Reduction of visual and auditory stimuli to reduce pain during venipuncture in premature infants. Study protocol for a randomized controlled trial

Aim 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. Method Study to take place at the neonatal intensive care unit of a University Hospital in 2019–2021. Fifty‐six recently born babies between 32‐36 weeks of gestation will participate. The dependent variable is the level of pain determined using the premature infant pain profile instrument. 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%. Discussion 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. The results of this study could have a direct impact on clinical practice. Trial registered at clinicaltrials.gov: NCT04041635 目的 评价减少视觉和听觉刺激对32˜36周妊娠早产儿静脉穿刺疼痛的影响 设计 开放式随机非盲平行临床试验。 方法 2019年至2021年期间,对某大学附属医院新生儿重症监护室开展该研究。56名32~36周妊娠早产儿参与了该研究。依变量是使用早产儿疼痛曲线仪确定的疼痛水平。 讨论 尚未深入研究在小手术中减少感官刺激的有效性及其对疼痛的影响。目前尚无有关以综合方式评估视觉和听觉刺激减少的研究。 影响 将减少视觉和听觉纳入护理实践中是很容易实现的。该研究结果可能会对临床实践产生直接影响。 试验注册地址 clinicaltrials.gov;注册编号:NCT04041635