Effect of Virtual Reality on Pain, Anxiety and Vital Signs During Diabetic Foot Care

NCT07586423 | Completed

• 1 other identifier: E-30785963-020-266758
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

Virtual reality; Diabetic foot; Nursing; Pain; Anxiety; Vital signs

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care

Other Outcomes (6)

• Change in Body Temperature

  Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care

• Change in Oxygen Saturation (SpO₂)

  Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care

• Change in Pulse Rate

  Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care

Study Arms (2)

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.

Other: VR; Other: Standard Diabetic Foot Care

Control Group

ACTIVE COMPARATOR

Participants received standard diabetic foot care without virtual reality intervention.

Other: Standard Diabetic Foot Care

Interventions

VR OTHER

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.

Also known as: VR GLASSES, Standard Diabetic Foot Care

Intervention Group (VR Group)

Standard Diabetic Foot Care OTHER

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.

Control Group; Intervention Group (VR Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of chronic wounds other than diabetic foot ulcer (e.g., arterial or venous ulcers) Age under 18 years

Sponsors & Collaborators

• Malatya Turgut Ozal University: lead

Study Sites (1)

Malatya Turgut Özal University Training and Research Hospital

Malatya, Malatya, 4400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 14, 2026
• Study Start: December 9, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)