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临床试验/NCT06966726
NCT06966726已完成不适用

Positive Pre-Visit Imagery Does Not Reduce Dental Anxiety in Children: A Randomized, Triple-Blind, Controlled Trial

Universidade Federal do Rio Grande do Norte1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2023年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
1
主要终点
Anxiety Level (Venham Picture Test - VPT)

研究概览

简要总结

This randomized triple-blind clinical trial aims to evaluate the effectiveness of positive pre-visit imagery in managing dental anxiety (DA) in children aged 5 to 13 years. DA is a common barrier to dental treatment and is often triggered by procedures such as local anaesthesia. Participants were randomly assigned to view either positive dental images or neutral nature images before treatment. Anxiety levels were assessed before and after the procedure using the Venham Picture Test. The study hypothesizes that exposure to positive dental imagery prior to the appointment may reduce anxiety levels, promoting a more positive dental experience for pediatric patients.

详细描述

Dental anxiety (DA) is a significant barrier to dental care in children and is commonly associated with negative treatment experiences, particularly during procedures such as local anaesthesia. Children with DA are more likely to exhibit poor oral health outcomes and reduced quality of life. Behaviour management techniques (BMTs), such as distraction, tell-show-do, desensitization, and positive reinforcement, are routinely used in pediatric dentistry to help reduce anxiety and improve cooperation.

Among the newer BMTs, positive pre-visit imagery-where children view positive dental-related images prior to treatment-has shown promise. This technique is based on observational learning and aims to create positive associations with dental care. However, current evidence is limited and inconclusive.

This triple-blind randomized controlled trial investigates the effectiveness of positive pre-visit imagery in reducing DA in children. Sixty-nine children aged 5 to 13 years requiring local anaesthesia were randomly assigned to view either a series of positive dental images (intervention group) or neutral nature scenes (control group) prior to treatment. The intervention consisted of four A4 laminated images designed to elicit positive emotional responses related to dental care, while the control group viewed four neutral nature photographs.

Anxiety was assessed before and after the dental procedure using the Venham Picture Test (VPT), a validated tool for evaluating dental anxiety in children. The primary outcome was the change in anxiety level between pre- and post-treatment, and the data were analyzed using non-parametric statistical methods.

The study follows CONSORT guidelines and was approved by the Human Research Ethics Committee at the Federal University of Rio Grande do Norte. This trial aims to provide robust evidence regarding the effectiveness of positive pre-visit imagery as a non-pharmacological strategy for managing dental anxiety in children.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •children aged 5-13 years who were admitted to the Paediatric Dentistry Clinic of the Federal University of Rio Grande do Norte, and who required local anaesthesia during dental treatment

排除标准

  • •Children with intellectual disabilities, visual or hearing impairments and children requiring emergency treatment were excluded

研究组 & 干预措施

Positive Imagery Group

Experimental

Participants were exposed to positive images related to dental care (e.g., smiling children after treatment, positive interactions with the dentist) for 2 minutes prior to the dental procedure.

干预措施: Positive Dental Imagery (Behavioral)

Neutral imagery group

Placebo Comparator

Participants were exposed to neutral images (nature scenes) for 2 minutes prior to the dental procedure.

干预措施: Neutral Nature Imagery (Behavioral)

结局指标

主要结局

Anxiety Level (Venham Picture Test - VPT)

时间窗: Day 1 (before and after the dental procedure)

The primary outcome of this study is to evaluate the level of dental anxiety before and after the dental procedure.

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

Lavínia Lourenço Costa

Principal Investigator

Universidade Federal do Rio Grande do Norte

研究点 (1)

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