AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)

NCT03621722 | Completed

• 1 other identifier: PRO2017-0162
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Nausea; Vomiting

Outcome Measures

Primary Outcomes (2)

• Using the Halpin 0-to-5 Nausea and Vomiting Scales to document the degree of severity of patients' self-reported blood and marrow transplant conditioning regimen induced nausea and vomiting

  Differences in the severity of nausea and vomiting between patients in the treatment and control groups

  12-hour intervals for a year

• Using the Patient Self-Report of Anxiety Assessment Tool to document the degree of severity of patients' self-reported anxiety

  Differences in the severity of anxiety between patients in the treatment and control groups

  12-hour intervals for a year

Secondary Outcomes (6)

• Number of PRN antiemetics for prolonged standardized antiemetic regimen

  1 year

• Duration of PRN antiemetics for prolonged standardized antiemetic regimen

  1 year

• Number of PRN anxiolytics for prolonged standardized anxiolytic regimen

  1 year

• Duration of PRN anxiolytics for prolonged standardized anxiolytic regimen

  1 year

• Using the Patient Self-Report of Anxiety Assessment Tool to document the severity of anxiety prior to and following application of the patch

  one hour prior to and following application of the patch

Study Arms (4)

Anxiety Arm (Treatment)

EXPERIMENTAL

Patient will receive Elequil Aromatabs

Other: Elequil Aromatabs

Nausea/Vomiting Arm (Treatment)

EXPERIMENTAL

Patient will receive Elequil Aromatabs

Other: Elequil Aromatabs

Nausea/Vomiting Arm (Control)

NO INTERVENTION

Patient will not receive Elequil Aromatabs

Anxiety Arm (Control)

NO INTERVENTION

Patient will not receive Elequil Aromatabs

Interventions

Elequil Aromatabs OTHER

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

Anxiety Arm (Treatment); Nausea/Vomiting Arm (Treatment)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Megan Tracey, MSN

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The patient will be randomly assigned to a group based on their primary symptoms. The RN will be communicating with the patient for assessments, administering medications, and submitting results collected into the EPIC system.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients receiving Elequil Aromatabs(treatment cohort) and patients receiving Standard of care (control cohort). In addition, patients will be receiving PRN antiemetic or PRN anxiolytics

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: August 8, 2018
• Study Start: February 27, 2017
• Primary Completion: October 2, 2019
• Study Completion: December 31, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication

Locations

US (1)