32 and 36 weeks of gestation will participate. The dependent variable is level of pain determined using the Premature Infant Pain Profile (PIPP). The intervention will be assigned randomly using the random.org software. Data analysis will be carried out using the IBM SPSS v.25 software assuming a level of significance of 5%.
The results of this study could have a direct impact on clinical practice.
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
- 32 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature babies born between 32 and 36 weeks of gestation (both included).
- •Haemodynamically stable.
- •Require venipuncture and whose.
- •Parents or legal guardians have signed informed consent forms.
排除标准
- •Gestational age inferior to 32 weeks.
- •Treated with intravenous or oral analgesics, sedatives or relaxants.
- •Critical status or haemodynamically unstable.
- •Requiring invasive mechanical ventilation.
研究组 & 干预措施
Stimuli Reduction
This group will receive reduced visual and auditory stimuli in addition to usual care during venipuncture. Phototherapy goggles and earmuffs will be placed 3 minutes before the venipuncture (leaving the patient in resting state after the manipulation) and will be maintained during the procedure. Monitor alarms and devices will be silenced and will remain silenced and noise in the unit will be minimized during the procedure.
干预措施: Stimuli reduction (Procedure)
Usual Care
Babies in the control group will receive physical contention with administration of sucrose two minutes before carrying out the venipuncture procedure (usual care). Venipuncture will be performed with 22G extraction needles, or peripheric venous catheter. During the puncture the eyes will not be covered, and monitor alarms and devices be not be silenced.
干预措施: Usual care (Procedure)
结局指标
主要结局
Change in the Premature Infant Pain Profile (PIPP) score
时间窗: From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture
Calculation of pain response using a validated instrument (Premature Infant Pain Profile-PIPP). It varies from "0" (no pain to 21 (maximum pain response)
次要结局
- Change in heart rate(From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture)