Efficacy of Virtual Reality Distraction in Reducing Injection Pain and Anxiety During Local Anesthesia in Pediatric Dental Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain felt during injection using visual analogue scale
研究概览
简要总结
The aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.
The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years old requiring local anesthetic infiltration with conventional syringe (CS) for conservative treatment of two primary maxillary molars bilaterally.
Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, whereas VR is allocated to either first or second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anesthesia method - CS or CS+VR.
详细描述
Achieving local anesthesia in children is one of the critical aspects of pain management.
A contemporary engaging form of distraction is represented by virtual reality devices. Virtual reality (VR) devices create a virtual environment of view and sound that allow patients to be immersed in an interactive, simulated world to distract them from pain. The VR devices have a wide viewing field and three-dimensional displays that project the images right in front of the user. They not only show potentially attractive audio-visual stimuli, but also exclude all other visual environmental stimuli that may affect the patient.
The aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.
The device used in this study is Noon VR, FXGear, compatible with a mobile phone.
The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 8-12 years old requiring local anesthetic infiltration for conservative treatment of two primary maxillary molars bilaterally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
- •Children, requiring local anesthesia infiltration for conservative treatment of two primary upper jaw molars bilaterally.
- •Children without previous experience with local anesthesia for dental treatment.
- •Obtained informed consent from parents or gave-givers to participate in the study.
排除标准
- •Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic non-epileptic events, sensitivity to flashing light or motion.
- •Vision requiring correction with eyeglasses.
- •Recent injury to the eyes or face that prevents comfortable use of VR hardware or software.
- •Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
- •Patients with allergy to local anesthetics of the amide group.
- •Children, who are first time ever dental patients.
结局指标
主要结局
Pain felt during injection using visual analogue scale
时间窗: Immediately after local anesthetic delivery
Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.
次要结局
- Patient preference to local anesthesia method(One week after second procedure)
- Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale(During local anesthesia procedure)
- Self-reported anxiety during injection evaluated on FIS(Immediately after local anesthetic delivery)
- Heart rate dynamics of the patient(Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.)
- Assessment of self-reported dental fear on CFSS-DS questionnaire(At least 5 minutes before local anesthesia)