Diabetic Foot UlcerNCT07586423
Effect of Virtual Reality on Pain, Anxiety and Vital Signs During Diabetic Foot Care
A study testing VR and Standard Diabetic Foot Care in people with Diabetic Foot Ulcer, run by Malatya Turgut Ozal University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effects of a virtual reality (VR) intervention on pain level, state anxiety, and vital signs during foot care in individuals with diabetic foot ulcers. The study was designed as a randomized controlled trial and includes 64 individuals with diabetes (intervention=32, control=32). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- VR and Standard Diabetic Foot Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older Diagnosis of Type 2 Diabetes Mellitus Diabetic foot ulcer classified as Wagner stage 3 or 4 No mental or physical condition that would interfere with communication or participation No visual or hearing impairment Ability to understand and speak Turkish Willingness to participate in the study
Who cannot join
- Presence of chronic wounds other than diabetic foot ulcer (e.g., arterial or venous ulcers) Age under 18 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Turgut Özal University Training and Research Hospital
Malatya, Malatya, 4400
About this study
Official title: The Effect of Virtual Reality Intervention on Pain Level, State Anxiety, and Vital Signs During Foot Care in Individuals With Diabetic Foot Ulcers
This study aims to determine the effects of a virtual reality (VR) intervention on pain level, state anxiety, and vital signs during foot care in individuals with diabetic foot ulcers. The study was designed as a randomized controlled trial and includes 64 individuals with diabetes (intervention=32, control=32). The intervention group will receive VR during diabetic foot care, while the control group will receive standard care. Data will be collected at pre-test and post-test using the Demographic Information Form, Vital Signs Form, State-Trait Anxiety Inventory (STAI), and Visual Analog Scale (VAS) for pain. Data analysis will be performed using SPSS 22.0.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- VR, Standard Diabetic Foot Care
- Keywords
- Virtual reality, Diabetic foot, Nursing, Pain, Anxiety, Vital signs
- Medical subject headings
- Diabetic Foot, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VROther
Also called VR GLASSES, Standard Diabetic Foot Care
Participants in the intervention group received virtual reality (VR) exposure during diabetic foot care procedures. A virtual reality headset was used as a non-pharmacological distraction method to reduce pain and anxiety. The VR intervention was applied during the procedure in addition to standard diabetic foot care. Vital signs such as blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure to evaluate physiological responses.
Standard Diabetic Foot CareOther
Participants in the control group received standard diabetic foot care according to institutional protocols, without any virtual reality intervention. Vital signs including blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (VR Group) | Experimental | Participants received virtual reality (VR) intervention during diabetic foot care procedures in addition to standard care. VR was used as a non-pharmacological distraction method during the procedure. Receives: Other: VR; Other: Standard Diabetic Foot Care |
| Control Group | Active comparator | Participants received standard diabetic foot care without virtual reality intervention. Receives: Other: Standard Diabetic Foot Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Level
Pain intensity measured using the Visual Analog Scale (VAS), a 10 cm horizontal line anchored at 0 (no pain) and 10 (worst imaginable pain). Higher scores indicate greater pain. Change is calculated as post-test score minus pre-test score.
Measured: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Secondary outcomes (1)
Change in State Anxiety
State anxiety measured using the State subscale of the State-Trait Anxiety Inventory (STAI-I), a validated 20-item self-report scale scored 20-80. Higher scores indicate greater anxiety. Change is calculated as post-test score minus pre-test score.
Measured: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start9 Dec 2024
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malatya Turgut Ozal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Özkul, Malatya Turgut Ozal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586423
- Sponsor's protocol ID
- E-30785963-020-266758
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient privacy and confidentiality concerns. The data are collected within a single institutional clinical study for academic thesis purposes and are not planned for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Intervention on Pain Level, State Anxiety, and Vital Signs During Foot Care in Individuals With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07586423
- Acronym / sponsor ID
- E-30785963-020-266758
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Virtual reality, Diabetic foot, Nursing, Pain, Anxiety, Vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Malatya Turgut Ozal UniversityUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effects of a virtual reality (VR) intervention on pain level, state anxiety, and vital signs during foot care in individuals with diabetic foot ulcers. The study was designed as a randomized controlled trial and includes 64 individuals with diabetes (intervention=32, control=32). The intervention group will receive VR during diabetic foot care, while the control group will receive standard care. Data will be collected at pre-test and post-test using the Demographic Information Form, Vital Signs Form, State-Trait Anxiety Inventory (STAI), and Visual Analog Scale (VAS) for pain. Data analysis will be performed using SPSS 22.0.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (VR Group) | Experimental | Other: VR, Other: Standard Diabetic Foot CareParticipants received virtual reality (VR) intervention during diabetic foot care procedures in addition to standard care. VR was used as a non-pharmacological distraction method during the procedure. |
| Control Group | Active comparator | Other: Standard Diabetic Foot CareParticipants received standard diabetic foot care without virtual reality intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years and older Diagnosis of Type 2 Diabetes Mellitus Diabetic foot ulcer classified as Wagner stage 3 or 4 No mental or physical condition that would interfere with communication or participation No visual or hearing impairment Ability to understand and speak Turkish Willingness to participate in the study
Key exclusion criteria (1 listed)
- Presence of chronic wounds other than diabetic foot ulcer (e.g., arterial or venous ulcers) Age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRAlso: VR GLASSES, Standard Diabetic Foot CareParticipants in the intervention group received virtual reality (VR) exposure during diabetic foot care procedures. A virtual reality headset was used as a non-pharmacological distraction method to reduce pain and anxiety. The VR intervention was applied during the procedure in addition to standard diabetic foot care. Vital signs such as blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure to evaluate physiological responses. | Other | Intervention Group (VR Group) |
| Standard Diabetic Foot CareParticipants in the control group received standard diabetic foot care according to institutional protocols, without any virtual reality intervention. Vital signs including blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure. | Other | Control Group, Intervention Group (VR Group) |
Primary outcome
Change in Pain Level
Time frame: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Pain intensity measured using the Visual Analog Scale (VAS), a 10 cm horizontal line anchored at 0 (no pain) and 10 (worst imaginable pain). Higher scores indicate greater pain. Change is calculated as post-test score minus pre-test score.
1 secondary outcome
Change in State Anxiety
Time frame: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to patient privacy and confidentiality concerns. The data are collected within a single institutional clinical study for academic thesis purposes and are not planned for public data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR and Standard Diabetic Foot Care in people with Diabetic Foot Ulcer, run by Malatya Turgut Ozal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Level (time frame: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.