Nausea, Postoperative
Conditions
Brief summary
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.
Detailed description
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).
Interventions
OTHERQUEASEEase aromatherapy quick tab
Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
OTHERPlacebo product
Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
Sponsors
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Single blinded, parallel arm, placebo- controlled, randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients ≥ 18 years of age admitted to the Surgical Unit who are experiencing an initial episode of nausea status post laparoscopic/ robotic sleeve gastrectomy, and/or laparoscopic/robotic Roux-En-Y (RNY) surgery, and/or revisional bariatric surgery; must be able to read and speak English; able to follow directions; bariatric surgeon is part of Inova Medical Group (IMG) and patient is an inpatient.
Exclusion criteria
* Patients \< 18 years of age; non-English speaking; not able to follow directions; inability to smell (anosmia); allergy to peppermint, spearmint, ginger and/or lavender; receiving bariatric surgery for gastroparesis; pregnant or breastfeeding; vulnerable subjects; receiving complementary therapy (healing touch and/or music therapy) or presently enrolled in another research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Up to 24 hours post operatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Participants Who Received an Anti-emetic Post Study Intervention. | Up to 24 hours post operatively. | This the number of patients who received an anti- emetic for nausea after receiving post study intervention. |
Countries
United States
Participant flow
Recruitment details
Inova Fair Oaks Hospital Started April 19, 2021 Ended August 24, 2022
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| 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. | 58 |
| Total | 113 |
Baseline characteristics
| Characteristic | Actual Aromatherapy Product | Placebo Product | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 58 Participants | 113 Participants |
| Age, Continuous | 38 years | 41 years | 39.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 12 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 44 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 14 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 13 Participants | 20 Participants |
| Race (NIH/OMB) White | 32 Participants | 29 Participants | 61 Participants |
| Region of Enrollment United States | 55 participants | 58 participants | 113 participants |
| Sex/Gender, Customized Decline to answer | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Female | 52 Participants | 54 Participants | 106 Participants |
| Sex/Gender, Customized Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 58 |
| other Total, other adverse events | 0 / 55 | 0 / 58 |
| serious Total, serious adverse events | 0 / 55 | 0 / 58 |
Outcome results
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
Time frame: Up to 24 hours post operatively
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Actual Aromatherapy Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Baseline | VAS O | 0 Participants |
| Actual Aromatherapy Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Baseline | VAS 1 | 13 Participants |
| Actual Aromatherapy Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Baseline | VAS 2 | 27 Participants |
| Actual Aromatherapy Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Baseline | VAS 3 | 15 Participants |
| Actual Aromatherapy Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Post- intervention | VAS O | 16 Participants |
| Actual Aromatherapy Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Post- intervention | VAS 1 | 20 Participants |
| Actual Aromatherapy Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Post- intervention | VAS 2 | 14 Participants |
| Actual Aromatherapy Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Post- intervention | VAS 3 | 5 Participants |
| Placebo Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Post- intervention | VAS 3 | 12 Participants |
| Placebo Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Baseline | VAS O | 0 Participants |
| Placebo Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Post- intervention | VAS O | 12 Participants |
| Placebo Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Baseline | VAS 1 | 13 Participants |
| Placebo Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Post- intervention | VAS 2 | 17 Participants |
| Placebo Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Baseline | VAS 2 | 25 Participants |
| Placebo Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Post- intervention | VAS 1 | 17 Participants |
| Placebo Product | Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 | Baseline | VAS 3 | 20 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.
Time frame: Up to 24 hours post operatively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Actual Aromatherapy Product | Total Number of Participants Who Received an Anti-emetic Post Study Intervention. | 48 Participants |
| Placebo Product | Total Number of Participants Who Received an Anti-emetic Post Study Intervention. | 50 Participants |