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Completed

NCT Number: NCT07586423

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malatya Turgut Özal University Training and Research Hospital

Malatya, 4400, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Other names: VR GLASSES, Standard Diabetic Foot Care

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

Other outcomes

  1. Change in Body Temperature

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

    Body temperature (°C) measured using a non-contact infrared thermometer (Life Net Medical JA-11C). Change is calculated as post-test value minus pre-test value.

  2. Change in Oxygen Saturation (SpO₂)

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

    Peripheral oxygen saturation (SpO₂, %) measured using a fingertip pulse oximeter (Life Net Medical PFX033). Change is calculated as post-test value minus pre-test value.

  3. Change in Pulse Rate

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

    Pulse rate (beats per minute) measured using a fingertip pulse oximeter (Life Net Medical PFX033). Change is calculated as post-test value minus pre-test value.

  4. Change in Respiratory Rate

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

    Respiratory rate (breaths per minute) assessed by direct observation and counting by the researcher. Change is calculated as post-test value minus pre-test value.

  5. Change in Systolic Blood Pressure

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

    Systolic blood pressure (mmHg) measured using an upper-arm automated sphygmomanometer (Omron M3 Comfort HEM-7155-E) after the participant had been seated and resting for at least 5 minutes. Change is calculated as post-test value minus pre-test value.

  6. Change in Diastolic Blood Pressure

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

    Diastolic blood pressure (mmHg) measured using an upper-arm automated sphygmomanometer (Omron M3 Comfort HEM-7155-E) after the participant had been seated and resting for at least 5 minutes. Change is calculated as post-test value minus pre-test value.

Sponsors and collaborators

Lead sponsor

Malatya Turgut Ozal University

Other

Registry information

Official study title

The Effect of Virtual Reality Intervention on Pain Level, State Anxiety, and Vital Signs During Foot Care in Individuals With Diabetic Foot Ulcers

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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