Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
NCT Number: NCT03621722
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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Notify Me22 year and older
All sexes
Interventional
Not applicable
Hackensack, New Jersey, 07601, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
There will be a variety of different Aromatabs such as orange/peppermint or lavender
Time frame: 12-hour intervals for a year
Differences in the severity of nausea and vomiting between patients in the treatment and control groups
Time frame: 12-hour intervals for a year
Differences in the severity of anxiety between patients in the treatment and control groups
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
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
Time frame: 1 year
These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts
Time frame: 1 year
These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts
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
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
Hackensack Meridian Health
Other
Acronym: AMBIENT
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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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