Population
This is a cross sectional study with repeated measures in which the vital signs’ fluctuations have been detected in ninety-seven TBI patients hospitalized at the ICU section of PoorSina hospital, Rasht, Iran. Members of the population were chosen by consecutive sampling method. A sample size of fifty-seven patients was determined using Cochran equation in which confidence level and test’s power were considered 95% and 90%, respectively. Then, five cases for each disturbing variable were added to the sample size according to the eight disturbing variables found in this study. The final population size included ninety-seven patients.
Ethical considerations
To meet ethical considerations, the purpose of the study was explained to either patients or their companions, making them sure that patients’ information will be kept anonymous and be used without their names or any pictures. This study was approved at the ethical committee of Guilan University of Medical Sciences, Rasht, Iran (IR.GUMS.REC-1396.88).
Inclusion criteria
Age ≥18, being hospitalized in ICU following TBI ≥ 24 hours, GCS≥13, the consent of the patients or their companions.
Exclusion criteria
Any kind of injury or any change in peripheral nervous (motor paralysis, spinal cord injury, or taking nervous blocking agents), any background for chronic drug misuse (based on the medical records), delirium (according to medical records), non-available medical information.
Data collection tools
In this study, data collection tools included demographic characteristics (age, gender, career, education), disease-related condition (detection, GCS, drowsiness level, type and dosage of analgesic and sedative medicines, and the cause, location, and intensity of pain). Drowsiness level was monitored using RASS. To begin with, patients were visited without any involvement and if conscious, the scores 0-4 were given to them. Unconscious patients were called by researchers and -1 to -3 points were considered based on their responses. When no response was observed, their shoulders were shaken and if there was no answer, their sternums were strongly squeezed and an appropriate point from -5 to -4 was recorded.
The severity of pain was detected using CPOT score. This checklist included five categories of facial expression, body movements, muscle stretching, and the ability to talk in non-intubated patients, and adaptation to ventilation. Each behavior had (0-2) scores and the total scores were (0-8). A total score equal to zero was the minimum score and implied “without pain”. Scores 1-3 and 4-5 defined mild pain and moderate pain, respectively. The maximum scores (6 and above) belonged to uncontrolled severe pain. the sum of behavioral changes’ scores were calculated by CPOT, a standard tool whose validity and reliability are proved in several studies (19,20) .
In this study, face pain thermometer (FPT) was used after either painful or non-painful stimuli and was prepared by the researcher. Vital signs’ table (including heart rate, blood pressure, arterial blood oxygen, and respiration) was prepared before, during, and after both painful (change in position) and non-painful (non-invasive blood pressure (NIBP)) stimuli.
Data Collection
Patient’s vital signs were incessantly monitored. NIBP was induced by filling the cuff when. Patients were visited during the NIBP procedure and the following position change as a non-painful stimulus. The supervision periods of 1 min, 2 mins, and 15 mins were carried out before, during, and after each procedure with total six evaluation items. At first, patients were visited as a baseline (1 min) and vital signs, as well as behavioral responses, were recorded by a researcher. The accuracy of the evaluation was checked by the assistance of an expert who was asked to fill the CPOT forms separately. Then, the NIBP procedure was carried out and the patients were visited during the last two minutes and their items were recorded again before the final record after 15 mins.
The ability to self-report was evaluated by directly asking patients without delirium who was able to communicate and had GCS ≥13 so that they would express the existence (yes/no) and the intensity (0-10 points) of their pain. Afterward, they were asked to score their pain using a 10-score pain scale. Following NIBP, the painful test was done and the vital signs were documented at 1, 2, and 15 mins. Moreover, the ability to self-report was assessed as NIBP test. It has to be mentioned that an expert supervised all stages and filled the CPOT forms separately.
Statistical analysis
The data were entered to SPSS V. 23 software. Qualitative variables were described using frequency and frequency percentage while quantitative variables were presented using mean, standard deviation, maximum, minimum, median, and confidence interval 95%. Mean, standard deviation, Bonferroni’s test, and Greenhouse-Geisser test were used in order to compare behavioral responses before, during, and after both painful and non-painful stimuli. The potential relationships between pain and either behavioral responses or vital signs’ fluctuations were evaluated using multilinear regression for studied variables based on the general linear model using GEE method and with the control of disturbing factors. p<0.05 was considered as statistically significant.