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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03621722
Recruitment Status : Active, not recruiting
First Posted : August 8, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

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.

Condition or disease Intervention/treatment Phase
Anxiety Nausea Vomiting Other: Elequil Aromatabs Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Treatment
Official Title: AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : October 2, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anxiety Arm (Treatment)
Patient will receive Elequil Aromatabs
Other: Elequil Aromatabs
There will be a variety of different Aromatabs such as orange/peppermint or lavender

Experimental: Nausea/Vomiting Arm (Treatment)
Patient will receive Elequil Aromatabs
Other: Elequil Aromatabs
There will be a variety of different Aromatabs such as orange/peppermint or lavender

No Intervention: Nausea/Vomiting Arm (Control)
Patient will not receive Elequil Aromatabs
No Intervention: Anxiety Arm (Control)
Patient will not receive Elequil Aromatabs



Primary Outcome Measures :
  1. 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 [ Time Frame: 12-hour intervals for a year ]
    Differences in the severity of nausea and vomiting between patients in the treatment and control groups

  2. Using the Patient Self-Report of Anxiety Assessment Tool to document the degree of severity of patients' self-reported anxiety [ Time Frame: 12-hour intervals for a year ]
    Differences in the severity of anxiety between patients in the treatment and control groups


Secondary Outcome Measures :
  1. Number of PRN antiemetics for prolonged standardized antiemetic regimen [ Time Frame: 1 year ]
    These are patients who self-report blood and marrow transplant conditioning regimen induced nausea and vomiting in the treatment and control cohorts

  2. Duration of PRN antiemetics for prolonged standardized antiemetic regimen [ Time Frame: 1 year ]
    These are patients who self-report blood and marrow transplant conditioning regimen induced nausea and vomiting in the treatment and control cohorts

  3. Number of PRN anxiolytics for prolonged standardized anxiolytic regimen [ Time Frame: 1 year ]
    These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts

  4. Duration of PRN anxiolytics for prolonged standardized anxiolytic regimen [ Time Frame: 1 year ]
    These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts

  5. Using the Patient Self-Report of Anxiety Assessment Tool to document the severity of anxiety prior to and following application of the patch [ Time Frame: one hour 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

  6. 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 [ Time Frame: one hour 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621722


Locations
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United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack Meridian Health
Investigators
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Principal Investigator: Megan Tracey, MSN Hackensack Meridian Health

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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT03621722     History of Changes
Other Study ID Numbers: PRO2017-0162
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6 months after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms