Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 1:13 AM
Study NCT ID:
NCT07473050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes
Sponsor:
Ege University
Organization:
Study Overview
Official Title:
Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes: A Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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: 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: