Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Change in Total Score of the Diabetic Foot Knowledge Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
This group will not receive any intervention and will receive their routine care and treatment.
Study
This group will receive VR-based intervention and will receive their routine care and treatment.
干预措施: "Health for My Feet" virtual reality program. (Behavioral)
结局指标
主要结局
Change in Total Score of the Diabetic Foot Knowledge Scale
时间窗: 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.
次要结局
- Change in Total Score of the Diabetic Foot Health Nurse Follow-up Form(Baseline and 3 months)