Simulation TrainingNCT04428892
Simulation in Physical Therapy Students
A study testing Pedagogyc Strategy in people with Simulation Training, run by Universidad de la Sabana at 1 site in Colombia.
Trial summary
This randomized trial included physiotherapy students, randomized in two groups, experimental one included simulation for developed competencies related to clinical reasoning in physiotherapy interventions for people with low back pain. The second group developed role-playing. Read more about this study
- Who is it for?
- Ages 18 to 23 years
- Conditions the study is for
- Simulation Training
- What is being tested?
- Pedagogyc Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- 1 Mar 2019to 20 Dec 2019
- 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 23 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physiotherapy students in five-semester from Universidad de La Sabana and Universidad de Boyacá
Who cannot join
- under-age subjects
- those who had been internally or externally transferred from another academic program in health,
- exchange students
- those repeating
- with prior experiences in simulated practice in other assignments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CLINICAL SIMULATION IN PHYSIOTHERAPY STUDENTS IN CLINICAL COMPETENCE FOR INTERACT WITH PEOPLE WITH LOW BACK PAIN. COLOMBIA
This randomized trial included physiotherapy students, randomized in two groups, experimental one included simulation for developed competencies related to clinical reasoning in physiotherapy interventions for people with low back pain. The second group developed role-playing. this protocol allows us to compare two strategies with simulation for to promote clinical decisions in physiotherapy practice.
Read the detailed description
Low back pain (LBP) is symptomatology with a high global prevalence; health professionals, including physiotherapists, must have the skills to create professional interaction plans that permit a better quality of life for consultants. Clinical simulation can be a pedagogic setting that facilitates students with adequate training to acquire skills that improve professional reasoning in this clinical situation. The objective of this study was to compare the effects of clinical simulation with a simulated patient (SP) versus simulation with role-playing (RP) in physiotherapy students for decision-making in clinical skills while caring for a person with LBP. Methods. An experimental study, with 42 participants from two Colombian universities, randomized into two groups (SP n = 21, RP n = 21). The clinical skill was evaluated during the interaction with a person with LBP for which the Objective Structured Clinical Examination (OSCE-ML) was validated for individuals with low back pain; thereafter, a pedagogical method was conducted that included clinical simulation and, finally, the OSCE-ML was applied again to compare both groups.
- Conditions
- Simulation Training
- Being tested
- Pedagogyc Strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedagogyc StrategyBehavioural
Simulation can be used as a pedagogic tool that provides students with significant learning regarding decision-making in interacting with people, in this case patients with LBP. It is a potential strategy for developing diverse skills focused on the safety of the patient and the therapist.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Simulation | Experimental | The group denominated SP received a teaching strategy based on a class session with simulated practice for decision-making in clinical skills when caring for a person with LBP. Each session lasted approximately 120 minutes, and the clinical case used for the SP sessions was subjected to face validity with experts in the area of study. Receives: Behavioral: Pedagogyc Strategy |
| Conventional Pedagogical strategy | Active comparator | received a class session based on a "role playing" simulation strategy, structured for the same purpose established in the SP group. This session lasted approximately 120 minutes, and the learning environment was the classroom in which students assumed different roles to act out; some of them acted as people with LBP and others as physiotherapists Receives: Behavioral: Pedagogyc Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical reasoning
The Objetive structured Clinical Evaluation (OSCE) was designed and validated, with the proposal to asses the physiotherapeutic clinical reasoning in Low Back Pain people, The OCSE have included 7 stations for assesing the clinical reasoning students.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Mar 2019
- Primary completion20 May 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Simulation TrainingStudies 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Collaborators
- Facultad Ciencias de La Salud Universidad de Boyaca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428892
- Sponsor's protocol ID
- ENF-19-2017
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sandoval-Cuellar C, Alfonso-Mora ML, Castellanos-Garrido AL, Del Pilar Villarraga-Nieto A, Goyeneche-Ortegon RL, Acosta-Otalora ML, Del Pilar Castellanos-Vega R, Cobo-Mejia EA. Simulation in physiotherapy students for clinical decisions during interaction with people with low back pain: randomised controlled trial. BMC Med Educ. 2021 Jul 9;21(1):375. doi: 10.1186/s12909-021-02812-7.
PubMed 34243767
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL SIMULATION IN PHYSIOTHERAPY STUDENTS IN CLINICAL COMPETENCE FOR INTERACT WITH PEOPLE WITH LOW BACK PAIN. COLOMBIA
- ClinicalTrials.gov ID
- NCT04428892
- Acronym / sponsor ID
- ENF-19-2017
- Conditions
- Simulation Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Collaborators
- Facultad Ciencias de La Salud Universidad de Boyaca
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 11 Jun 2020 (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.
This randomized trial included physiotherapy students, randomized in two groups, experimental one included simulation for developed competencies related to clinical reasoning in physiotherapy interventions for people with low back pain. The second group developed role-playing. this protocol allows us to compare two strategies with simulation for to promote clinical decisions in physiotherapy practice.
Detailed description
Low back pain (LBP) is symptomatology with a high global prevalence; health professionals, including physiotherapists, must have the skills to create professional interaction plans that permit a better quality of life for consultants. Clinical simulation can be a pedagogic setting that facilitates students with adequate training to acquire skills that improve professional reasoning in this clinical situation. The objective of this study was to compare the effects of clinical simulation with a simulated patient (SP) versus simulation with role-playing (RP) in physiotherapy students for decision-making in clinical skills while caring for a person with LBP. Methods. An experimental study, with 42 participants from two Colombian universities, randomized into two groups (SP n = 21, RP n = 21). The clinical skill was evaluated during the interaction with a person with LBP for which the Objective Structured Clinical Examination (OSCE-ML) was validated for individuals with low back pain; thereafter, a pedagogical method was conducted that included clinical simulation and, finally, the OSCE-ML was applied again to compare both groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Simulation | Experimental | Behavioral: Pedagogyc StrategyThe group denominated SP received a teaching strategy based on a class session with simulated practice for decision-making in clinical skills when caring for a person with LBP. Each session lasted approximately 120 minutes, and the clinical case used for the SP sessions was subjected to face validity with experts in the area of study. |
| Conventional Pedagogical strategy | Active comparator | Behavioral: Pedagogyc Strategyreceived a class session based on a "role playing" simulation strategy, structured for the same purpose established in the SP group. This session lasted approximately 120 minutes, and the learning environment was the classroom in which students assumed different roles to act out; some of them acted as people with LBP and others as physiotherapists |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physiotherapy students in five-semester from Universidad de La Sabana and Universidad de Boyacá
Key exclusion criteria (5 listed)
- under-age subjects
- those who had been internally or externally transferred from another academic program in health,
- exchange students
- those repeating
- with prior experiences in simulated practice in other assignments
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 |
|---|---|---|
| Pedagogyc StrategySimulation can be used as a pedagogic tool that provides students with significant learning regarding decision-making in interacting with people, in this case patients with LBP. It is a potential strategy for developing diverse skills focused on the safety of the patient and the therapist. | Behavioural | Clinical Simulation, Conventional Pedagogical strategy |
Primary outcome
clinical reasoning
Time frame: 1 Month
The Objetive structured Clinical Evaluation (OSCE) was designed and validated, with the proposal to asses the physiotherapeutic clinical reasoning in Low Back Pain people, The OCSE have included 7 stations for assesing the clinical reasoning students.
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 11 Jun 2020.
- Derived from this study: PubMed 34243767Sandoval-Cuellar C, Alfonso-Mora ML, Castellanos-Garrido AL, Del Pilar Villarraga-Nieto A, Goyeneche-Ortegon RL, Acosta-Otalora ML, Del Pilar Castellanos-Vega R, Cobo-Mejia EA. Simulation in physiotherapy students for clinical decisions during interaction with people with low back pain: randomised controlled trial. BMC Med Educ. 2021 Jul 9;21(1):375. doi: 10.1186/s12909-021-02812-7.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedagogyc Strategy in people with Simulation Training, run by Universidad de la Sabana at 1 site in Colombia.
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 1 inclusion and 5 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 11 Jun 2020. 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 Colombia. 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?
clinical reasoning (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04428892, which also lists 1 linked publication.
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 11 Jun 2020.