Essential Oil Aromatherapy Intervention

Phobia Phlebotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764567
• Other study ID #: HE 16 04 002
• Status: Completed
• Phase: N/A
• First received: May 2, 2016
• Last updated: February 23, 2018
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: HealthEast Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Phobia Phlebotomy

Intervention

Other:
• Essential Oil
Participants in this arm will be offered one of three essential oils: ginger, lavender or calming

Locations

Country	Name	City	State
United States	HealthEast Clinical Trials Office	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthEast Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Scores		At the time of study enrollment and again upon completion at 6 months
Primary	Change in Anxiety Scores		At the time of study enrollment and again upon completion at 6 months
Secondary	Number of venipunctures needed to collect required sample		At the time of study completion at 6 months
Secondary	Number of blood collection tubes required for sample		At the time of study completion at 6 months

External 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