How does practising simulated emergency medical situations physically and mentally affect medical students?
| ISRCTN | ISRCTN32132176 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32132176 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PI-033/18 |
| Sponsor | Universidad de Valladolid |
| Funder | Investigator initiated and funded |
- Submission date
- 25/12/2019
- Registration date
- 03/01/2020
- Last edited
- 24/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
The world of teaching of Health Sciences is experiencing a revolution. Virtual reality and other simulation technologies are a powerful tool teaching and training of future healthcare professionals in techniques, procedures and skills. Current and future generations of students have integrated the use of mobile devices and computer technologies into their daily lives, and are very used to interacting with a virtual environment. Advanced clinical simulations provide two substantial advantages. The first is patient safety, since the student can repeat the techniques that they did not fully master. The second advantage is that their performance can be recorded, which enables detailed feedback from instructors.
This study aims to investigate the physical responses and perceptions of medical students participating in an Advanced Clinical Simulation Subject.
Who can participate?
Students in the final year of a Medicine degree
What does the study involve?
Students who have agreed to participate will fill out questionnaires to assess their anxiety level, level of physical activity and lifestyle habits. They will also have their heart rate, blood pressure and temperature measured and will provide a saliva sample and a have a finger-prick to collect a drop of blood. They will then be randomly allocated to perform one of four simulated medical situations as either the leader or assistant in a team of two students. After the simulation, they will repeat the tests from before the simulation.
What are the possible benefits and risks of participating?
There are no direct benefits to participants, but this research should benefit future students in helping to identify those who might develop anxiety during the simulation. The study has no risks apart from the pain potentially involved in the finger prick.
Where is the study run from?
University of Valladolid (Spain)
When is the study starting and how long is it expected to run for?
September 2019 to June 2021
Who is funding the study?
The study is funded by the researchers themselves.
Who is the main contact?
Dr Francisco Martín-Rodríguez, fmartin@saludcastillayleon.es
Contact information
Scientific
Facultad de Medicina
Universidad de Valladolid
Avda. Ramón y Cajal 7
Valladolid
47005
Spain
 ORCID ID |
0000-0002-1773-2860 |
|---|---|
| Phone | +34 686452313 |
| fmartin@saludcastillayleon.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomized controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomized controlled clinical trial on the influence of physiological, metabolic and anxiety parameters on high fidelity clinical simulation |
| Study acronym | ACSC-ax |
| Study objectives | The anxiety that students endure when carrying out a case of advanced clinical simulation can influence the physiological and metabolic sphere. |
| Ethics approval(s) | Approved 10/04/2018, Comité de Ética de la Investigación con medicamentos (CEIm) Area de Salud de Valladolid Oeste [Drug Research Ethics Committee of West Valladolid Health Region] (Río Hortega University Hospital, Dulzaina 2, 47012 Valladolid, Spain; +34 983 420 400; rconvi@saludcastillayleon.es), ref: PI033-18 |
| Health condition(s) or problem(s) studied | Metabolic and physiological fatigue |
| Intervention | There are 4 simulation scenarios. Each case will be solved by two students, one will act as a team leader and the other as an assistant, solving the situation according to the pre-established protocols and procedures for the management of each pathology. The cases are of similar difficulty, and all have a maximum duration of 10 min. Before starting any of the cases, it will be explained to the students that they must perform the techniques and procedures in the simulator as correctly as possible. Once the students are in the debriefing classroom and have signed the informed consent, they must fill out a form to describe their basal level of anxiety (STAI questionnaire), and proceed to the baseline taking of heart rate, systolic and diastolic blood pressure, tympanic temperature, saliva pH, capillary lactic acid, and to fill in a brief epidemiological survey, asking about lifestyle habits (alcohol, tobacco, coffee, etc.). In addition, weight and height are measured and they perform the International IPAQ Physical Activity Questionnaire. Through the XLAT BIOMED program a randomization of the clinical case that should be performed and the role (leader or assistant) was performed. The clinical simulation scenarios proposed and that will be randomized are: 1. Young woman, with a poorly tolerated supraventricular tachycardia 2. Elderly woman, with a drug poisoning by benzodiazepines 3. Elderly male, in a coma due to a hypoglycemia situation 4. Young male, with arm and leg burns and smoke inhalation At the end of the simulation and just before debriefing the two students who have done the case (team leader and assistant) perform a new STAI questionnaire and have heart rate, systolic and diastolic blood pressure, tympanic temperature, pH in saliva and capillary lactic acid measured again. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Heart rate, assessed using a Physio LifePAK® 15 monitor, immediately before and after the simulation |
| Key secondary outcome measure(s) |
The following are assessed before and after the simulation: |
| Completion date | 10/06/2021 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 180 |
| Key inclusion criteria | 1. Aged 18-65 years 2. Students of the Faculty of Medicine in the 4th, 5th or 6th year of the course |
| Key exclusion criteria | 1. Basal heart rate greater than 120 or less than 35 beats per min 2. Systolic or diastolic blood pressure greater than 160 or 95 mmHg respectively 3. Systolic blood pressure less than 80 mmHg 4. Body mass index greater than 40 kg/m2 5. Severe visual or hearing impairment 6. Disability or injury that prevents the participant from physically conducting the simulation 7. Capillary hemoglobin less than 8 g/dl 8. Temperature greater than 38º C 9. Major surgery up to 30 days before 10. Cutaneous diseases in acute phase 11. Epilepsy 12. Anticoagulation 13. Infections in progress 14. Systemic immunological diseases |
| Date of first enrolment | 10/10/2019 |
| Date of final enrolment | 23/12/2019 |
Locations
Countries of recruitment
- Spain
Study participating centre
Advanced Clinical Simulation Center
Avda. Ramón y Cajal, 7
Valladolid
47005
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/03/2025 | 24/03/2025 | Yes | No |
Editorial Notes
24/03/2025: Publication reference added.
03/01/2020: Internal review.
02/01/2020: Trial's existence confirmed by Comité de Ética de la Investigación con medicamentos (CEIm) Area de Salud de Valladolid Oeste [Drug Research Ethics Committee of West Valladolid Health Region]
