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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04041635
Study type Interventional
Source Germans Trias i Pujol Hospital
Contact Sergio Alonso-Fernández, RN
Phone 0034934978437
Email salonso.germanstrias@gencat.cat
Status Recruiting
Phase N/A
Start date July 1, 2019
Completion date December 2022

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