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

Venipuncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122574
• Other study ID #: Pro0006362
• Status: Completed
• Phase: N/A
• First received: April 3, 2017
• Last updated: April 17, 2017
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2017
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Venipuncture

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Children's Research Institute	American University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Adverse event: defined as verbalization of headache, nausea, or dislike of fragrance.	Minute 10
Secondary	Physiological-heart rate	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.	Minute 3, Minute 5, Minute 7
Secondary	Psychological- Visual Analogue Scale (VAS) for pain	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.	Minute 10
Secondary	Psychological- Hospital Fears Rating Scale (HFRS)	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.	Minute 1, Minute 10