AnxietyAMBIENTNCT03621722
AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)
A study testing Elequil Aromatabs in people with Anxiety and Nausea, run by Hackensack Meridian Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- What is being tested?
- Elequil Aromatabs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
The study is comparing the difference between the use of Elequil Aromatabs versus standard of care practice treatments on Blood Marrow Transplantation patients.
Read the 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.
- Being tested
- Elequil Aromatabs
- Medical subject headings
- Anxiety Disorders, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elequil AromatabsOther
There will be a variety of different Aromatabs such as orange/peppermint or lavender
| Study group | Role | What they receive |
|---|---|---|
| Anxiety Arm (Treatment) | Experimental | Patient will receive Elequil Aromatabs Receives: Other: Elequil Aromatabs |
| Nausea/Vomiting Arm (Treatment) | Experimental | Patient will receive Elequil Aromatabs Receives: Other: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12-hour intervals for a year
Secondary outcomes (6)
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
Measured: 1 year
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one hour prior to and following application of the patch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start27 Feb 2017
- Primary completion2 Oct 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Tracey, MSN, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621722
- Sponsor's protocol ID
- PRO2017-0162
- Acronym
- AMBIENT
- Status last verified
- Feb 2020
- First submitted
- 21 Mar 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)
- ClinicalTrials.gov ID
- NCT03621722
- Acronym / sponsor ID
- AMBIENT / PRO2017-0162
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is comparing the difference between the use of Elequil Aromatabs versus standard of care practice treatments on Blood Marrow Transplantation patients.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Anxiety Arm (Treatment) | Experimental | Other: Elequil AromatabsPatient will receive Elequil Aromatabs |
| Nausea/Vomiting Arm (Treatment) | Experimental | Other: Elequil AromatabsPatient 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 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elequil AromatabsThere will be a variety of different Aromatabs such as orange/peppermint or lavender | Other | Anxiety Arm (Treatment), Nausea/Vomiting Arm (Treatment) |
Primary outcome
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
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
6 secondary outcomes
Number of PRN antiemetics for prolonged standardized antiemetic regimen
Time frame: 1 year
Duration of PRN antiemetics for prolonged standardized antiemetic regimen
Time frame: 1 year
Number of PRN anxiolytics for prolonged standardized anxiolytic regimen
Time frame: 1 year
Duration of PRN anxiolytics for prolonged standardized anxiolytic regimen
Time frame: 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
Time frame: 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
Time frame: one hour prior to and following application of the patch
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Tracey, MSN principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elequil Aromatabs in people with Anxiety and Nausea, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.