跳至主要内容
临床试验/NCT03122574
NCT03122574已完成不适用

A Feasibility Study of the Effects of Aromatherapy on the Incidence and Severity of Acute Pain in Pediatric Patients

Children's National Research Institute2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Percentage of participants who complete the intervention in the ten-minute time frame without an adverse event, assessed by stop-watch recording and RN monitoring.

研究概览

简要总结

The purpose of this research was to estimate feasibility of an aromatherapy pain management intervention to reduce pain and distress caused by venipunctures in a pediatric population. The feasibility of the use of aromatherapy essential oil lavandula angustifolia for pain management intervention (Treatment Group) was compared to placebo aromatherapy with jojoba oil (Placebo Control Group) and to the current standard of care, which is no oil during a venipuncture (Standard of Care Control Group). Primary measured outcomes were assessed using a double-blind randomized design. The physiological measure of heart rate was taken over the course of four minutes at three different intervals to note the pattern of change that occurs during anticipatory anxiety resulting from the impending procedure, the procedural pain experienced during the venipuncture, and the residual fear common after completion of the venipuncture procedure. The Visual Analogue Scale (VAS) for pain and the Hospital Fears Rating Scale (HFRS) were administered to measure subjective pain and anxiety. Participants (N=21) were recruited from the Laboratory Medicine Unit of Children's National Health System. Feasibility was estimated based on the ability to inhale the full dose of oil without adverse effects and and ability to inhale the full dose within the ten-minute time frame. This study analyzed the effect of the aromatherapy pain management intervention, lavandula angustifolia aromatherapy, on the stress response of a pediatric population through observation of physiological and psychological indicators of pain and distress, in order to learn more about the pain and anxiety experienced during venipuncture and the use of aromatherapy to decrease pain and anxiety during venipuncture.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Scheduled for venipuncture
  • English speaking
  • Parental written consent
  • Child's verbal assent

排除标准

  • Essential oil allergy
  • Peanut allergy (nut oils processed by manufacturer)
  • Medical hypersensitivity to smell
  • Asthma triggered by foreign scent
  • Frequent venipuncture (5 or more a year)
  • Current pain or anxiety medication

结局指标

主要结局

Percentage of participants who complete the intervention in the ten-minute time frame without an adverse event, assessed by stop-watch recording and RN monitoring.

时间窗: Minute 10

Adverse event: defined as verbalization of headache, nausea, or dislike of fragrance.

次要结局

  • Physiological-heart rate(Minute 3, Minute 5, Minute 7)
  • Psychological- Visual Analogue Scale (VAS) for pain(Minute 10)
  • Psychological- Hospital Fears Rating Scale (HFRS)(Minute 1, Minute 10)

研究者

发起方
Children's National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Curtin

Clinical Research Coordinator

Children's National Research Institute

研究点 (2)

Loading locations...

相似试验