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临床试验/NCT06355492
NCT06355492尚未招募4 期

Effectiveness of Virtual Reality Distraction During Infiltration Anesthesia in Pediatric Patients.

Tanta University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
入组人数
150
试验地点
2
主要终点
Assessment of pain during virtual reality distraction

研究概览

简要总结

The aim of this study is to evaluate the effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients.

详细描述

Proper pain control and discomfort reduction during dental treatment, especially among children, can maximize a child's cooperation, overall satisfaction, build a good dentist-patient relationship, and enhance patient compliance. Psychological and pharmaceutical methods, and their combinations have tried to address this pain. Pharmaceutical approaches include the application of topical anesthetics. Psychological and behavioral modification methods including active distractions, deep breathing, Witaul and eye movement distractions. Passive distraction methods, such as audiovisual glasses and video distraction. Other methods, such as precooling the injection site, warming the local anesthesia, and camouflaging the syringe, have also been suggested.

A range of fear management techniques have been described in the literature and American Academy of Pediatric Dentistry (AAPD) has described some concepts as basic behavior guidance such as communication, tell show do, voice control, nonverbal communication, positive reinforcement, distraction and parental absence/presence, and advanced behavior guidance such as protective stabilization, sedation and general anesthesia.

Distraction as a behavior guidance technique is defined by the American Academy of Pediatric Dentistry (AAPD) as the technique of diverting the patient's attention from what may be perceived as an unpleasant procedure.

Audiovisual distraction techniques are used in dental clinics and have shown great results in managing anxious pediatric patients.

Virtual reality (VR) distraction, defined as a human-computer interface that enables the user to interact dynamically with the computer- generated environment is a new method in the medical field with the aim of aiding in patient behavior management. It offers the advantage of an immersive virtual experience blocking out external stimuli that may provoke a negative attitude, especially in young patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children with no systemic illness.
  • Cooperative child with frankels behavior rating scale positive or definitely positive.
  • Patient requiring infiltration LA for dental treatment.
  • Children with proper parental consent.
  • Patients who needed non-urgent dental treatment.

排除标准

  • Medical disability such as history of seizures, convulsion disorder, vertigo, eye problems and autism.
  • Children below 5 years of age.

结局指标

主要结局

Assessment of pain during virtual reality distraction

时间窗: After 2 weeks from the first visit.

During local anesthesia administration, the face, legs, activity, cry, consolability (FLACC) behavioral pain assessment scale (objective scale) will be recorded to assess pain. Immediately after anesthetic administration, the patients will be placed in upright position and will be shown Wong-Baker faces pain rating scale (subjective scale) and give a brief explanation to the child about each face and instruct the child to choose the face that describe their feeling during administration of local anaethesia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rokia Abdelrhman Saad Elfaramawy

Pediatric Dentistry, Oral Health and Preventive Dentistry Department

Tanta University

研究点 (2)

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