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Completed

NCT Number: NCT03122574

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

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.

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lavender aromatherapy

Other

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.

Jojoba aromatherapy

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Collaborators

  • American University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 21, 2017
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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