Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorEge University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Having previously had a diabetic foot ulcer or currently having a diabetic foot ulcer
Having a severe/uncontrolled comorbid disease
Wishing to withdraw from the study
Trial design
Design model
Parallel
Treatments tested in this trial
"Health for My Feet" virtual reality program.
BehavioralIn addition to their routine treatment and monitoring, individuals in this group will be included in the "Health for My Feet" virtual reality program.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: StudyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Total Score of the Diabetic Foot Knowledge Scale
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.
Time frame
Baseline, 1 month post-intervention, and 3 months follow-upSecondary outcomes
1
Change in Total Score of the Diabetic Foot Health Nurse Follow-up Form
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.
Time frame
Baseline and 3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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