NCT06110416

Brief Summary

From the research and current studies, post-operative nausea and vomiting is a common complaint after bariatric surgery. Nausea relief inhalers could improve post-operative nausea and vomiting without the need for further medications, subsequently reducing the chance of side effects. This study could help improve patient satisfaction and increase the ability of the patient to ambulate after surgery with the use of a nausea relief inhaler.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 23, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

November 18, 2020

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Medication Administration Record

    The amount of nausea and vomiting medication use will be determined by the medication administration record during chart review in the first 24 hours for each study patient.

    "Up to 24 hours"

Secondary Outcomes (2)

  • Rhodes index

    "Up to 24 hours"

  • Length of stay

    duration of hospital stay: date of discharge minus date of admittance)

Study Arms (1)

Aromatherapy

OTHER
Other: nausea relief inhaler

Interventions

Aromatherapy and essential oils are an alternative method to controlling post-operative nausea and vomiting after post-surgical intervention.

Aromatherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 65 years old
  • Attend the pre-operative class
  • Must be able to read English
  • Admitted to B4 surgical acute unit
  • Surgery after May 31st, 2020

You may not qualify if:

  • BMI greater than 60
  • Pre-operatively on nausea medication
  • Allergy to spearmint, lemon, ginger, and/or cedarwood
  • History of Asthma or chronic obstructive pulmonary disease(COPD)
  • Patient intubated or sedated for the 24 hours after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Mansfield Medical Center

Mansfield, Texas, 76063, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Ashley Attaway, RN

    Methodist Mansfield Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

October 31, 2023

Study Start

December 23, 2020

Primary Completion

June 20, 2023

Study Completion

June 27, 2023

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations