Effects of Aromatherapy on Nausea Levels

Not Applicable

Completed

Conditions: Nausea, Postoperative

Interventions: Other: QUEASEEase aromatherapy quick tab
Other: Placebo product

Registration Number: NCT04882501

Lead Sponsor: Inova Health Care Services

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 113

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Actual aromatherapy product	QUEASEEase aromatherapy quick tab	QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization
Placebo product	Placebo product	Placebo product (normal saline) 50% chance of participant receiving based on randomization

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.