The Effects of Aromatherapy on the Incidence and Severity of Acute Pain

Completed · Not applicable · Has a placebo group

Conditions studied: Venipuncture

In brief

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.

Key facts

Study ID

NCT03122574

Run by

Children's National Research Institute

People needed

21

Starts

2015-11-01

Expected to finish

2016-02-01

Last updated by the study team

2017-04-21

Who can join

Age: 7 and older, up to 11. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Children's National Health System — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.