The Effect of Using Illustrated Communication Material on Anxiety and Comfort in Communication With Patients Receiving Mechanical Ventilator: Randomised Controlled Clinical Trial
Phase: NA
Conditions: Anxiety, Comfort, Communication
Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

 
 Name of the Research: The Effect of Using Illustrated Communication Material on Anxiety 
and Comfort in Communication with Patients Receiving Mechanical Ventilation Support: A 
Randomized Controlled Clinical Study  
Date of the Document: 11.01.2017  

Objective: In communication with patients receiving mechanical ventilation support, to 
determine the effect of the use of illustrated communication material on the anxiety and 
comfort levels of these patients. Study design: This study was planned as a randomized 
controlled clinical trial with two arms: Patients who had undergone cardiac surgery were 
randomly assigned to intervention (illustrated communication material were used) and control 
(routine methods in the communication were used) groups when they were connected to the 
mechanical ventilator. Setting and Participant: The study was conducted in the 
Cardiovascular Surgery Clinic of a Training and Research Hospital in Ankara, Turkey 
between 15 July 2016 and 15 June 2017. The sample of the research consisted of patients 
undergoing cardiac surgery. This patient population was preferred because the initiation and 
termination of mechanical ventilation therapy in patients undergoing cardiac surgery were 
carried out within a specific time frame and within certain standards, except for exceptional 
cases. The sample size of the study was calculated with the Sample Size Calculators package 
program of DSS Research (https://www.dssresearch.com). Since this research is the first 
research on the subject, a reference value for the impact value could not be reached. 
Therefore, a total of 20 patients, ten from the control group, and ten from the intervention 
group were piloted. Considering that the mean comfort score is 87.1 ± 13.7 in the control 
group and 110.8 ± 9.2 in the intervention group, it was calculated that there should be at least 
eight patients in each group with 95% confidence interval, 99% power, 0.05 Type I error, 0.01 
Type II error for the difference between groups. However, considering the other parameters to 
be measured in the research and the sample size criterion required to perform parametric 
testing, a total of 60 patients, 30 in each group, formed the sample size. As there was no 
change in the data collection method, patients who were in pre-application were included in 
the study. The inclusion criteria of the patients were as follows: having undergone cardiac 
surgery; having mechanical ventilation therapy; being 18 and over; having a minimum of -2 

and a maximum of +2 from the Richmond Agitation Sedation Scale (RASS); to agree to 
participate in the research. Criteria of exclusion of patients from the study were: not speaking 
Turkish; having vision and hearing loss; having a cognitive or psychological problem 
preventing them from communicating; having previous intubation experience; undergoing 
revision surgery because of bleeding in the early stages of the postoperative period or 
development of a complication such as needing additional sedation. Randomization: Weekly 
randomization was performed since the use of different communication techniques at the 
same time may confuse during the intensive care period of the research. “Which method to be 
used in which week” was determined by block randomization with groups of 2 in the "R" 
Studio program. Blindness: In the study, blindness could not be achieved because patients 
were followed up in a common area in intensive care after the operation, communication with 
the patient was established more than once in line with the needs of the patient and the 
material was visible 

Name of the Research: The Effect of Using Illustrated Communication Material on Anxiety 
and Comfort in Communication with Patients Receiving Mechanical Ventilation Support: A 
Randomized Controlled Clinical Study  
Date of the Document: 11.01.2017  

Data analysis: Statistical Package of Social Sciences (SPSS, Inc., Chicago, IL, USA) 15.0 
package program was used to evaluate the data. Descriptive statistics for variables that were 
calculated by counting were presented as number and percentage (%) and for variables that 
were calculated by measurement were presented as mean ± standard deviation ( ± SS) or 
median and minimum-maximum (min-max) values. The normality of the measurement values 
was evaluated with the Single Sample Kolmogorov Smirnov test. Accordingly, in the 
investigation of the difference between the two groups, "Independent Sample T-Test" was 
used for the data that fit the normal distribution, and the "Mann Whitney U Test" was used for 
those that did not fit to normal distribution. In the evaluation of repeated measurements, 
"Dependent Sample T-Test" was used for measurements that fit the normal distribution, and 
the "Wilcoxon Signed Rank Test" was used for those who did not fit to the normal 
distribution. The "Chi-square Test" was used to show the difference between the variables 
determined by counting. In the presence of fewer than five values observed in one of the cells, 
the “Fisher Exact Chi-square Test” was taken as the basis. p <0.05 value was accepted as an 
indicator of statistical significance.  

Name of the Research: The Effect of Using Illustrated Communication Material on Anxiety 
and Comfort in Communication with Patients Receiving Mechanical Ventilation Support: A 
Randomized Controlled Clinical Study  
Date of the Document: 11.01.2017