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AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT) (AMBIENT)

Primary Purpose

Anxiety, Nausea, Vomiting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elequil Aromatabs
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hackensack University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Anxiety Arm (Treatment)

Nausea/Vomiting Arm (Treatment)

Nausea/Vomiting Arm (Control)

Anxiety Arm (Control)

Arm Description

Patient will receive Elequil Aromatabs

Patient will receive Elequil Aromatabs

Patient will not receive Elequil Aromatabs

Patient will not receive Elequil Aromatabs

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Number of PRN antiemetics for prolonged standardized antiemetic regimen
These are patients who self-report blood and marrow transplant conditioning regimen induced nausea and vomiting in the treatment and control cohorts
Duration of PRN antiemetics for prolonged standardized antiemetic regimen
These are patients who self-report blood and marrow transplant conditioning regimen induced nausea and vomiting in the treatment and control cohorts
Number of PRN anxiolytics for prolonged standardized anxiolytic regimen
These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts
Duration of PRN anxiolytics for prolonged standardized anxiolytic regimen
These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts
Using the Patient Self-Report of Anxiety Assessment Tool to document the severity of anxiety prior to and following application of the patch
The level of anxiety in the hour prior to and following application of the patch for patients in the treatment arm
Using the Halpin 0-to-5 Nausea and Vomiting Scales to document the severity of nausea/vomiting prior to and following application of the patch
The level of nausea/vomiting in the hour prior to and following application of the patch for patients in the treatment arm

Full Information

First Posted
March 21, 2018
Last Updated
February 10, 2020
Sponsor
Hackensack Meridian Health
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1. Study Identification

Unique Protocol Identification Number
NCT03621722
Brief Title
AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)
Acronym
AMBIENT
Official Title
AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
October 2, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Nausea, Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anxiety Arm (Treatment)
Arm Type
Experimental
Arm Description
Patient will receive Elequil Aromatabs
Arm Title
Nausea/Vomiting Arm (Treatment)
Arm Type
Experimental
Arm Description
Patient will receive Elequil Aromatabs
Arm Title
Nausea/Vomiting Arm (Control)
Arm Type
No Intervention
Arm Description
Patient will not receive Elequil Aromatabs
Arm Title
Anxiety Arm (Control)
Arm Type
No Intervention
Arm Description
Patient will not receive Elequil Aromatabs
Intervention Type
Other
Intervention Name(s)
Elequil Aromatabs
Intervention Description
There will be a variety of different Aromatabs such as orange/peppermint or lavender
Primary Outcome Measure Information:
Title
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
Description
Differences in the severity of nausea and vomiting between patients in the treatment and control groups
Time Frame
12-hour intervals for a year
Title
Using the Patient Self-Report of Anxiety Assessment Tool to document the degree of severity of patients' self-reported anxiety
Description
Differences in the severity of anxiety between patients in the treatment and control groups
Time Frame
12-hour intervals for a year
Secondary Outcome Measure Information:
Title
Number of PRN antiemetics for prolonged standardized antiemetic regimen
Description
These are patients who self-report blood and marrow transplant conditioning regimen induced nausea and vomiting in the treatment and control cohorts
Time Frame
1 year
Title
Duration of PRN antiemetics for prolonged standardized antiemetic regimen
Description
These are patients who self-report blood and marrow transplant conditioning regimen induced nausea and vomiting in the treatment and control cohorts
Time Frame
1 year
Title
Number of PRN anxiolytics for prolonged standardized anxiolytic regimen
Description
These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts
Time Frame
1 year
Title
Duration of PRN anxiolytics for prolonged standardized anxiolytic regimen
Description
These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts
Time Frame
1 year
Title
Using the Patient Self-Report of Anxiety Assessment Tool to document the severity of anxiety prior to and following application of the patch
Description
The level of anxiety in the hour prior to and following application of the patch for patients in the treatment arm
Time Frame
one hour prior to and following application of the patch
Title
Using the Halpin 0-to-5 Nausea and Vomiting Scales to document the severity of nausea/vomiting prior to and following application of the patch
Description
The level of nausea/vomiting in the hour prior to and following application of the patch for patients in the treatment arm
Time Frame
one hour prior to and following application of the patch

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Tracey, MSN
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be handled in a confidential manner to meet mandated IT security standards and prevent loss of privacy. All electronic files will be stored in an encrypted and password-protected database on a secure medical center server. Any research data extracted from participants' medical records will be recorded in REDCap and electronic spreadsheets will be kept on a password protected computer. The information will be de-identified for study analysis. If the results of the trial are published, participants' identities will remain confidential and all data will be presented in the aggregate. Publications resulting from this research will not contain any information that could potentially identify participants, either directly or indirectly.
IPD Sharing Time Frame
6 months after publication

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AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)

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