Pre and Post Simulation Session Self-directed Learning TimeNCT04040556
Enhancing Student Learning by Simulation
An observational study of Pre and Post Simulation Session Self-directed Learning Time, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
As the standard of best practice, care of complicated or difficult patient needs not only knowledge but also including skills and clinical thinking in many aspects. Simulation is now accepted as the way of teaching for adult learners. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pre and Post Simulation Session Self-directed Learning Time
- What is being tested?
- Simulation class
- How many people
- 22 participants
- Where
- 1 siteThailand
- Study dates
- 9 Nov 2017to 1 Apr 2018
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: - Anesthesia residences who are currently studying in the department of Anesthesia
Who may be able to join
- Anesthesia residences who are currently studying in the department of Anesthesia
Who cannot join
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
As the standard of best practice, care of complicated or difficult patient needs not only knowledge but also including skills and clinical thinking in many aspects.
Simulation is now accepted as the way of teaching for adult learners. This learning method can help students to apply their knowledge, practical skills and non-technical skills. A systematic review study showed that self-directed learning (SDL) in health professions education is associated with moderate improvement in the knowledge domain. SDL also help the learners to improve self-efficacy and the learning outcomes in complicated tasks.In this study, the investigators wanted to evaluate that simulation can enhance student to do SDL in the both pre and post session period.
Read the detailed description
After approval from the instution's Ethics Committee, a prospective cohort study was conducted between November 2017 to March 2018. Twenty-five anesthesia residents were participated in this study. Students were noticed about the simulation classes which are emergencies in pediatric anesthesia and complications at one-month prior the day of practice. The list of standard references was given. On the day of study, at the institute's simulation center, students were voluntarily separated into two groups, directed- learner and observer. Post class debriefing sessions were done as routine activities. After the class, the investigator invited the students to be enrolled in this study by using the flyers. Following the consent process, three consecutive questionnaires (day 0 ,30, 90) were sent to the subjects. The data analysis will be done by using R program. The statistically significance in this study was classified at p <0.05.
- Being tested
- Simulation class
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation classOther
Also called Simulation session
Pediatric anesthesia simulation class for anesthesia residences
| Study group | Role | What they receive |
|---|---|---|
| anesthesia residence | anesthesia residences who currently study in the department of Anesthesia and voluntarily enrolled into the study Receives: Other: Simulation class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-class Self-directed learning time
Time spent for studying by the student, themselves, prior the simulation class
Measured: 1 month before class
Post-class Self-directed learning time
Time spent for studying by the student, themselves, after the simulation class
Measured: upto 3 months after class
Secondary outcomes (2)
Knowledge retention
The percentage of knowledge (in pediatric anesthesia topic) retain after class
Measured: upto 3 months after class
Level of self-confidence to treat the real patient
Level of self-confidence to treat the real patient after class
Measured: upto 3 months after class
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start9 Nov 2017
- Primary completion9 Mar 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre and Post Simulation Session Self-directed Learning TimeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngamjit Pattaravit, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040556
- Sponsor's protocol ID
- Simulation SDL
- Status last verified
- Jul 2019
- First submitted
- 30 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Student Learning by Simulation
- ClinicalTrials.gov ID
- NCT04040556
- Acronym / sponsor ID
- Simulation SDL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 31 Jul 2019 (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.
As the standard of best practice, care of complicated or difficult patient needs not only knowledge but also including skills and clinical thinking in many aspects.
Simulation is now accepted as the way of teaching for adult learners. This learning method can help students to apply their knowledge, practical skills and non-technical skills. A systematic review study showed that self-directed learning (SDL) in health professions education is associated with moderate improvement in the knowledge domain. SDL also help the learners to improve self-efficacy and the learning outcomes in complicated tasks.In this study, the investigators wanted to evaluate that simulation can enhance student to do SDL in the both pre and post session period.
Detailed description
After approval from the instution's Ethics Committee, a prospective cohort study was conducted between November 2017 to March 2018. Twenty-five anesthesia residents were participated in this study. Students were noticed about the simulation classes which are emergencies in pediatric anesthesia and complications at one-month prior the day of practice. The list of standard references was given. On the day of study, at the institute's simulation center, students were voluntarily separated into two groups, directed- learner and observer. Post class debriefing sessions were done as routine activities. After the class, the investigator invited the students to be enrolled in this study by using the flyers. Following the consent process, three consecutive questionnaires (day 0 ,30, 90) were sent to the subjects. The data analysis will be done by using R program. The statistically significance in this study was classified at p <0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anesthesia residence | – | Other: Simulation classanesthesia residences who currently study in the department of Anesthesia and voluntarily enrolled into the study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - Anesthesia residences who are currently studying in the department of Anesthesia
Key inclusion criteria (1 listed)
- Anesthesia residences who are currently studying in the department of Anesthesia
Key exclusion criteria (1 listed)
- Refuse to participate
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 |
|---|---|---|
| Simulation classAlso: Simulation sessionPediatric anesthesia simulation class for anesthesia residences | Other | anesthesia residence |
Primary outcome
Pre-class Self-directed learning time
Time frame: 1 month before class
Time spent for studying by the student, themselves, prior the simulation class
Post-class Self-directed learning time
Time frame: upto 3 months after class
Time spent for studying by the student, themselves, after the simulation class
2 secondary outcomes
Knowledge retention
Time frame: upto 3 months after class
Level of self-confidence to treat the real patient
Time frame: upto 3 months after class
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 Aug 2019.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Pre and Post Simulation Session Self-directed Learning Time, run by Prince of Songkla University at 1 site in Thailand.
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 1 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 Aug 2019. 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 Thailand. 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?
Pre-class Self-directed learning time (time frame: 1 month before class). The study lists 2 primary outcomes in all. 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 Aug 2019.