跳至主要内容
临床试验/NCT03818490
NCT03818490已完成不适用

Bergamot Aromatherapy for Anxiety in a Medical Office Among Children With Autism Spectrum Disorder: A Randomized, Controlled Trial

Franklin Health Research2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年6月24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
28
试验地点
2
主要终点
Change from baseline in Heart Rate

研究概览

简要总结

This study evaluated the use of bergamot aromatherapy in the treatment of anxiety in a medical office setting among children who are diagnosed with an autism spectrum disorder. H

详细描述

Bergamot aromatherapy relieves anxiety in adult populations but has not been tested in a pediatric population with autism spectrum disorder. Because autism spectrum disorders often include hypersensitivity to sensory experiences, the use of essential oils in this population should be evaluated.

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
Single (Participant)

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Between 6-11 years of age
  • Diagnosed with an autism spectrum disorder

排除标准

  • 未提供

研究组 & 干预措施

Bergamot Aromatherapy

Experimental

Patients in this group inhaled bergamot essential oil for 15 minutes at the start of their medical office visit.

干预措施: Bergamot Aromatherapy (Other)

Control

No Intervention

Patients in this group did not experience an intervention.

结局指标

主要结局

Change from baseline in Heart Rate

时间窗: baseline and after the 15 minute intervention

Routine heart rate measurement

Change from baseline State Trait Anxiety Inventory for Children

时间窗: baseline and after the 15 minute intervention

Self reported anxiety survey measuring state anxiety in children through 20 questions with a score ranging from 0-60 with higher scores representing higher anxiety.

Change from baseline in Blood Pressure

时间窗: baseline and after the 15 minute intervention

Routine blood pressure measurement

次要结局

未报告次要终点

研究者

发起方
Franklin Health Research
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessie Hawkins, PhD

Research Director

Franklin Health Research

研究点 (2)

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