AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)

Anxiety Clinical Trial

— AMBIENT  

Official title:

AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621722
• Other study ID #: PRO2017-0162
• Status: Completed
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Hackensack Meridian Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Nausea
• Vomiting

Intervention

Other:
• Elequil Aromatabs
There will be a variety of different Aromatabs such as orange/peppermint or lavender

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	one hour prior to and following application of the patch
Secondary	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	one hour prior to and following application of the patch