- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05637749
Flow Regulation in Medical Serious Games
Mechanisms of Flow Regulation in a Novel Digital Serious Game for Rehearsing Complex Medical Subjects
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sreenivasulu Reddy Mogali, PhD
- Phone Number: +65 65923114
- Email: sreenivasulu.reddy@ntu.edu.sg
Study Contact Backup
- Name: Jun Wen Tan, BPsy
- Phone Number: +65 65923114
- Email: junwen001@e.ntu.edu.sg
Study Locations
-
-
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Singapore, Singapore, 308232
- Lee Kong Chian School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects enrolled in M1 through to M5 of the MBBS program under LKCMedicine.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control
Serious game intervention to be played as is, without facilitation.
|
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 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.
|
Active Comparator: Intervention
Serious game intervention to be played with facilitator present in game environment.
|
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Immediately upon conclusion of the game activity
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB-2022-739
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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