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临床试验/NCT07467395
NCT07467395尚未招募不适用

Evaluation of Augmented Reality on Dental Pain and Anxiety During Primary Molars' Extraction: Randomized Controlled Clinical Trial

Sara Hazem Mohamed Rabie0 个研究点目标入组 30 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
Heart rate (HR) assessment

研究概览

简要总结

The aim of this study is to evaluate the impact of using virtual reality glasses compared to augmented reality glasses as distraction methods to reduce the dental anxiety and pain in children during extraction of primary molars.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Medically free children without visual or auditory impairment (ASA I).
  • Children aged 6-8 years.
  • Children with Frankl behaviour rating score 3 or
  • Children requiring extraction in one of their primary molars.
  • Parents who will accept to give their consent and participate in the study

排除标准

  • Children require emergency dental treatment.
  • Children with a history of epilepsy and anxiety disorder.
  • Children with previous bad dental experience.
  • Allergy to local anaesthetic drugs.

研究组 & 干预措施

Augmented Reality

Experimental

干预措施: Augmented reality glasses (Device)

Virtual Reality

Active Comparator

干预措施: VR glasses (Device)

结局指标

主要结局

Heart rate (HR) assessment

时间窗: Baseline to immediately after the procedure (within the same treatment visit).

Heart rate (HR) will be employed as an anxiety indicator, as stress or anxiety can increase it. It will be measured using a pulse oximeter. A brief demonstration using the pulse oximeter will be done, and the patient will be instructed to stay still and not to move his hands a lot in order to obtain accurate readings. The pulse oximeter will be placed on the patient's index finger.

Anxiety assessment using the Facial Image Scale (FIS)

时间窗: Baseline to immediately after the procedure (within the same treatment visit).

The FIS comprises one item with a response set of five faces (ranging from a very sad to a very smiley face). Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling.

Anxiety assessment using Venham's clinical anxiety scale

时间窗: Baseline to immediately after the procedure (within the same treatment visit).

The Venham's clinical anxiety rating scale will be used to assess the child's dental anxiety at baseline, during and after anesthesia injection and extraction procedure. The assessment will take place by the operator and the independent outcome assessor using the recorded video tapes. This objective measure scores the child's level of anxiety with a correlating behavior description It consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact.

Pain assessment using Wong-Baker FACES pain rating scale

时间窗: Baseline to immediately after the procedure (within the same treatment visit).

The Wong-Baker FACES Pain Rating Scale will be used to quantify the child's pain experience. This scale ranges from a neutral face, assigned a score of "0," indicating no pain, to a frowning face with a score of "10," representing the highest level of discomfort. The scale will be explained to the child, who will be asked to choose the face that represents how much pain he or she will feel during anesthesia injection and extraction from one of the graphic rating scales by pointing his finger at one of the six faces shown on the chart will be given to him.

Pain assessment using Face, legs, activity, cry, consolability (FLACC) scale

时间窗: Baseline to immediately after the procedure (within the same treatment visit).

FLACC behavioral pain assessment scale will be used to assess the child's dental pain during the procedure. This objective measure scores the child's level of pain with a correlating behavior description. It consists of 5 categories (F) face, (L) leg, (A) activity, (C) cry, (C) consolability each is scored from 0 to 2, which results in a total score between zero and ten. The assessment will take place by the operator and the independent outcome assessor, the assessors will assign a score to each category based on the child's response during anesthesia injection and extraction by analysis of the recorded videotapes.

次要结局

未报告次要终点

研究者

发起方
Sara Hazem Mohamed Rabie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sara Hazem Mohamed Rabie

MSc. researcher of pediatric dentistry

Alexandria University

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