Satisfaction With an In-house Developed Nasal Foreign Body Removal Manikin: A Randomized-controlled Trial
Phase: NA
Conditions: Satisfaction, Consumer Satisfaction
Sponsor: Prince of Songkla University

 
 
 
SATISFACTION WITH AN IN-
HOUSE DEVELOPED NASAL 
FOREIGN BODY REMOVAL 
MANIKIN: A RANDOMIZED-
CONTROLLED TRIAL 
10 Feb 2021 
pittayapon pitathawatchai 
[Email address] 
NCT04901026 
Unique Protocol ID: 64-019-13-1 

Background: Nasal foreign bodies can lead to life-threatening conditions. Hence, it is 
a necessity that physicians be well trained in the appropriate procedures for removal of nasal 
foreign bodies. However, training on real patients is not only unpractical it is also too 
dangerous, due to risk of foreign body aspiration during the procedure. 
Objective: To construct a manikin, with a specific design, to serve all possible needs for training. 
Design: A randomized controlled trial with a crossover design. 
Methods: The in-house manikin was developed from 2 materials; flexible polyurethane  
foam and silicone. Silicone, which has elasticity similar to nasal alae, was used to 
develop the detachable nose and nasal cavity, whilst polyurethane foam, which is light and 
easy to carry, was used to develop the head. The in-house manikin was compared with 
a commercial manikin for satisfaction after a nasal foreign body removal procedure was 
performed in both groups, by 37 physicians, after conducting a randomized controlled trial 
with a crossover design. 
Statistical analysis: A Wilcoxon signed-rank test was used to compare the satisfaction scores  
between the in-house and commercial manikin. A P value lower than 0.05 was considered as 
statistically significant. Simple and multiple linear regression were used to assess which variables  
were independently associated, with a total satisfaction score difference between the inhouse and  
commercial manikins. Baseline characteristics, including medical specialty, age, gender, time  
experience as a general physician or an ENT specialist, were assigned as independent variables. The  
total satisfaction score difference between the in-house and commercial manikins was assigned as a  
dependent variable. This total satisfaction score difference was calculated from a different value of  
score summations in each dimension between the in house and commercial manikins. The Shapiro– 
Wilk test was used to test the normality of the dependent variables. In the simple regression analysis,  
a threshold of a p value less than 0.1 was used to identify candidates for inclusion in the multiple  
linear regression.