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Aromatherapy is the therapeutic use of essential oils from plants for the improvement of physical, emotional, and spiritual well-being. Healthcare providers play an important role in improving the care of patients with nausea. Aromatherapy is a complementary therapy that may help with post-operative nausea in the adult post-operative bariatric patient population.
The purpose of this study is to evaluate the effects of aromatherapy intervention on nausea levels with post-operative bariatric patients once they are on the surgical unit.
Subjects will be provided with information about this research study by the following means: a member of the research team- Inova Medical Group (IMG) Nurse Practitioners will discuss the research study during the patient's second pre-operative visit; study information will be uploaded to their MyChart portal; and flyers will be available in the IMG office (refer to appendix A: IMG office flyer). Interested patients will be able to fill out a brief form (refer to appendix B: Interested patient card) requesting to be contacted for further information, this form will be placed in a secure box at the reception desk or the patients can indicate interest by contacting one of the research team members. A member of the research team may need to access medical record information in order to confirm potential patient's phone number and or email address for further contact. A member of the research team will contact any interested patients and answer any questions regarding the research study. Consent will be obtained while the patient is in the peri-operative holding area on day of surgery by a member of the research team, excluding the IMG Nurse Practitioners. The research team member will determine if the patient is eligible for the study, discuss the study, answer any questions, and obtain consent (refer to appendix C: Consent). All members of the research team have completed Informed Consent Training. Once the consented post-operative bariatric patient complains of initial nausea on the Surgical Unit, the direct care nurse or research team member will ask the patient to rate their nausea level using a VAS on a 0-3 scale. Patients will be provided with either product A or B based on randomization scheme calculated by SAS (ver.9.4, Cary, NC). The patient will receive a one-time aromatherapy intervention. Nausea levels will be reassessed 5 minutes after the aromatherapy intervention. If the nausea level does not improve after the study drug intervention an antiemetic medication will be offered (refer to appendix D: Data Collection Form A).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actual aromatherapy product | Active Comparator | QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization |
|
| Placebo product | Placebo Comparator | Placebo product (normal saline) 50% chance of participant receiving based on randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QUEASEEase aromatherapy quick tab | Other | Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Measured participants self reported nausea level pre ( Baseline) and post intervention VAS 0 - no nausea VAS 1- Mild Nausea VAS 2- Moderate Nausea VAS 3 - Severe nausea | Up to 24 hours post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Participants Who Received an Anti-emetic Post Study Intervention. | This the number of patients who received an anti- emetic for nausea after receiving post study intervention. | Up to 24 hours post operatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Ann Friesen, PhD, RN | IHS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fair Oaks Hospital | Fairfax | Virginia | 22033 | United States |
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Inova Fair Oaks Hospital Started April 19, 2021 Ended August 24, 2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Actual Aromatherapy Product | QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization QUEASEEase aromatherapy quick tab: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed. |
| FG001 | Placebo Product | Placebo product (normal saline) 50% chance of participant receiving based on randomization Placebo product: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Actual Aromatherapy Product | QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization QUEASEEase aromatherapy quick tab: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Measured participants self reported nausea level pre ( Baseline) and post intervention VAS 0 - no nausea VAS 1- Mild Nausea VAS 2- Moderate Nausea VAS 3 - Severe nausea | Posted | Count of Participants | Participants | Up to 24 hours post operatively |
|
Collected from time of intervention up to 1.4 days post intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Actual Aromatherapy Product | QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization QUEASEEase aromatherapy quick tab: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator Inova Fair Oaks Hospital | InovaHCS | 703 391-4892 | Laura.McNicholl@inova.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2023 | Nov 21, 2024 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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Single blinded, parallel arm, placebo- controlled, randomized clinical trial.
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If you agree to participate in the study you will be randomized (assigned by chance) to a product group (product A or product B) and will receive either the active intervention or placebo. There is a 50% or 1 in 2 chance of you receiving either product A or product B upon your initial complaint of nausea when on the Surgical Unit. You will receive a one-time dose for your nausea using either product A or product B based on trial randomization.
| Placebo product | Other | Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed. |
|
| Placebo Product |
Placebo product (normal saline) 50% chance of participant receiving based on randomization Placebo product: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex/Gender, Customized | There were male, female and another category | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Total Number of Participants Who Received an Anti-emetic Post Study Intervention. | This the number of patients who received an anti- emetic for nausea after receiving post study intervention. | Posted | Count of Participants | Participants | Up to 24 hours post operatively. |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Placebo Product | Placebo product (normal saline) 50% chance of participant receiving based on randomization Placebo product: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed. | 0 | 58 | 0 | 58 | 0 | 58 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| VAS 2 |
|
| VAS 3 |
|