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
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|
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 (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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:
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.
- Change in Pain Scores [ Time Frame: At the time of study enrollment and again upon completion at 6 months ]
- Change in Anxiety Scores [ Time Frame: At the time of study enrollment and again upon completion at 6 months ]
- Number of venipunctures needed to collect required sample [ Time Frame: At the time of study completion at 6 months ]
- Number of blood collection tubes required for sample [ Time Frame: At the time of study completion at 6 months ]
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
|United States, Minnesota|
|HealthEast Clinical Trials Office|
|Saint Paul, Minnesota, United States, 55104|
|Principal Investigator:||Beth Jorgeonson, RN, BSN||HealthEast Care System|