Virtual Reality in Ingrown Toenail Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnkara City Hospital Bilkent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality (VR)
Other interventionParticipants 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: VR groupExperimental treatment 1 intervention
Group B: Standard Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (before the procedure) and 30 minutes after completion of the procedure.2
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.
Time frame
Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after completion of the procedure.Secondary outcomes
1
Heart rate
Heart rate (beats/min) measured to evaluate physiological arousal associated with the procedure.
Time frame
Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after the procedure.2
Blood pressure
Systolic and diastolic blood pressure (mmHg) measured to assess physiological responses to the procedure.
Time frame
Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after the procedure.Sponsors and contacts
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Source ClinicalTrials.gov