The Effect of Virtual Reality Headset Use on Pain and Anxiety in Patients Undergoing Ingrown Toenail Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- State anxiety score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: Virtual Reality (VR) (Other)
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.
结局指标
主要结局
State anxiety score
时间窗: 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)
时间窗: 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.
次要结局
- 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.)
研究者
ESRA KIRATLI NALBANT
Assistant Professor
Ankara City Hospital Bilkent