Behavioural Acceptability of the PARO Therapeutic Robot During Dental Treatment in Children With Cooperation Difficulties Following Unsuccessful Conventional Care: a Descriptive Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Behavioural acceptability of PARO based on voluntary physical contact
研究概览
简要总结
Socially assistive robots are increasingly being studied as tools to support children during healthcare procedures. This observational study aimed to assess the behavioural acceptability of the PARO therapeutic zoomorphic robot, designed in the form of a baby seal, during dental treatment in children aged 4 to 15 years with cooperation difficulties following unsuccessful conventional behavioural management. Behavioural acceptability was assessed by measuring the proportion of the dental treatment session during which the child voluntarily maintained physical contact with PARO. High behavioural acceptability was defined as voluntary physical contact maintained for at least 75% of the treatment time. The study also assessed changes in the children's behaviour during the dental appointment, their spontaneous reactions to PARO, and the perceptions of the children, their carers and the dental practitioners."
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 15 years referred following unsuccessful conventional dental management, defined as the inability to carry out the planned dental treatment because of anxiety or cooperation difficulties.
排除标准
- •Known fear of animals.
研究组 & 干预措施
Children Exposed to PARO
PARO is a socially assistive zoomorphic therapeutic robot designed in the form of a baby seal. It was introduced to the child before dental treatment. After a familiarisation period, the child was free to interact with PARO and to keep or remove the robot during the treatment session. Dental treatment was provided according to usual clinical needs.
干预措施: PARO socially assistive therapeutic robot (Device)
结局指标
主要结局
Behavioural acceptability of PARO based on voluntary physical contact
时间窗: During the dental treatment session at inclusion, from the start to the end of dental treatment.
Behavioural acceptability was measured as the percentage of dental treatment time during which the child voluntarily maintained physical contact with PARO. Values ranged from 0% to 100%, with higher percentages indicating greater behavioural acceptability. High behavioural acceptability was predefined as voluntary physical contact maintained for at least 75% of the treatment time.
次要结局
- Clinical behaviour assessed using the Venham scale modified by Veerkamp(At four time points during the dental treatment session: before PARO introduction, immediately after PARO introduction, throughout dental treatment, and at the end of the session.)
- Perceptions of PARO by children(At the end of the dental visit.)
- Perceptions of PARO by carers(At the inclusion)
- Perceptions of PARO by dental practitioners(At the inclusion)