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Educational ProblemsNCT04692142

A Cross-over Randomised Trial Comparing Two Teaching Methods

A study testing Flipped classroom teaching method in people with Educational Problems, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study aim to test the null hypothesis which states that there are no significant differences in knowledge retention and exam performance of dental undergraduate students in a Saudi Dental School using two different asynchronous teaching methods . Read more about this study

Who is it for?
Ages 22 to 28 years, men onlyHealthy volunteers can take part
Conditions the study is for
Educational Problems
What is being tested?
Flipped classroom teaching method
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSaudi Arabia
Study dates
30 Aug 2020to 30 Jan 2022
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 22 to 28 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Fourth-year undergraduate students enrolled in the course, in a Saudi Dental college.

Who cannot join

  • Students who are enrolled in the course for a second time

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Prince Sattam Bin Abdulaziz University

    Al Kharjah

Other trials in Saudi Arabia

About this study

Official title: Comparison Between Different Asynchronous Teaching Methods in an Undergraduate Orthodontic Course: A Crossover Randomised Trial

The aim of the study aim to test the null hypothesis which states that there are no significant differences in knowledge retention and exam performance of dental undergraduate students in a Saudi Dental School using two different asynchronous teaching methods . The secondary aim is to analyse students' perceptions to the two teaching methods.

Read the detailed description

Design: The trial was designed as a crossover clustered randomized trial whereby each group/ cluster acted as their control for their learning performance and perception.

Setting: College of Dentistry, Princes Sattam Bin Abdulaziz University, Riyadh, Saudi Arabia.

Consents: The ethical approval was obtained from the Scientific Research Unit at the College of Dentistry, Prince Sattam Bin Abdulaziz University, Alkharj, Riyadh (ethical approval PSAU2020030). Written consent was obtained from students before commencing the trial.

Participants: Fourth-year undergraduate dental students enrolled in the preclinical orthodontic course at Prince Sattam University were invited to participate in the study. Students who were registered in the course for the second time were excluded to lessen the bias associated with previous experience of orthodontic teaching. The sample size was based on the total number of students registered in the course at the time of the study.

Randomization: Computer-generated randomization was performed to allocate participants to one of two groups. The sequence of random allocation was concealed from researchers who analyzed the results. Participants in the control group were taught through the virtual traditional learning method (VTL) using live-video streaming, while participants in the intervention group were taught through the virtual flipped learning method (VFL). VTL group included 16 students, while the VFL group included 17 students. We use the term control group to refer to students who studied using the VTL format method across both periods. We also use the term intervention group to refer to students who studied using VFL format across both periods.

Intervention: 4 lectures were delivered asynchronously using two different teaching methods as mentioned above. Participants in VFL had monitored remote access to the recorded lectures for one week, followed by 4 additional small group online discussion sessions. The students in both groups remotely attended all pre-recorded and live-video virtual lectures.

Intervention implementation rounds The intervention was implemented in 3 consecutive weeks. The first lecture (L1: Adult Orthodontics) was taught in the first week. Before L1, all students were asked to complete a set of multiple-choice questions (MCQs) formative exam (i.e., pre-test). Following the pre-test, the lecture was delivered to participants of the VTL group using a passive online teaching format (live-video streaming). L1 was also recorded after obtaining verbal consent from the attendees. After the lecture was completed, students were asked to re-take the same pre-test exam and complete a questionnaire regarding the VTL experience.

Within 24 hours following L1, participants of VFL had 7-day monitored remote access to the recorded lecture of L1, and they were taught using an active teaching model, referred to as the VFL model. Like the participants of the VTL group, participants of the VFL group were asked to complete the relevant pre-test.

At the expiry of remote access to the recorded lecture, participants from VFL were invited to attend post-lecture discussion sessions. To enhance the effectiveness of post-lecture discussion, participants were randomly divided into two smaller subgroups, and the same lecturer facilitated the discussions for each group separately. At the end of each discussion session, participants were asked to re-take the pre-test of L1 and a complete questionnaire regarding their VFL experience.

Following the small group's discussion session, participants of VFL were given a 30-minute break before the start of the second lecture related to the topic of Orthognathic Surgery (L2). However, the intervention was crossed over; hence, the cohort of VFL in week 1 acted as a control group while teaching L2 and vice versa. The same protocol of teaching models that were applied in week 1 was adopted.

Participants of both groups were taught by the same instructor using the same materials, irrespective of the teaching methods. The lectures were delivered using the same presentation platform (PowerPoint, Microsoft Corp, Redmond, WA) and the same virtual learning platform (Zoom live-streaming software - Zoom Video Communications, Inc, San Jose, California, Version 5.4.3). The duration of each lecture was 60 minutes, while the post-lecture discussion in the VFL design lasted 15 minutes. Learning outcomes were based on each lecture's learning objectives and outcomes that aligned with what is specified by the National Commission for Academic Accreditation and Assessment in Saudi Arabia.

Being tested
Flipped classroom teaching method
Keywords
Learning, Dental education, Teaching methods, Dental Students

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flipped classroom teaching methodOther

    Participants will have 7 -day monitored remote access to a recorded lecture about orthodontic topic. At the expiry of remote access to the recorded lecture, participants from FG will be invited to attend post-lecture discussion sessions. To enhance the effectiveness of flipped classroom teaching method, the cohort of FG will be randomly, using computer generated randomisation, subdivided to two smaller groups in which each group will be consisted of half of the FG cohort. The same lecturer will moderate the discussions for each group separately.

Study groups in NCT04692142
Study groupRoleWhat they receive
Passive onlineActive comparatorBefore L1, all students will be asked to complete a set of multiple-choice questions (MCQs), formative exam (i.e. pre-test). Following the test , the lecture will be delivered to the participants of PG using a passive online teaching format for 60 minutes (i.e., live-video streaming). After the lecture is completed, students will be asked to re-take the same pre-test exam and complete questionnaire regarding their experience with the teaching methods.
Receives: Other: Flipped classroom teaching method
Flipped classroomExperimentalParticipants of FG will have an access to a recorded lecture. and they will be taught using an active teaching model known as flipped classroom model. In this model, participants will have 7 -day monitored remote access to the recorded L1. Similar to PG, completing the online pre-test formative exam will be preliminary requirement to access the published recorded L1. At the expiry of remote access to the recorded lecture, participants from FG will be invited to attend post-lecture discussion sessions. To enhance the effectiveness of flipped classroom teaching method, the cohort of FG will be randomly, using computer generated randomisation, subdivided to two smaller groups in which each group will be consisted of half of the FG cohort. The same lecturer will moderate the discussions for each group separately. After the lecture is completed, students will be asked to re-take the same pre-test of L1 and complete questionnaire regarding their experience with the teaching methods.
Receives: Other: Flipped classroom teaching method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Formative exam

    Before each lecture, students will complete a set of multiple-choice questions (MCQs), formatively (i.e. pre-test). These questions will be related to the taught topics, and will be administered remotely using learning management system (Blackboard). After each lecture, students will be asked to re-take the same pre-test via Blackboard. This formative assessment test will measure students' learning gain. Two investigators will construct the pre-test questions to ensure its content validity and reliability. Content validity will be tested using test matrix and experts judgment. The reliability test will estimated using inter-rater reliability. A correlation of more than 0.7 will be considered acceptable.

    Measured: 7-days

Secondary outcomes (1)
  1. Perception to the two teaching methods.

    At the end of each lecture, students will be asked to answer a questionnaire regarding their experience with the teaching methods they have received. We will use the validated Web-Based Learning Environment Inventory (WELEI), developed by Chang and Fisher (2001). In addition to demographic section, the questionnaire consists of items that captures students' perceptions of web-based learning environments. Regarding the flipped classroom teaching method, we will include additional questions adapted from previous studies that examined students' perception of the flipped classroom (Johnson, 2013 and Butt, 2014). The questionnaire will be distributed online via SurveyMonkey (San Mateo, California, United States).

    Measured: 7-days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2020
  2. Study start30 Aug 2020
  3. Primary completion30 Dec 2021
  4. Study completion30 Jan 2022

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
The trial is designed as a cross-over clustered randomized trial (each group would be a cluster), so that each group will act as their own control for their learning performance and perception.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04692142
Sponsor's protocol ID
PSAU2020030
Status last verified
Apr 2022
First submitted
28 Dec 2020
Last updated
26 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared upon asking.

Publications

  • Alharbi F, Alwadei SH, Alwadei A, Asiri S, Alwadei F, Alqerban A, Almuzian M. Comparison between two asynchronous teaching methods in an undergraduate dental course: a pilot study. BMC Med Educ. 2022 Jun 23;22(1):488. doi: 10.1186/s12909-022-03557-7.

    PubMed 35739594

Questions about this trial

What is this clinical trial studying?

A study testing Flipped classroom teaching method in people with Educational Problems, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.

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 26 Apr 2022. 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 Saudi Arabia. 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?

Formative exam (time frame: 7-days). 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 NCT04692142, 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 26 Apr 2022.

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