Ingrown ToenailNCT07707726
Virtual Reality in Ingrown Toenail Surgery
A study testing Virtual Reality (VR) in people with Ingrown Toenail and Virtual Reality, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ingrown Toenail, Virtual Reality
- What is being tested?
- Virtual Reality (VR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jul 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
Akın Aktas, Professor, +903125526000, ankarasehir@saglik.gov.tr
About this study
Official title: 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.
- Conditions
- Ingrown Toenail, Virtual Reality
- Being tested
- Virtual Reality (VR)
- Keywords
- ingrown toenail, anxiety, pain
- Medical subject headings
- Nails, Ingrown, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after completion of the procedure.
Secondary outcomes (2)
Heart rate
Heart rate (beats/min) measured to evaluate physiological arousal associated with the procedure.
Measured: 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.
Measured: Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start22 Jul 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ingrown ToenailStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA KIRATLI NALBANT, Ankara City Hospital Bilkent
- Investigators
- Esra Kiratli Nalbant, Assistant Professor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707726
- Sponsor's protocol ID
- 2026-1
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36795410Goktay 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.
PubMed 26040581Exley 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.
PubMed 37674170
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Headset Use on Pain and Anxiety in Patients Undergoing Ingrown Toenail Surgery
- ClinicalTrials.gov ID
- NCT07707726
- Acronym / sponsor ID
- 2026-1
- Conditions
- Ingrown Toenail, Virtual Reality
- Keywords
- ingrown toenail, anxiety, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Other: Virtual Reality (VR)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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | VR group |
Primary outcome
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.
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 36795410Wong 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.
- Background: PubMed 26040581Goktay 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.
- Background: PubMed 37674170Exley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esra Kiratli Nalbant, Assistant Professor principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) in people with Ingrown Toenail and Virtual Reality, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra Kiratli Nalbant, Assistant Professor (+905069173233, eekiratli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State anxiety score (time frame: Baseline (before the procedure) and 30 minutes after completion of the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07707726, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.