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NCT Number: NCT07707726

Virtual Reality in Ingrown Toenail Surgery

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.

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Key information

Conditions

Ingrown Toenail Anxiety Disorders Mental Disorders Nail Diseases Nails, Ingrown Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Virtual Reality

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

  1. State anxiety score

    Time frame: 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.

  2. Pain intensity (Visual Analog Scale, VAS)

    Time frame: 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 outcomes

  1. Heart rate

    Time frame: 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.

  2. Blood pressure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esra Kiratli Nalbant, Assistant Professor

CONTACT

[email protected]

+905069173233

Yeser Gungor, Specialist

CONTACT

[email protected]

+905326857261

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Effect of Virtual Reality Headset Use on Pain and Anxiety in Patients Undergoing Ingrown Toenail Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 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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