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Not yet recruiting NCT07707726

Virtual Reality in Ingrown Toenail Surgery

No phase Interventional Ingrown Toenail Virtual Reality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality (VR).
Who it may be relevant to
Registry conditions: Ingrown Toenail, Virtual Reality. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Interventions

  • Other Virtual 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.

Primary outcome measures

  • State anxiety score [Time frame: Baseline (before the procedure) and 30 minutes after completion of the procedure.]
  • 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.]
Secondary outcome measures (2)
  • Heart rate [Time frame: Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after the procedure.]
  • Blood pressure [Time frame: Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after the procedure.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Bilkent City Hospital — Ankara

Publications

  • Wong CL, Choi KC. Effects of an Immersive Virtual Reality Intervention on Pain and Anxiety Among Pediatric Patients Undergoing Venipuncture: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230001. doi: 10.1001/jamanetworkopen.2023.0001. PMID 36795410
  • Goktay F, Altan ZM, Talas A, Akpinar E, Ozdemir EO, Aytekin S. Anxiety Among Patients Undergoing Nail Surgery and Skin Punch Biopsy: Effects of Age, Gender, Educational Status, and Previous Experience. J Cutan Med Surg. 2016 Jan;20(1):35-9. doi: 10.1177/1203475415588645. Epub 2015 Jun 3. PMID 26040581
  • Exley V, Jones K, O'Carroll G, Watson J, Backhouse M. A systematic review and meta-analysis of randomised controlled trials of surgical treatments for ingrown toenails part II: healing time, post-operative complications, pain, and participant satisfaction. J Foot Ankle Res. 2023 Sep 6;16(1):55. doi: 10.1186/s13047-023-00655-7. PMID 37674170

Identifiers

NCT: NCT07707726 · 2026-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗