Serious GamesNCT05637749
Flow Regulation in Medical Serious Games
A study testing Medical serious game intervention (educational) in people with Serious Games and Psychological Flow, run by Nanyang Technological University at 1 site in Singapore.
Trial summary
The goal of this study is to access the effect of facilitation on amount of psychological Flow generated in medical students playing a medical serious game. Students will be randomly assigned to play a serious game designed to revise diabetes management knowledge with and without a facilitator and the amount of Flow… Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Serious Games, Psychological Flow, Diabetes Mellitus
- What is being tested?
- Medical serious game intervention (educational)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Feb 2023to 6 Sep 2023
- 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects enrolled in M1 through to M5 of the MBBS program under LKCMedicine.
Who cannot join
- Students who have previously partaken in play testing of the intervention
- Students not enrolled in the Bachelor of Medicine and Bachelor of Surgery (MBBS) program under LKCMedicine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms of Flow Regulation in a Novel Digital Serious Game for Rehearsing Complex Medical Subjects
The goal of this study is to access the effect of facilitation on amount of psychological Flow generated in medical students playing a medical serious game. Students will be randomly assigned to play a serious game designed to revise diabetes management knowledge with and without a facilitator and the amount of Flow experienced compared. They will then be invited to partake in a focus group discussion to elicit insights into the mechanism of action governing facilitator-induced Flow
Read the detailed description
The prevalence of diabetes and their complications is set to increase in line with Singapore's aging population, and the increasing complexities of medicine have left healthcare professionals beyond endocrinology reduced time or interest to seek out clinical sources of rehearsal. Despite having been taught diabetes management, knowledge not practiced fades over time, and delays or errors wrought by uncertainties may result in preventable loss of life or limb. Additionally, while many digital products exist to assist diabetes patients and caregivers, few cater to busy healthcare professionals and fewer account for differing levels of competency amongst them.
To address these needs, the study proposes the development and feasibility testing of a simulation-based diabetes management digital game incorporating a feature allowing for a human facilitator to moderate and personalise the rehearsal activity with consideration for a learner's strength and weaknesses.
The proposed mixed methods study thus presents the following aims:
Feasibility examination of the developed game intervention as an appropriate rehearsal tool for medical students
Comparing the degree of Flow (a state of total cognitive immersion in an activity) experienced by students who play the intervention with and without a facilitator
Generation of preliminary training data to guide either the development of more refined interventions wherein formal training data may be collected, or the direct training of a machine intelligence to assume the place of the human facilitator Map, where possible, the structure of the mechanism of action governing the interaction of facilitation and Flow in rehearsal-based digital serious games The study aims to accomplish these aims by first conducting a two-arm superiority randomised control trial (RCT) comparing the Flow Short Scale (7-point Likert scale survey measuring Flow) scores and in-game game analytics, such as number of correct decisions and reaction times, between students assigned to the facilitated and non-facilitated conditions.
Following this, students assigned to both conditions will be either be invited to partake in a focus group discussion, or given an open-ended questionnaire structured to solicit their attitudes, perceptions, and opinions of the game that may reveal insights into the mechanism of action governing facilitator-induced Flow.
- Conditions
- Serious Games, Psychological Flow, Diabetes Mellitus
- Being tested
- Medical serious game intervention (educational)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical serious game intervention (educational)Other
Medical serious game designed to facilitate the rehearsal of diabetes management knowledge. Players are presented with a colony of individuals, all of whom have some form of diabetes, and are tasked to manage food, insulin, and medication intake throughout the day. The intervention may be played with a facilitator.
Medical serious game intervention (educational)Other
Medical serious game designed to facilitate the rehearsal of diabetes management knowledge. Players are presented with a colony of individuals, all of whom have some form of diabetes, and are tasked to manage food, insulin, and medication intake throughout the day. The intervention may be played alone.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Serious game intervention to be played as is, without facilitation. Receives: Other: Medical serious game intervention (educational) |
| Intervention | Active comparator | Serious game intervention to be played with facilitator present in game environment. Receives: Other: Medical serious game intervention (educational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Short Scale (FSS) scores
The FSS comprises 13 items on a 7-point Likert scale ranging from 1 ("not at all) to 7 ("very much"). It demonstrates good construct validity, psychometric properties, and a stable three-factor structure comprising fluency of performance, absorption by activity, and perceived importance or outcome importance of said activity.
Measured: Immediately upon conclusion of the game activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Feb 2023
- Primary completion6 Sep 2023
- Study completion6 Sep 2023
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 Serious GamesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sreenivasulu Reddy Mogali, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637749
- Sponsor's protocol ID
- IRB-2022-739
- Status last verified
- Mar 2024
- First submitted
- 24 Nov 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan JW, Tan G, Lian X, Chong DKS, Rajalingam P, Dalan R, Mogali SR. Impact of Facilitation on Cognitive Flow in a Novel Diabetes Management Rehearsal Game for Health Professions Education: Mixed Methods, Open-Label, Superiority Randomized Controlled Trial. JMIR Serious Games. 2024 Jul 17;12:e54703. doi: 10.2196/54703.
PubMed 38900700
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Flow Regulation in a Novel Digital Serious Game for Rehearsing Complex Medical Subjects
- ClinicalTrials.gov ID
- NCT05637749
- Acronym / sponsor ID
- IRB-2022-739
- Conditions
- Serious Games, Psychological Flow, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 5 Dec 2022 (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.
The goal of this study is to access the effect of facilitation on amount of psychological Flow generated in medical students playing a medical serious game. Students will be randomly assigned to play a serious game designed to revise diabetes management knowledge with and without a facilitator and the amount of Flow experienced compared. They will then be invited to partake in a focus group discussion to elicit insights into the mechanism of action governing facilitator-induced Flow
Detailed description
The prevalence of diabetes and their complications is set to increase in line with Singapore's aging population, and the increasing complexities of medicine have left healthcare professionals beyond endocrinology reduced time or interest to seek out clinical sources of rehearsal. Despite having been taught diabetes management, knowledge not practiced fades over time, and delays or errors wrought by uncertainties may result in preventable loss of life or limb. Additionally, while many digital products exist to assist diabetes patients and caregivers, few cater to busy healthcare professionals and fewer account for differing levels of competency amongst them.
To address these needs, the study proposes the development and feasibility testing of a simulation-based diabetes management digital game incorporating a feature allowing for a human facilitator to moderate and personalise the rehearsal activity with consideration for a learner's strength and weaknesses.
The proposed mixed methods study thus presents the following aims:
Feasibility examination of the developed game intervention as an appropriate rehearsal tool for medical students
Comparing the degree of Flow (a state of total cognitive immersion in an activity) experienced by students who play the intervention with and without a facilitator
Generation of preliminary training data to guide either the development of more refined interventions wherein formal training data may be collected, or the direct training of a machine intelligence to assume the place of the human facilitator Map, where possible, the structure of the mechanism of action governing the interaction of facilitation and Flow in rehearsal-based digital serious games The study aims to accomplish these aims by first conducting a two-arm superiority randomised control trial (RCT) comparing the Flow Short Scale (7-point Likert scale survey measuring Flow) scores and in-game game analytics, such as number of correct decisions and reaction times, between students assigned to the facilitated and non-facilitated conditions.
Following this, students assigned to both conditions will be either be invited to partake in a focus group discussion, or given an open-ended questionnaire structured to solicit their attitudes, perceptions, and opinions of the game that may reveal insights into the mechanism of action governing facilitator-induced Flow.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: Medical serious game intervention (educational)Serious game intervention to be played as is, without facilitation. |
| Intervention | Active comparator | Other: Medical serious game intervention (educational)Serious game intervention to be played with facilitator present in game environment. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects enrolled in M1 through to M5 of the MBBS program under LKCMedicine.
Key exclusion criteria (2 listed)
- Students who have previously partaken in play testing of the intervention
- Students not enrolled in the Bachelor of Medicine and Bachelor of Surgery (MBBS) program under LKCMedicine
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 |
|---|---|---|
| Medical serious game intervention (educational)Medical serious game designed to facilitate the rehearsal of diabetes management knowledge. Players are presented with a colony of individuals, all of whom have some form of diabetes, and are tasked to manage food, insulin, and medication intake throughout the day. The intervention may be played with a facilitator. | Other | Intervention |
| Medical serious game intervention (educational)Medical serious game designed to facilitate the rehearsal of diabetes management knowledge. Players are presented with a colony of individuals, all of whom have some form of diabetes, and are tasked to manage food, insulin, and medication intake throughout the day. The intervention may be played alone. | Other | Control |
Primary outcome
Flow Short Scale (FSS) scores
Time frame: Immediately upon conclusion of the game activity
The FSS comprises 13 items on a 7-point Likert scale ranging from 1 ("not at all) to 7 ("very much"). It demonstrates good construct validity, psychometric properties, and a stable three-factor structure comprising fluency of performance, absorption by activity, and perceived importance or outcome importance of said activity.
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 21 Mar 2024.
- Derived from this study: PubMed 38900700Tan JW, Tan G, Lian X, Chong DKS, Rajalingam P, Dalan R, Mogali SR. Impact of Facilitation on Cognitive Flow in a Novel Diabetes Management Rehearsal Game for Health Professions Education: Mixed Methods, Open-Label, Superiority Randomized Controlled Trial. JMIR Serious Games. 2024 Jul 17;12:e54703. doi: 10.2196/54703.
- Individual participant dataSharing planned: No
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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 Medical serious game intervention (educational) in people with Serious Games and Psychological Flow, run by Nanyang Technological University at 1 site in Singapore.
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 2 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 21 Mar 2024. 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 Singapore. 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?
Flow Short Scale (FSS) scores (time frame: Immediately upon conclusion of the game activity). 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 NCT05637749, 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 21 Mar 2024.