Improving diabetes health symptoms by using a specialized VR gamification self-care method: A parallel-group randomized controlled trial

To develop a self-care system using gamification in a virtual reality (VR) environment and to evaluate its effects on diabetic patients’ metabolic symptoms, including fasting blood sugar (FBS), HbA1c, and BMI, as well as health-related behaviors, including physical activity and food intake.

A randomized clinical trial with four parallel groups (VR gamification, monitoring application, traditional counseling, and control group) was conducted. Sampling was performed using a closed, offline recruitment method at a clinic. The total sample size was 78 participants, of whom 60 were included in the final analysis. Randomization was performed using stratified block randomization based on age and gender.

Study setting: Children’s Medical Center in Tehran; Study population: children and adolescents aged 7–15 years with diabetes; Type of blinding: blinded data analyst; Blinding method: data analysis was conducted using coded labels for the groups so that the data analyst was unaware of the actual group identities.

Inclusion criteria: Formal diagnosis of Diabetes,; Age between 7 and 15 years; Willingness and ability to participate in a six-week VR-based program. Exclusion criteria: Physical or medical conditions that would prevent safe use of VR headsets (e.g., severe motion sickness or nausea).

VR gamified group: Participants received the VR gamified intervention specifically developed for this study. MySugr application group: Participants were instructed to use the MySugr diabetes self‑care. Traditional counseling group: Participants received routine face‑to‑face diabetes counseling, aligned with the clinic’s standard educational protocol. Control group: Participants received standard clinic care only, with no additional training.

Fasting blood glucose (FBS); Weekly sum of daily calculated physical activity (PA); Weekly average daily calculated food intake (daily calories); Weekly BMI; HbA1c

Randomization in this study was performed using computer‑generated stratified block randomization. After confirming eligibility and obtaining informed consent, participants were enrolled in the study. To ensure balance between study groups with respect to important baseline characteristics, randomization was stratified by age and gender. Within each stratum, participants were assigned to one of the four study groups (VR gamification intervention, MySugr application, traditional counseling, and control group) using random block allocation. The allocation sequence was generated using a computer‑based random number generator. Specifically, the website Randomization.com (https://www.randomization.com) was used to generate the block randomization sequence. The random allocation list was prepared before the start of participant recruitment by a technical assistant who was not involved in participant recruitment, intervention delivery, or outcome assessment. To ensure allocation concealment, the randomization sequence was placed in sequentially numbered, opaque, sealed envelopes. After a participant was confirmed eligible and formally enrolled, the next envelope in sequence was opened to reveal the assigned group. The principal investigator and the healthcare provider delivering the intervention were unaware of the allocation sequence prior to assignment. Due to the nature of the interventions (VR game intervention, mobile application use, or face‑to‑face counseling), blinding of participants and intervention providers was not feasible. However, to minimize potential bias, data analysis was conducted using anonymized group labels, so that the data analyst remained blinded to the actual group identities during statistical analysis.

Due to the nature of the intervention, blinding of participants and intervention providers was not feasible. However, data analysts were blinded to group allocation; all datasets were anonymized and provided with coded labels that contained no information about the intervention type. The analyst received only de‑identified data files and had no knowledge of the participants’ assigned groups.

SPSS file named Diabetes Gamification

Data is available upon reasonable request

Practitioniers / Spacialists in health / psychology expertise

Research Criteria in Health Interventions

SPSS file located in google drive

Formal request to first author/ Ruhollah Solat via email