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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esra Kiratli Nalbant, Assistant Professor | Contact | +905069173233 | eekiratli@gmail.com | |
| Yeser Gungor, Specialist | Contact | +905326857261 | yesergenc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Esra Kiratli Nalbant, Assistant Professor | Ankara City Hospital Bilkent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Ankara | Ankara | 06800 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36795410 | Background | 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. | |
| 26040581 | 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. |
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| ID | Term |
|---|---|
| D009263 | Nails, Ingrown |
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001523 | Mental Disorders |
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|
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. |
| 37674170 | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |