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临床试验/NCT07702045
NCT07702045尚未招募不适用

Dental Play Intervention Before Restorative Care in Children

Geisinger Clinic0 个研究点目标入组 20 人开始时间: 2026年7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
尚未招募
入组人数
20
主要终点
Measure the impact on play therapy for dental patients

研究概览

简要总结

This pilot study designed to evaluate the feasibility and potential impact of play-based interventions on pediatric dental patients. The intervention consists of a structured dental play session prior to restorative treatment, aimed at reducing anxiety and improving behavioral cooperation. Data will be collected during and after the procedure, focusing on observed behavior and responses to standardized assessments.

详细描述

The purpose of this pilot study is to evaluate whether a structured dental play intervention can reduce dental anxiety and improve behavioral cooperation and treatment acceptance among pediatric patients undergoing restorative care. Dental play involves familiarizing children with common dental instruments-such as mirrors, composite guns, and acid etch containers-by allowing them to interact with these items before their procedure.

This prospective randomized controlled pilot study will include participants aged 3-6 years who present to the pediatric dental clinic for restorative treatment. Participants included will be American Society of Anesthesiologists (ASA) Physical Status I or II and have no pre-existing behavioral or neurological conditions that could influence anxiety or cooperation.

Participants will be randomly assigned in a 1:1 ratio to one of two groups: an intervention group receiving a pre-appointment dental play session with a Child Life Specialist, and a control group receiving standard care without play intervention.

Previous research in medical settings demonstrates that play-based interventions can reduce anxiety and enhance patient understanding of healthcare procedures. However, limited evidence exists regarding the effectiveness of such interventions in dentistry. This study aims to explore the feasibility and preliminary impact of dental play interventions on pediatric patient behavior during restorative treatment.

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
None

入排标准

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

入选标准

  • Participants with no neurodivergent diagnosis
  • Patients who at previous NP or hygiene visit has restorative needs that require administration of local anesthesia
  • Patients who are within a score of 2-5 on the Houpt Scale

排除标准

  • Patients with a diagnosed neurodivergent syndrome
  • Patients who do not need restorative work
  • Patients who are either score 1 or 6 on the Houpt Scale, to focus on patients with mild to moderate behavior challenges who may benefit most from the intervention.
  • Patients with complex medical history that affect behavior and cooperation

研究组 & 干预措施

Control Group

No Intervention

Participants will proceed with their restorative appointment as scheduled, without any dental play intervention.

Intervention Group

Experimental

Participants will arrive 30 minutes prior to their scheduled appointment and engage in a structured 30-minute dental play session with a Certified Child Life Specialist. The session will involve safe, non-functional dental materials such as white coats, gloves, mirrors, typodonts, and empty acid etch containers, allowing children to explore and interact with these items in a supportive environment.

干预措施: Structured dental play session prior to restorative dental treatment. (Behavioral)

结局指标

主要结局

Measure the impact on play therapy for dental patients

时间窗: 1.5 hours

To understand the impact on play therapy for dental patients according to the quantitative Houpt Behavior rating scale.

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

Gayatri Malik

Pediatric Dentist

Geisinger Clinic

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