- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07707726
Virtual Reality in Ingrown Toenail Surgery
July 13, 2026 updated by: ESRA KIRATLI NALBANT, Ankara City Hospital Bilkent
The Effect of Virtual Reality Headset Use on Pain and Anxiety in Patients Undergoing 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Esra Kiratli Nalbant, Assistant Professor
- Phone Number: +905069173233
- Email: eekiratli@gmail.com
Study Contact Backup
- Name: Yeser Gungor, Specialist
- Phone Number: +905326857261
- Email: yesergenc@gmail.com
Study Locations
-
-
Ankara
-
Ankara, Ankara, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
-
Contact:
- Akın Aktas, Professor
- Phone Number: +903125526000
- Email: ankarasehir@saglik.gov.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR group
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.
|
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.
|
|
No Intervention: Standard Care Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
Systolic and diastolic blood pressure (mmHg) measured to assess physiological responses to the procedure.
|
Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after the procedure.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Esra Kiratli Nalbant, Assistant Professor, Ankara City Hospital Bilkent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 20, 2026
Primary Completion (Estimated)
November 15, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
July 13, 2026
First Submitted That Met QC Criteria
July 13, 2026
First Posted (Actual)
July 16, 2026
Study Record Updates
Last Update Posted (Actual)
July 16, 2026
Last Update Submitted That Met QC Criteria
July 13, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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