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Completed

NCT Number: NCT03621722

AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)

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

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elequil Aromatabs

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Registry information

Acronym: AMBIENT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2018
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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