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

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.

Study Overview

• Status: Completed
• Conditions: Stress, Physiological; High Fidelity Simulation Training
• Intervention / Treatment: Behavioral: High fidelity simulation training

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Poland
  • Silesia
    • Zabrze, Silesia, Poland, 41-800
      • Samodzielny Publiczny Szpital Kliniczny nr 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Medical faculty students (fifth and sixth year) scheduled to undergo high fidelity medical simulation as a part of standard scholastic program.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

High fidelity simulation training; Group consisting of medical students scheduled to undergo high fidelity medical simulation as a part of standard scholastic program.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Α-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. Α-amylase activity assay was performed by a static method with AMYLAZA kit (Aqua-Med Łodz, 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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate [bpm]	Heart rate was measured using a cardiomonitor (Infinity Delta, Dräger; Germany).	120 minutes
Blood pressure [mmHg]	Blood pressure was measured using a cardiomonitor (Infinity Delta, Dräger; Germany).	120 minutes
Saturation [%]	Saturation level was measured using a cardiomonitor (Infinity Delta, Dräger; Germany).	120 minutes

Collaborators and Investigators

• Sponsor: Medical University of Silesia

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SSS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No