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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04381572
Other study ID # SSS-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date June 30, 2017

Study information

Verified date May 2020
Source Medical University of Silesia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

High fidelity simulation (HFS) is an established method of training in various fields of medicine, especially emergency medicine, anesthesiology and intensive therapy. One of the benefits of HFS as an educational tool is the protective environment, where the risk of error do not bring harm to the patients.

It is proven that HFS is successful in acquisition of new knowledge and skills and may facilitate positive behavioral change in medical students. However, this education method may cause elevated stress levels as well as other physiological reactions. Other than sympathetic nervous system reactions such as heart rate and blood pressure, there are a few laboratory stress level markers such as cortisol, alpha-amylase, testosterone and secretory immunoglobulin A. Our aim was to evaluate the change of stress level induced by high-fidelity simulation in medical students.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- willingness to take part in the study

Exclusion Criteria:

- pregnancy,

- active infections

- diseases of immune system

- metabolic or endocrine disturbances

- current use of any medication (except for oral contraceptives)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
High fidelity simulation training
At the beginning of scheduled classes in the simulation center, students were placed sitting at rest for 30 min. In each team a leader was chosen. Other team members were also assigned detailed functions. Before starting the scenario, participants were oriented for 10 -15 minutes by a physician instructor about the simulation room setup and manikin features. The simulated scenarios were performed using a high fidelity computer-based manikin simulator, with the possibility of remote control of vital signs. All medications and equipment required during the clinical scenarios were available. The scenario used was prepared and validated by experienced simulation instructors. All student groups were given the same standardized scenario.

Locations

Country Name City State
Poland Samodzielny Publiczny Szpital Kliniczny nr 1 Zabrze Silesia

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary ?-amylase activity in saliva [U/ml] Saliva was collected using a disposable Salivette tube (Sarstedt AG & Co, Germany) by placing a sterile tampon under the tongue or chewing for 30-45 seconds. Next the tube was centrifuged (1000 x g for 10 min.) to obtain a ready to test saliva supernatant. Samples were frozen after centrifugation at - 85°C until performing laboratory tests. ?-amylase activity assay was performed by a static method with AMYLAZA kit (Aqua-Med Lodz, Poland). The samples were diluted 100 times using 0,9% chloride solution. 2-chloro-4-nitrofenylo-maltotrioside is a substrate in this method. The reaction was performed in pH 6,0 MES buffer at 37 ° C rendering a colored reaction product. The product was then analyzed via spectrophotometry at 405 nm. 120 minutes
Primary Secretory immunoglobulin class A concentration in saliva [ug/ml] Saliva was collected using a disposable Salivette tube (Sarstedt AG & Co, Germany) by placing a sterile tampon under the tongue or chewing for 30-45 seconds. Next the tube was centrifuged (1000 x g for 10 min.) to obtain a ready to test saliva supernatant. Samples were frozen after centrifugation at - 85°C until performing laboratory tests. Determination of secretory immunoglobulin class A (sIgA) concentration was established using an ELISA (Immunodiagnostic AG, Germany). The analytical procedure was carried out in accordance to the instructions provided by the manufacturer in the user manual. Absorbance readings were taken using a µQuant reader (BioTek, USA), the results were processed using the KCJunior program (BioTek, USA). 120 minutes
Primary Cortisol concentration in saliva [ng/ml] Saliva was collected using a disposable Salivette tube (Sarstedt AG & Co, Germany) by placing a sterile tampon under the tongue or chewing for 30-45 seconds. Next the tube was centrifuged (1000 x g for 10 min.) to obtain a ready to test saliva supernatant. Samples were frozen after centrifugation at - 85°C until performing laboratory tests.
The commercial ELISA (Diapra, Italy) were used to determine the concentration of cortisol in saliva. The analytical procedure was carried out with accordance to the manufacturer's instructions in the technical manual supplied with the kit. Absorbance readings were taken using a µQuant reader (Biotek, USA), while results were processed using KCJunior (Biotek, USA).
120 minutes
Primary Testosterone concentration in saliva [pg/ml] Saliva was collected using a disposable Salivette tube (Sarstedt AG & Co, Germany) by placing a sterile tampon under the tongue or chewing for 30-45 seconds. Next the tube was centrifuged (1000 x g for 10 min.) to obtain a ready to test saliva supernatant. Samples were frozen after centrifugation at - 85°C until performing laboratory tests.
The commercial ELISA (Diapra, Italy) was used to determine the concentration of testosterone in saliva. The analytical procedure was carried out with accordance to the manufacturer's instructions in the technical manual supplied with the kit. Absorbance readings were taken using a µQuant reader (Biotek, USA), while results were processed using KCJunior (Biotek, USA).
120 minutes
Primary Total protein concentration [mg/ml] Saliva was collected using a disposable Salivette tube (Sarstedt AG & Co, Germany) by placing a sterile tampon under the tongue or chewing for 30-45 seconds. Next the tube was centrifuged (1000 x g for 10 min.) to obtain a ready to test saliva supernatant. Samples were frozen after centrifugation at - 85°C until performing laboratory tests. To determine the total protein concentration the Lowry method was used. This method base on the reactions between peptide bonds, tyrosine and Folin-Ciocalteu reagent. The absorbance of the resulting color was read at a wavelength of 650-750 nm, 30 minutes after the addition of the reagent. Bovine serum albumin water solution (BSA - Sigma Aldrich, Germany) at slightly basic pH was used as standard. 120 minutes
Secondary Heart rate [bpm] Heart rate was measured using a cardiomonitor (Infinity Delta, Dräger; Germany). 120 minutes
Secondary Blood pressure [mmHg] Blood pressure was measured using a cardiomonitor (Infinity Delta, Dräger; Germany). 120 minutes
Secondary Saturation [%] Saturation level was measured using a cardiomonitor (Infinity Delta, Dräger; Germany). 120 minutes
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