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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03122574
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : April 21, 2017
American University
Information provided by (Responsible Party):
Katherine Curtin, Children's Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Venipuncture Other: Lavender Aromatherapy Other: Jojoba Aromatherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Feasibility Study of the Effects of Aromatherapy on the Incidence and Severity of Acute Pain in Pediatric Patients
Actual Study Start Date : November 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment
Pure (100%) lavender aromatherapy
Other: Lavender Aromatherapy
100% pure lavender aromatherapy was administered using person essential oil diffusor sachets, consisting of three drops of oil on a surgical sponge covered in a sealed plastic packet.

Placebo Comparator: Placebo Control
Pure (100%) jojoba aromatherapy
Other: Jojoba Aromatherapy
100% pure jojoba aromatherapy was administered using person essential oil diffusor sachets, consisting of three drops of oil on a surgical sponge covered in a sealed plastic packet. This colorless, odorless oil was used as a placebo comparator.

No Intervention: Standard of care Control
No aromatherapy control group

Primary Outcome Measures :
  1. 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. [ Time Frame: Minute 10 ]
    Adverse event: defined as verbalization of headache, nausea, or dislike of fragrance.

Secondary Outcome Measures :
  1. Physiological-heart rate [ Time Frame: Minute 3, Minute 5, Minute 7 ]
    Heart rate (raw score) as measured using a NONIN Onyx finger cuff. It took approximately 10 seconds to record. Heart rate was measured (1) two-minutes prior to venipuncture, (2) during venipuncture, and (3) two minutes post-venipuncture, covering in total a 4 minute time span.

  2. Psychological- Visual Analogue Scale (VAS) for pain [ Time Frame: Minute 10 ]
    The VAS for pain is a self-report measure that assesses subjective patient pain on a scale from 0-10. It was administered at the end of the 10 minute study and took approximately one minute to administer.

  3. Psychological- Hospital Fears Rating Scale (HFRS) [ Time Frame: Minute 1, Minute 10 ]
    The Hospital Fears Rating Scale is a measure of subjective self-report patient anxiety. Scores range from 1-5.It was administered at minute one and again at minute 10 of the study.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03122574

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United States, District of Columbia
Children's National Health System
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's Research Institute
American University
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Principal Investigator: Katherine B Curtin, MA Children's Research Institute

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Responsible Party: Katherine Curtin, Clinical Research Coordinator, Children's Research Institute Identifier: NCT03122574    
Other Study ID Numbers: Pro0006362
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katherine Curtin, Children's Research Institute:
pain management
Additional relevant MeSH terms:
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Acute Pain
Neurologic Manifestations
Signs and Symptoms