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临床试验/NCT06056492
NCT06056492已完成不适用

Effectiveness of Children Experiencing Nitrous Oxide/Oxygen Inhalation Sedation at an Assessment Visit Before Having Treatment.

Dr Richard Balmer1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年3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
发起方
入组人数
20
试验地点
1
主要终点
Modified Child Dental Anxiety Scale

研究概览

简要总结

The purpose of this study is to find out the effect of experience of dental sedation at assessment on children's anxiety before the actual treatment session.

详细描述

Title: Effectiveness of children experiencing nitrous oxide/oxygen inhalation sedation at an assessment visit before having treatment.

Background: Dental anxiety is a common problem, affecting people of all ages, but predominantly children and adolescents. Inhalation sedation (IHS) using nitrous oxide/oxygen (N2O/O2) mixture is a pharmacological behaviour management technique that is widely used to manage dental anxiety in children. It is suggested that the use of an acclimatisation would increase the acceptability and the efficacy of N2O/O2 success. Even though the introductory appointment has been widely proposed, there have not been any studies conducted to measure the effectiveness of this appointment in improving the success of N2O/O2 sedation in children.

Aims: This study aimed to investigate the effect of experience of nitrous oxide/oxygen sedation at assessment prior to dental inhalation sedation on children's anxiety.

Methods: The study was a parallel randomised non blinded control clinical trial. Children aged five to fifteen years who were seen at the Leeds Dental Institute for dental treatment under inhalation sedation were recruited on the assessment appointment (1st visit). Both two groups received an assessment appointment, however participants of the study group tried on the mask and the nitrous oxide/oxygen sedation while the ones of the control group tried on the mask without the nitrous oxide/oxygen sedation. Following the assessment appointment, both groups received a second appointment for treatment. Dental anxiety was measured through two different methods. Primarily through the MCDASf questionnaire, which was completed once at the beginning of the assessment visit and twice at the beginning and end of the treatment visit. Secondarily anxiety was measured though the E4 wristband which participants of both groups wore throughout both appointments and recorded their Heart Rate (HR) and Skin Temperature (ST). At the end of the treatment visit, participants and their parents/legal guardians were asked to complete a feedback questionnaire related to the E4 wristband and the experience of N2O/O2 sedation at the assessment visit.

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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
None

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Patients attending the Sedation Unit for dental treatment under inhalation sedation.
  • •Children aged 5 to 15 years.
  • •ASA Class I or II.
  • •First time having inhalation sedation.

排除标准

  • •Participants who refuse to wear the mask.
  • •Language barriers where no interpreter was available
  • •Parents/Carer who refused to sign consent or children who did not assent.

研究组 & 干预措施

Control Group

Active Comparator

Participants assigned to the control group received assessment without experience N2O/O2 sedation and they tried the mask with O2 only.

干预措施: Experience of nitrous oxide sedation at assessment (Behavioral)

Study Group

Experimental

Participants assigned to the study group received assessment with experience of N2O/O2 sedation

干预措施: Experience of nitrous oxide sedation at assessment (Behavioral)

结局指标

主要结局

Modified Child Dental Anxiety Scale

时间窗: At start of recruitment. 4 weeks. 4 weeks.

Score 8-40. High score is high anxiety. Measured through MCDAS and E$ physiological wristband data

次要结局

未报告次要终点

研究者

发起方
Dr Richard Balmer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Richard Balmer

Associate Professor Paediatric Dentistry

University of Leeds

研究点 (1)

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