ClinicalTrials.Veeva

Menu

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

Children's National logo

Children's National

Status

Completed

Conditions

Venipuncture

Treatments

Other: Jojoba Aromatherapy
Other: Lavender Aromatherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03122574
Pro0006362

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

7 to 11 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

21 participants in 3 patient groups, including a placebo group

Treatment
Experimental group
Description:
Pure (100%) lavender aromatherapy
Treatment:
Other: Lavender Aromatherapy
Placebo Control
Placebo Comparator group
Description:
Pure (100%) jojoba aromatherapy
Treatment:
Other: Jojoba Aromatherapy
Standard of care Control
No Intervention group
Description:
No aromatherapy control group

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems