Phobia Phlebotomy Clinical Trial
Official title:
Essential Oil Aromatherapy Intervention: Easing the Discomforts of Phlebotomy With Essential Oil Aromatherapy
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Suspended |
NCT01543009 -
Use of Local Warming in Children Venipuncture
|
Phase 0 |