Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes

March 10, 2026 updated by: Aslı KALKIM, Ege University

Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes: A Randomized Controlled Study

This randomized controlled experimental study aims to develop and evaluate the effectiveness of a Virtual Reality-Based "Health to My Foot" program designed for individuals with Type II Diabetes Mellitus. The study will assess the program's impact on diabetic foot knowledge, foot care self-efficacy, foot care behaviors, and foot health outcomes.

The research will be conducted between April and October 2026 at a university hospital diabetes outpatient clinic in İzmir, Türkiye. A total of 70 participants diagnosed with Type II DM will be enrolled and randomly assigned to either the intervention group (n=35) or the control group (n=35) using stratified block randomization.

Participants in the intervention group will receive the Virtual Reality-Based "Health to My Foot" program through virtual reality goggles and will have access to a recorded foot care training video for home use. They will also receive weekly motivational reminder messages for three months. The control group will receive standard outpatient care only.

Data will be collected at baseline (pre-test), 1 month (post-test), and 3 months (follow-up) using validated scales and a nurse follow-up form to evaluate knowledge, self-efficacy, behaviors, and clinical foot health indicators. The findings are expected to contribute to sustainable patient education strategies and to support the prevention of diabetic foot complications and reduction of healthcare costs.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this study: To develop a Virtual Reality-Based "Health to My Foot" program for individuals with Type II DM and to evaluate the effect of the program on individuals' diabetic foot knowledge, foot care self-efficacy, foot care behaviors, and foot health.

Study type: A randomized controlled experimental study The question of this study: Does the Virtual Reality-Based "Health to My Foot" program have an effect on the Diabetic Foot Knowledge, Diabetic Foot Care Self-Efficacy, Foot Care Behavior, and Foot Health of Individuals with Type II Diabetes?

The hypotheses of this study:

Hypothesis 1. H1: The increase in Diabetic Foot Knowledge Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.

Hypothesis 2. H1: The increase in Diabetic Foot Care Self-Efficacy Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.

Hypothesis 3. H1: The increase in Foot Care Behavior Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.

Hypothesis 4. H1: The Diabetic Foot Health Nurse Follow-up examination data (skin condition, sensory findings, etc.) and risk classification status (low risk, medium risk, high risk) of individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied are statistically significantly more positive compared to the control group.

Study Design: The study will be conducted between April-October 2026 at the Diabetes Outpatient Clinic of the Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine, Ege University Health Application and Research Center in İzmir, Türkiye.

Participants: The population of the study will consist of all individuals diagnosed with Type II DM who apply to the specified institution. The sample of the study will consist of individuals with DM selected from the specified population between December 2025 and December 2026, who meet the inclusion criteria and agree to participate in the study. A power analysis was conducted to determine the number of patients to be included in the research sample. The power analysis was performed using GPower V 3.1.9.4. In line with the information obtained from studies in the literature, a repeated measures approach was used. Accordingly, for an effect size of f = 0.30, with α = 0.05 error and 80% power, the minimum total sample size required in two groups was calculated as 62 (with a minimum of 31 patients in each group). Considering group homogeneity and possible patient losses, the study is planned to be conducted with a total of 70 patients (experimental: 35, control: 35).

Randomization will be performed to ensure homogeneous distribution of the study groups. For this purpose, a stratified block randomization method will be used in terms of age, gender, and the pre-test mean score of the Foot Care Behavior Scale. Participants will be stratified according to age (18-45 / 46-65+), gender (female/male), and Foot Care Behavior Scale pre-test score (≥45 / <45).

To ensure allocation concealment, the "Sequentially Numbered, Opaque, Sealed Envelopes" (SNOSE) method will be used. The randomization schedule will be created via computer software by an independent person not directly involved in the study, and the sealed envelopes prepared according to this schedule will be opened sequentially after the participant is included in the study and the pre-test assessment is completed. Thus, the researcher's prior knowledge of which group (intervention or control) the next participant will be assigned to and the creation of selection bias will be prevented.

In the study, blinding cannot be performed because the researchers will know the groups in which the individuals are included. However, blinding will be applied in data analysis to minimize measurement bias. In the dataset, the groups will be coded as "Group A" and "Group B" and analyzed by an independent biostatistics expert who does not know which group received the intervention.

The population of the study will consist of all individuals diagnosed with Type II DM who apply to the specified institution. The sample of the study will consist of individuals with DM selected from the specified population between December 2025 and December 2026, who meet the inclusion criteria and agree to participate in the study. A power analysis was conducted to determine

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being over 18 years of age
  • Having been diagnosed with type 2 diabetes for at least one year
  • Having a risk level of 0, 1, or 2 according to the International Working Group on the Diabetic Foot (IWGDF) Risk Level Classification
  • Having completed primary education or higher
  • Not having hearing, speech, or visual impairments
  • Being able to use a smartphone
  • Not having received prior training in diabetic foot care
  • Being willing to participate in the study

Exclusion Criteria:

  • Having previously had a diabetic foot ulcer or currently having a diabetic foot ulcer

    - Risk level 3 according to the International Working Group on the Diabetic Foot (IWGDF) Risk Level Classification

  • Having a severe/uncontrolled comorbid disease
  • Wishing to withdraw from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
This group will not receive any intervention and will receive their routine care and treatment.
Experimental: Study
This group will receive VR-based intervention and will receive their routine care and treatment.
Behavioral: "Health for My Feet" virtual reality program.
In addition to their routine treatment and monitoring, individuals in this group will be included in the "Health for My Feet" virtual reality program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Score of the Diabetic Foot Knowledge Scale
Time Frame: Baseline, 1 month post-intervention, and 3 months follow-up
The outcome is the change in the total score of the Diabetic Foot Knowledge Scale (DFKS). The scale assesses participants' knowledge regarding diabetic foot care. Scores are calculated by summing item responses, with higher scores indicating greater knowledge. The change in total score will be calculated by comparing baseline (pre-test), 1-month post-intervention, and 3-month follow-up assessments.
Baseline, 1 month post-intervention, and 3 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Score of the Diabetic Foot Health Nurse Follow-up Form
Time Frame: Baseline and 3 months
Change in the total score of the Diabetic Foot Health Nurse Follow-up Form between baseline and 3 months. The form evaluates clinical foot health through nurse assessment of several domains including skin integrity, presence of lesions, sensory status, and nail condition. Scores are calculated by summing the item scores, with higher scores indicating poorer foot health status.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 16, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-2.1T/32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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