The influence of music on pain and physiological responses in sedated patients.

INTERVENTION: E02.190.888.500 It is a randomized placebo‐controlled trial in which the control of the research was the absence of music. The study was conducted in 18 patients admitted in the Adult Intensive Care Unit of a public hospital in the Federal District from April to June 2017. Earphones were coupled to these patients and it was plugged into MP3 players with inserted flash drives (named as exposure); each flash drive has contained a MP3 file, in order to analyze the influence of the exposed music. Inclusion criteria considered patients with continuous sedation, in using mechanical ventilation through an orotracheal tube, with stable hemodynamics and preserved auditory acuity. Exclusion criteria included patients in procedure of the extubation, during blood transfusion and/or dialysis, in use of vasoactive drugs and/or of thermal mattress or blanket, if the sedation was switched off, patients death. The patients included in the study were separated into Intervention group (named as group A ‐ with music use) and Control group (named as group B ‐ without use of music) according to the random choice of flash drive on each day of collection. Therefore, each patient was submitted to the exposure in two consecutive days, and the same participant could be part of the intervention group on the first day of collection and the control group on the second day, or from the same group on the two days of collection. After the second day of collection in the same patient, he/she was not used for the research again. Eighteen patients were evaluated, of which 14 were compatible with the inclusion criteria of the study and 04 were incompatible with these criteria. This research did not have as main focus the evaluation of the number of participants per group but, the number of exposures performed per group (intervention and control). Thus, each exposure occurred for 30 minutes, with a maximum of 02 auditions per patient, in a subsequent 02 days, in a total of 36 exposures during the study period, CONDITION: C10.597.617 E02.041.625 E02.190.888.500 E03.295 N02.278.388.493 Patients hospitalized in an Intensive Care Unit with continuous sedation, using mechanical ventilation by means of an orotracheal tube, with stable hemodynamics and preserved auditory acuity. Excluded patients in blood transfusion, during dialysis, using vasoactive drugs, in the use of a mattress or thermal blanket, if the sedation was turned off, the extubation or death procedure was performed. Specific Descriptors: Music therapy, pain, intensive care unit, artificial respiration, deep sedation, pathological conditions, signs and symptoms ; E02.190.888.500 ; C10.597.617 ; N02.278.388.493 ; E02.041.625 ; E03.295 PRIMARY OUTCOME: Outcomes effectively observed at the end of the study: there was no decrease in pain levels in the 01‐hour‐per‐day of each data collection verified by means of the Kolmogorov‐Smirnov test, ANOVA, t test, Friedman non‐parametric test and the Mann‐ Whithney from p values greater than 0.05 in pre and post intervention measurements. Primary outcome expected: decreased pain levels in the 01‐hour‐per‐day period of each data collection verified by means of the Kolmogorov‐Smirnov test, ANOVA, t‐test, Friedman non‐parametric test and the Mann‐Whithney test From p values less than or equal to 0.05 in pre and post intervention measurements. SECONDARY OUTCOME: Expected secondary outcomes: decreased vital signs (systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate, oxygen saturation and axillary temperature) in the 01 hour per day period of each data collection verified through the evaluation of the results of the Kolmogorov‐Smirnov tests, ANOVA, t test, Friedman's non‐parametric test and the Mann‐Whithney test from p values less than or equal to 0.05 in pre and post intervention measurements. Outcomes effectively observed at the end of the study: reduction over time in systolic blood pressure and axillary temperature, in the group with music in the period from 01 hours per day at a data collection verified by evaluating the results of the Kolmogorov‐Smirnov test, ANOVA, t‐test, Friedman's non‐parametric test and the Mann‐Whithney test from p values less than or equal to 0.05 in pre and post intervention measurements. INCLUSION CRITERIA: Patients of both genders; Age above 18 years; With continuous sedation; In use of mechanical ventilation by means of an orotracheal tube; With stable hemodynamics; Preserved auditory acuity.