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

NCT03122574 — Not applicable, Completed, 21 participants, Children's National Research Institute

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

Registry	NCT03122574
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	21 (Actual)
Sponsor	Children's National Research Institute (Other); collaborators: American University
Conditions	Venipuncture
Interventions	Lavender Aromatherapy, Jojoba Aromatherapy (Other)
Dates	start 2015-11-01, primary completion 2016-02-01, completion 2016-02-01, first posted 2017-04-21, last updated 2017-04-21
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Treatment	Experimental	Other: Lavender Aromatherapy	Pure (100%) lavender aromatherapy
Placebo Control	Placebo comparator	Other: Jojoba Aromatherapy	Pure (100%) jojoba aromatherapy
Standard of care Control	No intervention		No aromatherapy control group

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.

+Outcome measures

Primary outcomes

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. [Minute 10]: Adverse event: defined as verbalization of headache, nausea, or dislike of fragrance.

Secondary outcomes

Physiological-heart rate [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.
Psychological- Visual Analogue Scale (VAS) for pain [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.
Psychological- Hospital Fears Rating Scale (HFRS) [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.

+Eligibility

Sex: All, ages: 7 Years to 11 Years, 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

+Locations (1)

Facility	City	Country	Status
Children's National Health System	Washington D.C., District of Columbia	United States

+Investigators

Katherine B Curtin, MA, Principal investigator, Children's National Research Institute

My Notes

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