Clinical trial NCT03122574: The Effects of Aromatherapy on the Incidence and Severity of Acute Pain
Official title: A Feasibility Study of the Effects of Aromatherapy on the Incidence and Severity of Acute Pain in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venipuncture
Keywords: aromatherapy
pediatric
venipuncture
lavender
pain management
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: American University
First posted: 2017-04-21
Enrollment: 21
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Minute 10
Secondary outcomes:
measure: Physiological-heart rate
timeFrame: Minute 3, Minute 5, Minute 7
measure: Psychological- Visual Analogue Scale (VAS) for pain
timeFrame: Minute 10
measure: Psychological- Hospital Fears Rating Scale (HFRS)
timeFrame: Minute 1, Minute 10
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Katherine B Curtin, MA
role: PRINCIPAL_INVESTIGATOR
References: