Virtual Reality in Ingrown Toenail Surgery

NCT07707726 | Not Yet Recruiting

• 1 other identifier: 2026-1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Ingrown Toenail; Virtual Reality

Keywords

ingrown toenail; anxiety; pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (2)

• Heart rate

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

• Blood pressure

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

Study Arms (2)

VR group

EXPERIMENTAL

Participants will undergo standard outpatient ingrown toenail surgery under local anesthesia. During the procedure, they will wear a virtual reality headset with headphones and view an immersive nature-based video accompanied by relaxing environmental sounds. All surgical and postoperative care will be identical to the control group.

Other: Virtual Reality (VR)

Standard Care Group

NO INTERVENTION

Participants will undergo standard outpatient ingrown toenail surgery under local anesthesia without the use of a virtual reality headset. All surgical procedures, perioperative management, and postoperative care will be identical to those in the VR group.

Interventions

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.

VR group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Nails, Ingrown; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esra Kiratli Nalbant, Assistant Professor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra Kiratli Nalbant, Assistant Professor

CONTACT

+905069173233; eekiratli@gmail.com

Yeser Gungor, Specialist

CONTACT

+905326857261; yesergenc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)