COMPARISON OF THE EFFECTIVENESS OF GLUCOSE AND REFLEXOTHERAPY IN THE RELIEF OF PAIN IN NEWBORNS IN A NEONATAL INTENSIVE CARE UNIT: randomized clinical trial.
Glucose. Reflexotherapy. Pain management. Infant, newborn. Intensive care units, neonatal.
Newborns are exposed to a range of painful procedures in the Neonatal Intensive Care Unit, requiring measures to alleviate pain. The non-pharmacological treatment of pain seeks to reduce aggressive stimuli from the environment, preventing physiological and behavioral changes, generating breath and reducing stress. From this perspective, this study aims to compare the effectiveness of 25% glucose solution and reflexotherapy in relieving pain in neonates admitted to the Neonatal Intensive Care Unit during arterial puncture. This is a double-blind, randomized controlled clinical trial carried out with newborns who have an indication for blood collection by arterial puncture who are hospitalized in neonatal intensive care at a reference school maternity hospital for high-risk pregnancy and delivery in Natal, Large northern river. The sample will be divided into two groups, Control Group and Intervention Group, in which the Control Group will receive 25% oral glucose solution, and the Intervention Group will receive foot reflex therapy. Considering the Cohen effect size of 0.40, test power of 0.80 and a significance level of 5%, there is a sample of 26 neonates per group, totaling 52 participants. The research inclusion criteria are: newborns (up to one week old) ≥ 32 weeks of gestational age or weighing ≥ 1500g who are requested laboratory tests/gasometry/blood culture through arterial puncture. To ensure the randomization of study participants, the website www.randomization.com will be used, which will previously select the participants for each group by simple randomness and without the influence of the researchers. The data collection instrument is structured in three parts: data on the mother; birth and newborn data; pain assessment in the arterial puncture procedure using the Neonatal Infant Pain Scale-Brasil and other parameters. The project was submitted for authorization by the direction of the maternity school and forwarded for approval by the Research Ethics Committee of the Federal University of Rio Grande do Norte, CAAE 23720419.5.0000.5537 and was registered in the Brazilian Registry of Clinical Trials under the number RBR-639bff. The collected data will be stored and analyzed through a computerized database using Microsoft Office Excel and Statistical Package for the Social Sciences version 20.0 software. The aim is to promote new knowledge about interventions that are more suitable for the relief of neonatal pain during painful procedures.