跳至主要内容
临床试验/NCT06058533
NCT06058533已完成不适用

The Effectiveness of Pre-Visit Positive Imagery in Reducing Dental Anxiety

University of Southern California2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Dental Anxiety

研究概览

简要总结

The purpose of this study is to determine whether pre-visit positive imagery has an impact in decreasing dental anxiety and fear in pediatric patients as well as increasing patient cooperation during treatment visits. Patients needing at least 1 composite filling with nitrous and local anesthetic will receive a picture book if they are selected in the experimental group, and no picture book if they are in the control group. Patients will be asked to be fill out a pre-operative survey and post-operative survey asking how they feel about treatment. Parents will also be asked to fill out a post-operative survey.

详细描述

This study is a prospective randomized control trial. The study will be conducted at the Herman Ostrow School of Dentistry Pediatric Dental Clinic and Healthy Smiles for Kids of Orange County clinic. Established patients of record that are 4-10 years old who meet the inclusion criteria will qualify.

Participants will be randomly assigned to two groups by flipping a coin and having pre-assigned envelopes in numeric order for each participant. The envelopes will be made ahead of time with heads representing Group 1 and tails representing Group 2. The envelopes will then be numbered and stored in a folder; once a participant consents to enroll in the study, the envelope will be drawn in numeric order determining the participants group number to ensure it is randomized, Group 1 will include patients receiving positive pre-visit imagery. Group 2 will be the control group and will not receive any form of positive pre-visit imagery. The positive pre-visit imagery group 1 will receive a picture book explaining their dental treatment appointment with pictures and some words. The picture book will be a hard copy and will be shown to them by a faculty advisor at USC and by the PI at Healthy Smiles for Kids. The patient's behavior will initially be assessed at their new patient or recall appointment based off the Frankl behavior scale. At the end of the treatment visit, patient behavior will be measured by the dental provider using the Frankl behavior scale. The dentists rating the behavior will be calibrated to ensure there is consistency in the Frankl scale rating and criteria for each score.

Patients will also be asked to fill out a pre- and post-survey that allows them to express their level of dental fear and anxiety before and after the appointment using the Venham Picture Test. The total time commitment will be about 20 minutes and will be a part of their normal dental visit, no additional time is needed. Parents/caregivers will also be given a post-operative survey asking whether they felt the pre-visit positive imagery helped improve patient's behavior.

研究设计

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

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients that are healthy with no systemic conditions and are considered ASA I or ASA II
  • Patients who have never had any form of dental treatment before.
  • Patients who need at least 1 filling to be restored with composite due to caries and will need local anesthetic and nitrous oxide inhalation.
  • English speaking patients

排除标准

  • Patients with a visual impairment
  • Patients with developmental delays that are unable to read or interpret pictures for their age-level.
  • Patients whose treatment changes to something other than composite
  • Patients who refuse to wear nitrous hood.
  • Patients who are unable to read and comprehend English.

结局指标

主要结局

Dental Anxiety

时间窗: 1 day (1 hour during their dental visit)

Patients will also be asked to fill out a pre- and post-survey that allows them to express their level of dental fear and anxiety before and after the appointment using the Venham Picture Test. The total time commitment will be about 20 minutes and will be a part of their normal dental visit, no additional time is needed.

Patient Behavior

时间窗: 1 day (1 hour during their dental visit)

Parents/caregivers will also be given a post-operative survey asking whether they felt the pre-visit positive imagery helped improve patient's behavior.

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

Catherine Pham

Assistant Professor of Clinical Dentistry

University of Southern California

研究点 (2)

Loading locations...

相似试验