Virtual Reality in Ingrown Toenail Surgery

Ankara City Hospital Bilkent66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Ingrown Toenail Virtual Reality

Virtual Reality (VR)OTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

State anxiety score

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.

Time frame: Baseline (before the procedure) and 30 minutes after completion of the procedure.

Pain intensity (Visual Analog Scale, VAS)

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.

Time frame: Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after completion of the procedure.

Secondary Outcomes

Heart rate

Heart rate (beats/min) measured to evaluate physiological arousal associated with the procedure.

Time frame: Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after the procedure.

Blood pressure

Systolic and diastolic blood pressure (mmHg) measured to assess physiological responses to the procedure.