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临床试验/NCT01643915
NCT01643915已完成不适用

Behavior Management Using Audiovisual Tools in Pediatric Dental Patients

Universitat Internacional de Catalunya1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2012年9月1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
224
试验地点
1
主要终点
Global behavior during the treatment

研究概览

简要总结

The aim of the study was to assess whether the behavior, anxiety, and pain of pediatric patients during dental treatment improves when a cartoon film is viewed or a videogame is played as methods of distraction.

详细描述

Each patient required a minimum of 2 visits for restorative treatment in a mandibular quadrant and had undergone a previous restorative dental experience. All parents or guardians of the children who participated in the study were informed about the study before enrolment, and gave their voluntary consent. Each visit lasted approximately 35 minutes and involved restorative treatment in a mandibular quadrant with an alveolar nerve block. The parents were not present in the operating room during the treatment. The maximum time between the 2 treatment sessions was 2 weeks. Before the start of each treatment session, as a part of the standard process of a paediatric dental visit, the child was given an explanation as to what the visit would comprise, with the aim of interrupting the treatment as little as possible. The children knew at the beginning of the first appointment (control) that they would be able to watch a movie or play a videogame during their next visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
4 Years 至 9 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Patients aged 4-9 years.
  • •Patients who required a minimum of 2 visits for restorative treatment.
  • •Patients who had previously shown disruptive behavior (Frankl Behavior Rating Scale 1 or 2) during dental restorative treatment or pulp therapy.

排除标准

  • •Patients with reduced audiovisual capabilities.
  • •Patients with psychological disorders.

研究组 & 干预措施

Experimental group 1

Experimental

Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.

干预措施: Distraction method (Behavioral)

Control group

Active Comparator

Patients with conventional treatment. No distraction method during the treatment visits.

干预措施: No distraction method (Behavioral)

Experimental group 2

Experimental

Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.

干预措施: Distraction method (Behavioral)

结局指标

主要结局

Global behavior during the treatment

时间窗: 14 days

次要结局

  • Parental perception of patients' anxiety(14 days)
  • Pain during the treatment(14 days)
  • Self-reported anxiety during the treatment(14 days)
  • Heart rate during the treatment measures in different time points(14 days)
  • Degree of acceptance of the distraction method by the pediatric patient(14 days)

研究者

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

Francisco Guinot-Jimeno

DDS, MsC

Universitat Internacional de Catalunya

研究点 (1)

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