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Essential Oil Aromatherapy Intervention

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ClinicalTrials.gov Identifier: NCT02764567
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
HealthEast Care System

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.


Condition or disease Intervention/treatment Phase
Phobia Phlebotomy Other: Essential Oil Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Essential Oil Aromatherapy Intervention: Easing the Discomforts of Phlebotomy With Essential Oil Aromatherapy
Study Start Date : May 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.



Primary Outcome Measures :
  1. Change in Pain Scores [ Time Frame: At the time of study enrollment and again upon completion at 6 months ]
  2. Change in Anxiety Scores [ Time Frame: At the time of study enrollment and again upon completion at 6 months ]

Secondary Outcome Measures :
  1. Number of venipunctures needed to collect required sample [ Time Frame: At the time of study completion at 6 months ]
  2. Number of blood collection tubes required for sample [ Time Frame: At the time of study completion at 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764567


Locations
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United States, Minnesota
HealthEast Clinical Trials Office
Saint Paul, Minnesota, United States, 55104
Sponsors and Collaborators
HealthEast Care System
Investigators
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Principal Investigator: Beth Jorgeonson, RN, BSN HealthEast Care System

Additional Information:
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Responsible Party: HealthEast Care System
ClinicalTrials.gov Identifier: NCT02764567     History of Changes
Other Study ID Numbers: HE 16 04 002
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study results will be shared with the organization and submitted for publication. Individual participant data will not be shared.