Completed

NCT Number: NCT02764567

Essential Oil Aromatherapy Intervention

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.

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Key information

Conditions

Phobia Phlebotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthEast Clinical Trials Office

Saint Paul, Minnesota, 55104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Essential Oil

Other

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

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

HealthEast Care System

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: May 6, 2016
Registry last updated: Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.