Ingrown Toenail, Virtual Reality
Conditions
Keywords
ingrown toenail, anxiety, pain
Brief summary
Ingrown toenail is a common condition that may cause significant pain, functional impairment, and recurrent disease. Although conservative management is appropriate for mild cases, moderate-to-severe or recurrent ingrown toenails are commonly treated surgically under local anesthesia. However, pain associated with the digital nerve block and procedure-related anxiety may negatively affect the patient experience. Virtual reality (VR) has emerged as a promising non-pharmacological intervention for reducing pain and anxiety during a variety of medical procedures by providing an immersive distraction. Nevertheless, evidence regarding its use during ingrown toenail surgery remains limited. The primary objective of this study is to evaluate the effect of VR on procedure-related pain intensity and anxiety in adults undergoing outpatient ingrown toenail surgery under local anesthesia compared with standard care. Secondary objectives include assessing the effects of VR on physiological arousal parameters, patient satisfaction, and safety.
Interventions
OTHERVirtual Reality (VR)
Participants will wear a virtual reality headset with headphones during outpatient ingrown toenail surgery performed under local anesthesia. The VR intervention consists of immersive nature-based audiovisual content, including forest, ocean, and tropical beach environments accompanied by relaxing natural sounds, and is used as a non-pharmacological distraction technique throughout the procedure.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-65 years. * Patients presenting to the Dermatology Outpatient Clinic of Ankara Bilkent City Hospital with ingrown toenails who are scheduled for surgical treatment based on the severity and recurrence of the condition. * Ability to provide written informed consent.
Exclusion criteria
* Inability to read, understand, or sign the informed consent form. * Active infection, including infection at the surgical site. * History of epilepsy or seizures of any etiology * Hearing impairment or requirement for a hearing aid that would interfere with the VR intervention or study instructions. 6. Presence of a cardiac pacemaker or any implanted medical device. * History of neurological disorders (e.g., migraine). * Inability to understand or speak Turkish. * Active psychiatric disorder, use of anxiolytic or antidepressant medication that may influence anxiety assessment, panic disorder, or claustrophobia. * Visual impairment preventing the use of the VR device. * Cardiac or metabolic disorders that may affect heart rate. * History of vertigo. * Cervical spine disorders involving the head or neck region. * Known anemia, history of methemoglobinemia, or glucose-6-phosphate dehydrogenase (G6PD) deficiency. * Known allergy to local anesthetics. * Previous ingrown toenail surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State anxiety score | Baseline (before the procedure) and 30 minutes after completion of the procedure. | State anxiety assessed using the State-Trait Anxiety Inventory-State (STAI-State) questionnaire. Scores range from 0 to 80, with higher scores indicating greater anxiety. |
| Pain intensity (Visual Analog Scale, VAS) | Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after completion of the procedure. | Pain intensity measured using a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10. The effect of virtual reality on procedure-related pain will be evaluated by comparing VAS scores between the study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after the procedure. | Heart rate (beats/min) measured to evaluate physiological arousal associated with the procedure. |
| Blood pressure | Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after the procedure. | Systolic and diastolic blood pressure (mmHg) measured to assess physiological responses to the procedure. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEsra Kiratli Nalbant, Assistant Professor
CONTACTYeser Gungor, Specialist
PRINCIPAL_INVESTIGATOREsra Kiratli Nalbant, Assistant Professor
Ankara City Hospital Bilkent
Outcome results
None listed