HealthyNCT06308900
Non-technical Skills of Clinical Simulation in Physiotherapy Students
A study testing Clinical simulation in people with Healthy, run by University of Valencia at 1 site in Spain.
Trial summary
Clinical simulation has gained great importance in recent times in health sciences. Since it is a pedagogical strategy that is being used more and more in health degrees and is very useful for the acquisition of both technical and non-technical skills. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Clinical simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Second year students of the Physiotherapy Degree
- They do not have clinical experience with real patients.
Who cannot join
- Not wanting to sign to participate in the study.
- Not signing the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Non-technical Skills of Clinical Simulation in Physiotherapy Students and Analysis of the Experience
Clinical simulation has gained great importance in recent times in health sciences. Since it is a pedagogical strategy that is being used more and more in health degrees and is very useful for the acquisition of both technical and non-technical skills.
However, if we focus on physiotherapy, the use of clinical simulation is a very new field and therefore requires great research. The investigators still do not have the consistency or experience as in other health branches such as medicine or nursing, in which they have been using simulators for years for the learning of all their students.
For all this, and for the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely abolished, the need for our research is justified, which will allow the acquisition of non-technical skills among novice students. in physiotherapy, without the need for contact with real patients.
- Conditions
- Healthy
- Being tested
- Clinical simulation
- Keywords
- Physiotherapy, Students, Learning methodology, Clinical simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical simulationOther
Carrying out a total of 9 clinical simulation in three days, one day a week, where the student resolves a situation by taking on the role of a physiotherapist with a simulated patient.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Physitherapy students Receives: Other: Clinical simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ottawa Scale
Modified Ottawa Scale for the acquisition of non-technical skills, validated in Spanish (https://doi.org/10.1016/j.redar.2021.02.009).
Each of the items evaluated must be classified from 'strongly disagree', whose value is zero, to 'strongly agree', whose value is 7.
The scale will be passed after each of the 9 simulations, which will be carried out 3 on the same day, for three weeks.
Measured: 1 week, 2, week, 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start26 Feb 2024
- Primary completion31 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hernández-Guillén, University of Valencia
- Investigators
- David Hernández-Guillén, Study director, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308900
- Sponsor's protocol ID
- CL_SIMULATION_01
- Status last verified
- May 2024
- First submitted
- 5 Mar 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-technical Skills of Clinical Simulation in Physiotherapy Students and Analysis of the Experience
- ClinicalTrials.gov ID
- NCT06308900
- Acronym / sponsor ID
- CL_SIMULATION_01
- Conditions
- Healthy
- Keywords
- Physiotherapy, Students, Learning methodology, Clinical simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical simulation has gained great importance in recent times in health sciences. Since it is a pedagogical strategy that is being used more and more in health degrees and is very useful for the acquisition of both technical and non-technical skills.
However, if we focus on physiotherapy, the use of clinical simulation is a very new field and therefore requires great research. The investigators still do not have the consistency or experience as in other health branches such as medicine or nursing, in which they have been using simulators for years for the learning of all their students.
For all this, and for the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely abolished, the need for our research is justified, which will allow the acquisition of non-technical skills among novice students. in physiotherapy, without the need for contact with real patients.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Clinical simulationPhysitherapy students |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Second year students of the Physiotherapy Degree
- They do not have clinical experience with real patients.
Key exclusion criteria (2 listed)
- Not wanting to sign to participate in the study.
- Not signing the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical simulationCarrying out a total of 9 clinical simulation in three days, one day a week, where the student resolves a situation by taking on the role of a physiotherapist with a simulated patient. | Other | Experimental |
Primary outcome
Ottawa Scale
Time frame: 1 week, 2, week, 3 week
Modified Ottawa Scale for the acquisition of non-technical skills, validated in Spanish (https://doi.org/10.1016/j.redar.2021.02.009). Each of the items evaluated must be classified from 'strongly disagree', whose value is zero, to 'strongly agree', whose value is 7. The scale will be passed after each of the 9 simulations, which will be carried out 3 on the same day, for three weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hernández-Guillén study director
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical simulation in people with Healthy, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ottawa Scale (time frame: 1 week, 2, week, 3 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.