AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)



Status:Active, not recruiting
Conditions:Anxiety, Anxiety
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:22 - Any
Updated:10/4/2018
Start Date:February 27, 2017
End Date:December 31, 2019

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The study is comparing the difference between the use of Elequil Aromatabs versus standard of
care practice treatments on Blood Marrow Transplantation patients.

The primary objective is to examine whether there are differences in the level of anxiety and
nausea between patients in the treatment and control groups.

The secondary objective is to compare the number of as needed (PRN) antiemetics and
anxiolytics, as well as the duration of prolonged standardized antiemetic and anxiolytic
regimen for the treatment and control cohorts.

The sample size of 200 patients is anticipated to be enrolled over a period of 1 year. A
total of 50 patients will be enrolled in each of the four groups The enrollment procedure
will begin with a screening of patients who are admitted within 24 hours of admission for
blood and marrow transplantation conditioning to evaluate if they meet the inclusion
criteria. Patients who meet inclusion criteria will be offered an opportunity to participate
in the study.

The patient will complete an informed consent form, then assessed to identify their
predominant symptom:anxiety or nausea. Based on the patients' primary symptom, they will be
randomized into either control or treatment group for a total of four groups (nausea
treatment, nausea control, anxiety treatment, and anxiety control). The study will be using a
Wei's Urn algorithm for the randomization sequence. The randomization sequence and patient
information will be stored in a protected SharePoint folder between the 8PE and 8PW nurses
enrolled with the Institutional Review Board as study staff.

Patients enrolled in the nausea control/treatment group will be required to complete a
Generalized Anxiety Disorder 7-Item Scale (GAD-7) form to determine the baseline of anxiety.

Inclusion Criteria:

- Adult blood and marrow transplant patients admitted to 8 Pavilion East Blood and
Marrow Transplant and 8 Pavilion West Blood and Marrow Transplant for autologous and
allogeneic blood and marrow transplant conditioning (chemotherapy and/or radiation
therapy) and transplant cell infusion

- Ages 22 and above. Adults ages 18-21 are admitted under the pediatric service and are
not admitted to 8PE and 8PW

- Patients with blood and marrow transplant conditioning induced nausea and vomiting-

- Patients expressing feeling of anxiety

- English and Spanish speaking only

- Patients enrolled in other research studies that allow them to participate

Exclusion Criteria:

- Patients with known allergy to lavender

- Patient with known allergy to orange/peppermint

- Patients less than 22 years

- Patients with olfactory/sinus impairment

- Patients unable to give written informed consent

- Patients admitted for inpatient conditioning but receiving transplant cell infusion in
the outpatient setting
We found this trial at
1
site
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 551-996-4495
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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mi
from
Hackensack, NJ
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