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Completed

NCT Number: NCT04381572

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samodzielny Publiczny Szpital Kliniczny nr 1

Zabrze, Silesian Voivodeship, 41-800, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High fidelity simulation training

Behavioral

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.

Primary outcomes

  1. Α-amylase activity in saliva [U/ml]

    Time frame: 120 minutes

    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.

  2. Secretory immunoglobulin class A concentration in saliva [ug/ml]

    Time frame: 120 minutes

    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).

  3. Cortisol concentration in saliva [ng/ml]

    Time frame: 120 minutes

    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).

  4. Testosterone concentration in saliva [pg/ml]

    Time frame: 120 minutes

    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).

  5. Total protein concentration [mg/ml]

    Time frame: 120 minutes

    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.

Secondary outcomes

  1. Heart rate [bpm]

    Time frame: 120 minutes

    Heart rate was measured using a cardiomonitor (Infinity Delta, Dräger; Germany).

  2. Blood pressure [mmHg]

    Time frame: 120 minutes

    Blood pressure was measured using a cardiomonitor (Infinity Delta, Dräger; Germany).

  3. Saturation [%]

    Time frame: 120 minutes

    Saturation level was measured using a cardiomonitor (Infinity Delta, Dräger; Germany).

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 11, 2020
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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