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Effects of Aromatherapy on Nausea Levels

NCT ID: NCT04882501

Last Updated: 2024-11-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-19

Study Completion Date

2022-09-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Nausea, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blinded, parallel arm, placebo- controlled, randomized clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Actual aromatherapy product

QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization

Group Type ACTIVE_COMPARATOR

QUEASEEase aromatherapy quick tab

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Placebo product

Intervention Type OTHER

Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.

Interventions

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QUEASEEase aromatherapy quick tab

Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.

Intervention Type OTHER

Placebo product

Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inova Health Care Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Ann Friesen, PhD, RN

Role: STUDY_DIRECTOR

IHS

Locations

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Inova Fair Oaks Hospital

Fairfax, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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U19-07-3670

Identifier Type: -

Identifier Source: org_study_id