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The study is comparing the difference between the use of Elequil Aromatabs versus standard of care practice treatments on Blood Marrow Transplantation patients.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anxiety Arm (Treatment) | Experimental | Patient will receive Elequil Aromatabs |
|
| Nausea/Vomiting Arm (Treatment) | Experimental | Patient will receive Elequil Aromatabs |
|
| Nausea/Vomiting Arm (Control) | No Intervention | Patient will not receive Elequil Aromatabs | |
| Anxiety Arm (Control) | No Intervention | Patient will not receive Elequil Aromatabs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elequil Aromatabs | Other | There will be a variety of different Aromatabs such as orange/peppermint or lavender |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Duration of PRN antiemetics for prolonged standardized antiemetic regimen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Tracey, MSN | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
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.
6 months after publication
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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
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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.
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These are patients who self-report blood and marrow transplant conditioning regimen induced nausea and vomiting in the treatment and control cohorts |
| 1 year |
| 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 |
| 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 |
| 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 |
| 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 |