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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Stress, Physiological, High Fidelity Simulation Training

Being tested

High fidelity simulation training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• High fidelity simulation trainingBehavioural

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: 120 minutes

2. 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).

   Measured: 120 minutes

3. 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).

   Measured: 120 minutes

4. 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).

   Measured: 120 minutes

5. 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.

   Measured: 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted11 May 2020
2. Study start1 Apr 2017
3. Primary completion30 Jun 2017
4. Study completion30 Jun 2017

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Stress, PhysiologicalStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.