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临床试验/NCT06698562
NCT06698562已完成不适用

Effect of Virtual Reality and Laser Biostimulation on Pain Perception and Dental Anxiety in Children

SIRIN GUNER ONUR2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月3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
40
试验地点
2
主要终点
Pain perception

研究概览

简要总结

Dental anxiety in children can prevent planned treatment from being carried out, negatively affect the child's relationship with the dentist and make the treatment process difficult. The most common sources of directly anticipated anxiety are known to be associated with pain. Painful experiences are anxiety-provoking for people of all ages, especially children.This study aims to evaluate the effect of virtual reality glassess (VR) and low-level laser therapy (LLLT) on dental anxiety and pain perception during local anaesthesia administration in paediatric patients.

详细描述

This study aims to investigate the combined effects of virtual reality glassess (VR) and low-level laser therapy (LLLT) on dental anxiety and pain perception in paediatric patients undergoing local anaesthesia for dental procedures. Dental anxiety is a common issue in children, often leading to increased pain perception and poor cooperation during treatment. Virtual reality has been proposed as a distraction technique, while LLLT is believed to reduce pain and inflammation. By exploring the effectiveness of these two interventions, the study seeks to determine whether VR and LLLT can serve as effective adjuncts to improve patient comfort, reduce anxiety, and enhance overall treatment experience during the administration of local anaesthesia

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, 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

  • No history of systemic disease or infectious disease
  • Compliant with the dental treatments to be performed in the Children's Dental Hospital and able to answer the questions asked
  • Exhibiting 'positive' and 'absolutely positive' behaviours during the examination, compliant according to the Frankl scale,
  • Children with no previous experience of dental treatment with local anaesthesia

排除标准

  • Children with any systemic condition
  • Mentally and physically disabled, unable to co-operate,
  • Children allergic to local anaesthesia,
  • Previous dental treatment experience with local anaesthesia
  • Exhibiting "negative" and "strongly negative" behaviour according to the Frankl scale
  • Children with eye diseases such as myopia and astigmatism

结局指标

主要结局

Pain perception

时间窗: During local anesthesia application

The "Face, Legs, Activity, Cry, Consolability (FLACC)" pain assessment scale was also evaluated during local anesthesia application by an observer clinician other than the clinician to whom local anesthesia would be applied. The patient's reactions were evaluated by observation by the researcher. Pain values were determined between 0-2 for each parameter and 0-10 for the total scale score. According to the scale, the total score was evaluated as follows: 0: No pain, 1-3: Mild pain, 4-6: Moderate pain and discomfort, 7-10: Severe pain and discomfort.

Dental Anxiety

时间窗: Right before and immediately after treatment

Dental anxiety levels of the children were physiologically evaluated using the 'Venham Picture Test'. The picture chosen by the patient was recorded on the scale. The Venham Picture Test was assessed right before and immediately after local anaesthetic injection by an observer clinician other than the clinician administering the local anesthesia. The children were shown 8 pairs of pictures of boys (one "anxious" picture and one "non-anxious" picture), each drawn in a contrasting mood, and were asked to choose the picture on each card that corresponded to their feelings. A score of 1 was given if the child chose the "anxious" picture and 0 if the child chose the "non-anxious" picture. To determine the total score, the number of "anxious" pictures was summed (lowest score 0, highest score 8).

次要结局

  • Dental Anxiety(Right before, during and immediately after the application of local anesthesia)

研究者

发起方
SIRIN GUNER ONUR
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

SIRIN GUNER ONUR

Associate Professor

Altinbas University

研究点 (2)

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