NCT04428892

Brief 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. this protocol allows us to compare two strategies with simulation for to promote clinical decisions in physiotherapy practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 2, 2020

Last Update Submit

June 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 Month

Study Arms (2)

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.

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

Behavioral: Pedagogyc Strategy

Interventions

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.

Clinical SimulationConventional Pedagogical strategy

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Physiotherapy students in five-semester from Universidad de La Sabana and Universidad de Boyacá

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolina Sandoval

Tunja, Colombia

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 11, 2020

Study Start

March 1, 2019

Primary Completion

May 20, 2019

Study Completion

December 20, 2019

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations