A Feasibility Study of the Effects of Aromatherapy on the Incidence and Severity of Acute Pain in Pediatric Patients
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
- 是
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
Katherine Curtin
Clinical Research Coordinator
Children's National Research Institute
