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临床试验/NCT07722221
NCT07722221已完成不适用

Effects of Virtual Reality Technique on Some Vital Signs, Pain and Anxiety Scales During Dental Anaesthesia and Extraction in Children

Latakia University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Pain level during dental anesthesia and treatment

研究概览

简要总结

Studying the effect of using virtual reality technique in managing pain, anxiety, and vital signs among pediatric dental patients.

详细描述

Local anaesthesia is essential for pain control during pediatric dental procedures, yet its administration can cause significant anxiety and distress in children.

Recent innovations aim to improve the delivery of anesthesia to make it less painful and more acceptable. This randomized clinical trial studied the effect of using virtual reality technique in managing pain, anxiety, and vital signs among pediatric dental patients. A total of 64 healthy children aged 6 to 10 years participated in the study. The children were randomly assigned to one of two groups. Pain perception was measured using Wong-Baker FACES Pain Rating Scale. Anxiety was evaluated using Venham Picture Test. Vital signs, including pulse rate, oxygen saturation and blood pressure were monitored at baseline and during treatment. Satisfaction levels were assessed for the pediatric patients using child-friendly satisfaction questionnaires

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 (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 6-10 years.
  • Physically healthy with no neurological disorders or systemic diseases.
  • Children classified as positive" or "negative-positive" according to the modified Frankl Behavioral Rating Scale.
  • Not taking any sedatives or analgesics drugs

排除标准

  • Uncooperative children who exhibit clear behavioral problems.
  • Children with systemic diseases or disorders that may interfere with local anesthesia.
  • Use of any medications that may affect vital signs or pain response.
  • Presence of infection at the injection site.

结局指标

主要结局

Pain level during dental anesthesia and treatment

时间窗: From the start of local anesthetic injection until completion of extraction, assessed up to 30 minutes.

Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain, It's a self-reported scale with six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to point to the face that best described their pain. Higher scores on either scale indicated greater pain intensity.

Anxiety level during anesthesia and treatment

时间窗: From the start of local anesthetic injection until completion of extraction, assessed up to 30 minutes.

Anxiety was assessed using the Venham Picture Test (VPT), a self-reported measure of dental anxiety in children. The scale consists of 8 pairs of drawings, with the child selecting the picture that best reflects their feelings at each pair. Scores range from 0 to 8, where 0 indicates no anxiety and 8 indicates the highest level of anxiety. Higher scores indicate greater anxiety.

次要结局

  • Pulse rate(From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.])
  • Oxygen saturation(From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.)
  • Blood pressure(From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.)
  • Patient's satisfaction(Immediately after the procedure)

研究者

发起方
Latakia University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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