AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)

Hackensack Meridian Health

Status: Completed

Conditions: Vomiting; Nausea; Anxiety

Treatments: Other: Elequil Aromatabs

Study type: Interventional

Funder types: Other

Identifiers

NCT03621722

PRO2017-0162

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

Anxiety Arm (Treatment)

Experimental group

Description:

Patient will receive Elequil Aromatabs

Treatment:

Other: Elequil Aromatabs

Nausea/Vomiting Arm (Treatment)

Experimental group

Description:

Patient will receive Elequil Aromatabs

Treatment:

Other: Elequil Aromatabs

Nausea/Vomiting Arm (Control)

No Intervention group

Description:

Patient will not receive Elequil Aromatabs

Anxiety Arm (Control)

No Intervention group

Description:

Patient will not receive Elequil Aromatabs