AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)

NCT ID: NCT03621722

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2019-12-31

Brief Summary

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

Detailed 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.

Conditions

Anxiety; Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anxiety Arm (Treatment)

Patient will receive Elequil Aromatabs

Group Type: EXPERIMENTAL

Elequil Aromatabs

Intervention Type: OTHER

There will be a variety of different Aromatabs such as orange/peppermint or lavender

Nausea/Vomiting Arm (Treatment)

Patient will receive Elequil Aromatabs

Group Type: EXPERIMENTAL

Elequil Aromatabs

Intervention Type: OTHER

There will be a variety of different Aromatabs such as orange/peppermint or lavender

Nausea/Vomiting Arm (Control)

Patient will not receive Elequil Aromatabs

Group Type: NO_INTERVENTION

No interventions assigned to this group

Anxiety Arm (Control)

Patient will not receive Elequil Aromatabs

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Elequil Aromatabs

There will be a variety of different Aromatabs such as orange/peppermint or lavender

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Megan Tracey, MSN

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

Hackensack University Medical Center

Hackensack, New Jersey, United States

Countries

United States

Other Identifiers

PRO2017-0162

Identifier Type: -

Identifier Source: org_study_id