Effects of Aromatherapy on Nausea Levels

NCT04882501 | Completed Results

• 1 other identifier: U19-07-3670
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Total Number of Participants Who Received an Anti-emetic Post Study Intervention.

  Up to 24 hours post operatively.

Study Arms (2)

Actual aromatherapy product

ACTIVE COMPARATOR

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

Other: QUEASEEase aromatherapy quick tab

Placebo product

PLACEBO COMPARATOR

Placebo product (normal saline) 50% chance of participant receiving based on randomization

Other: Placebo product

Interventions

QUEASEEase aromatherapy quick tab OTHER

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

Actual aromatherapy product

Placebo product OTHER

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

Placebo product

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fair Oaks Hospital

Fairfax, Virginia, 22033, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Results Point of Contact

• Title: Principal Investigator Inova Fair Oaks Hospital
• Organization: InovaHCS

Laura.McNicholl@inova.org

703 391-4892

Study Officials

• Mary Ann Friesen, PhD, RN

  IHS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blinded, parallel arm, placebo- controlled, randomized clinical trial.

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: April 19, 2021
• Primary Completion: August 22, 2022
• Study Completion: September 1, 2022
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)