Essential Oil Aromatherapy Intervention

Essential Oil Aromatherapy Intervention: Easing the Discomforts of Phlebotomy With Essential Oil Aromatherapy

Lab sampling for clinical trial participants can be a stressful and painful experience. Most trial participants will have blood drawn for lab samples at multiple study visits. The participants must fast for up to ten hours before the blood sampling, in many cases, and patients often report a painful experience if more than one venipuncture occurs. In addition, the number of collection tubes can increase the anxiety level of the patient and the phlebotomist.

This project proposes to evaluate if essential oil aromatherapy results in less pain and /or anxiety when compared to usual care.

Study Overview

• Status: Completed
• Conditions: Phobia Phlebotomy
• Intervention / Treatment: Other: Essential Oil

Detailed Description

The process of drawing blood for can be painful and stressful for any patient. Those patients who participate in a clinical trial agree to frequent lab sampling to monitor for effect and safety of the investigational product. The frequency is variable, from several times a day for a participant in the hospital to annually for some trials. Participants have reported anxiety regarding the number of tubes to be drawn, even resulting in near syncope, and pain with the venipuncture process.

The clinical trial nurses at HealthEast have utilized a variety of therapeutic techniques to ease the pain and anxiety experienced by the trial subjects, such as redirection, deep breathing, hand massage and guided imagery. These techniques have not been evaluated for effectiveness in easing pain and anxiety nor have they been compared with no intervention to determine if any intervention was more efficacious in alleviating pain and/or anxiety.

The primary objective of this study is determine if aromatherapy with an essential oil has a higher reported effect in anxiety and pain relief with venipunctures than standard of care (no therapy) among participants in HealthEast Clinical Trials Office studies.

Secondary objectives include comparing the number of venipunctures and blood collection tubes in the treatment arms.

This is a randomized, open label, prospective single site study designed to determine the effect of essential oil aromatherapy compared to usual care on pain and anxiety associated with venipunctures for clinical trial participants in the HealthEast Heart Care Clinic.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55104
      • HealthEast Clinical Trials Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Must be at least 18 years of age
2. Must be currently participating in a clinical trial at HealthEast

Exclusion Criteria:

1. Known allergy to any of the oils used for aromatherapy
2. Less than age 18
3. Declined to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aromatherapy; The participants randomized to aromatherapy will be offered one of three essential oils, 'applied' to their smell zone via cotton ball that are known to have anti-anxiety effect. These are: ginger; calming; lavender The participant's choice will be documented in a database. The participant can chose an oil each time (i.e., they are not bound to use only the first choice oil). Pain and anxiety will be measured prior to receiving the essential oils and again after the phlebotomy procedure. Blood pressure and pulse will also be measured post-phlebotomy.	Other: Essential Oil; Participants in this arm will be offered one of three essential oils: ginger, lavender or calming
No Intervention: Standard of Care; The participants randomized to standard of care will proceed to the outpatient phlebotomy room in the Heart Care Clinic as per usual care. Pain, anxiety, blood pressure and pulse will be assessed pre and post-procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Pain Scores	At the time of study enrollment and again upon completion at 6 months
Change in Anxiety Scores	At the time of study enrollment and again upon completion at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of venipunctures needed to collect required sample	At the time of study completion at 6 months
Number of blood collection tubes required for sample	At the time of study completion at 6 months

Collaborators and Investigators

• Sponsor: HealthEast Care System
• Investigators: Principal Investigator: Beth Jorgeonson, RN, BSN, HealthEast Care System

Publications and helpful links

Helpful Links

• Aromatherapy and essential oils (PDQ®) (2015). Retrieved 12/23, 2015
• Healing scents. (2015). Retrieved 12/23, 2015
• Tissearnd, R. (2011). Gattefossé's burn. Retrieved 12/23, 2015

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HE 16 04 002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Study results will be shared with the organization and submitted for publication. Individual participant data will not be shared.