Clinical trial NCT02764567: Essential Oil Aromatherapy Intervention
Official title: Essential Oil Aromatherapy Intervention: Easing the Discomforts of Phlebotomy With Essential Oil Aromatherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phobia Phlebotomy
Lead sponsor: HealthEast Care System
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Pain Scores
timeFrame: At the time of study enrollment and again upon completion at 6 months
measure: Change in Anxiety Scores
timeFrame: At the time of study enrollment and again upon completion at 6 months
Secondary outcomes:
measure: Number of venipunctures needed to collect required sample
timeFrame: At the time of study completion at 6 months
measure: Number of blood collection tubes required for sample
timeFrame: At the time of study completion at 6 months
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthEast Clinical Trials Office
state: Minnesota
Study officials:
affiliation: HealthEast Care System
name: Beth Jorgeonson, RN, BSN
role: PRINCIPAL_INVESTIGATOR
References: