An interventional study of A relaxing VR environment and A stress-inducing VR game in Post Prandial Blood Glucose and Feasibility Pilot Study, sponsored by University of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Manitoba · Not applicable, Interventional, and Other
This randomized cross-over pilot clinical trial aims to evaluate the feasibility and effect of a relaxing virtual reality (VR) experience on glucose response after white bread consumption, compared to a stress-inducing VR, a VR clinical room, and a real clinical room, in healthy adults. Participants will use a head-mounted display to experience either one of the VR environments, or they will simply sit in an actual clinical room for 15 minutes. After this pre-meal condition, participants will consume 66 grams of white bread within 10 minutes, accompanied by 250 mL of water. They will then continue their assigned pre-meal condition for one hour, followed by an additional hour of sitting in the lab for further assessments.
The feasibility of the study will be assessed by calculating: 1) Screening to randomization ratio, 2) Recruitment rate of participants per week, 3) Retention rate, 4) Data Completeness of Finger-Prick Glucose Measurements, and 5) VR intervention tolerability measured by Simulator Sickness Questionnaire (SSQ) score. Postprandial glucose response, stress levels, heart rate, and skin conductance will be assessed at baseline (15 minutes before white bread consumption), immediately before consumption (time 0), and at 15, 30, 45, 60, 90, and 120 minutes post-consumption. Palatability will be evaluated immediately after the meal consumption. Motivation to eat will also be assessed at 0, 15, 30, 45, 60, 90, and 120 minutes. Sense of presence will be measured immediately after VR exposure. Additionally, simulator sickness will be assessed at the beginning of the study and after VR exposure.
The results will help us better understand the potential feasibility and benefits of using relaxing VR for postprandial glucose management. These findings will also provide evidence to optimize the design of future definitive randomized clinical trials and enhance the development of VR interventions.
Participants must meet all of the following criteria to be eligible for the study:
Participants will be excluded if they meet any of the following conditions:
Device: A relaxing VR environment
Device: A stress-inducing VR game
Device: A VR clinical room
Other: A non-VR clinical room
The TRIPP application, a relaxing VR environment that provides an immersive mindfulness.
"Affected: The Manor Complete Edition," which is a horror-themed VR game involving a walk-through of a haunted house designed to evoke stress (Positive control).
A VR clinical room resembling the real clinical room as a sham control
A non-VR clinical room (real clinical environment).
The feasibility of VR interventions for blood glucose response to food
The feasibility of VR interventions for blood glucose response to food will be evaluated using a predefined red-yellow-green progression framework. This framework assesses five key feasibility metrics related to the study: screening to randomization ratio, recruitment rate, retention, data completeness of finger-prick glucose measurements, and VR intervention tolerability. Each metric will be judged against the three zones: green indicates feasibility, yellow suggests that modifications are needed, and red signifies that the trial is not feasible for a larger study in its current design.
Time frame: Feasibility will be measured through study completion, an average of 4 weeks.
Postprandial glucose response
We will use a calibrated finger-prick device to measure blood glucose concentration.
Time frame: Capillary blood glucose will be measured at baseline and periprocedural.
Stress levels
Stress level will be assessed using the Visual Analog Scale (VAS), a 10-cm line on which 0 indicates the lowest level of stress and 10 indicates the highest.
Time frame: Visual analog scale (VAS) measuring self-reported stress levels will be completed at the baseline and periprocedural.
Skin conductance
MINDFILD@ eSence Skin Response Units will be used to evaluate skin conductance
Time frame: Skin conductance will be measured at baseline and periprocedural.
Heart rate
MINDFILD@ eSense PULSE-Heart Rate Variability sensors will be used for heart rate.
Time frame: Heart rate will be measured at baseline and periprocedural.
Participants' sense of presence in VR
Participants' sense of presence in VR will be evaluated using the iGroup Presence Questionnaire, a 14-item instrument with a 7-point scale ranging from -3 to +3, where -3 indicates strong disagreement and +3 indicates strong agreement with the statement
Time frame: It will be measured immediately after exposure to VR environments
Simulator sickness
Simulator sickness will be assessed using the Simulator Sickness Questionnaire (SSQ), which includes sixteen items representing the severity of symptoms that may occur due to exposure to a VR environment, rated from none to severe.
Time frame: It will be measured at the beginning and immediately after VR exposure.
Palatability
To measure palatability, a 3-item, self-reported questionnaire will be used. Each item can be answered with a Visual Analog Scale (VAS), a 10 cm line indicating the extent of the participant's feeling, while 0 represents the lowest possible rating and 10 represents the highest.
Time frame: The Visual Analog Scale (VAS) measuring self-reported palatability will be completed right after the consumption of the white bread meal.
Appetite
Appetite will be assessed using the Visual Analog Scale (VAS), a five-item questionnaire in which each item is represented by a 10 cm line indicating the extent of the participant's feeling. On each line, 0 represents the lowest possible rating and 10 represents the highest.
Time frame: The visual analog scale (VAS) measuring self-reported appetite will be completed periprocedurally
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University of Manitoba