- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04428892
Simulation in Physical Therapy Students
June 9, 2020 updated by: Universidad de la Sabana
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tunja, Colombia
- Carolina Sandoval
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 19 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Physiotherapy students in five-semester from Universidad de La Sabana and Universidad de Boyacá
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Clinical Simulation
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.
|
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.
|
|
Active Comparator: Conventional Pedagogical strategy
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
May 20, 2019
Study Completion (Actual)
December 20, 2019
Study Registration Dates
First Submitted
June 2, 2020
First Submitted That Met QC Criteria
June 9, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 9, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- ENF-19-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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