Essential Oil Aromatherapy Intervention

NCT02764567 | Completed

• 1 other identifier: HE 16 04 002
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Phobia Phlebotomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Aromatherapy

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Essential Oil OTHER

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

Aromatherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age
• Must be currently participating in a clinical trial at HealthEast

You may not qualify if:

• Known allergy to any of the oils used for aromatherapy
• Less than age 18
• Declined to participate

Sponsors & Collaborators

• HealthEast Care System: lead

Study Sites (1)

HealthEast Clinical Trials Office

Saint Paul, Minnesota, 55104, United States

Location

Related Links

• Healing scents. (2015). Retrieved 12/23, 2015
• Tissearnd, R. (2011). Gattefossé's burn. Retrieved 12/23, 2015

MeSH Terms

Interventions

Oils, Volatile

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Beth Jorgeonson, RN, BSN

  HealthEast Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 6, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 27, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)