The Impact of High Fidelity Simulation on Stress Level in Medical Students.

Stress, Physiological Clinical Trial

Official title:

The Impact of High Fidelity Simulation on Stress Level in Medical Students.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04381572
• Other study ID #: SSS-01
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• High Fidelity Simulation Training
• Stress, Physiological

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