NCT03130218

Brief Summary

Determine the effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 8, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

April 21, 2017

Last Update Submit

February 18, 2020

Conditions

Bariatric Surgery CandidateNausea, Postoperative

Outcome Measures

Primary Outcomes (3)

  • Nausea Assessment and Treatment Scale

    Severity of post-operative nausea on a scale of 0-10

    4 Hours

  • Count of Antiemetic Drug Therapies

    Number of antiemetic drug therapies used in the post-operative period

    4 Hours

  • Perception of Postoperative Nausea Management Survey

    Patient satisfaction with effectiveness of postoperative nausea management

    24 Hours

Study Arms (2)

Control

NO INTERVENTION

Patients in the control group will not receive peppermint oil aromatherapy as a primary intervention for postoperative nausea and vomiting. Primary therapy for postoperative nausea and vomiting would entail standard antiemetic drug therapies. Patient monitoring and documentation would include the following: Patients in the control group will be assessed every 4 hours and as needed for nausea. All aspects of care from physician, nursing and all disciplines will be consistent with current practices in care of postoperative bariatric surgical patients.

Intervention

EXPERIMENTAL

Patients in the intervention group will receive peppermint oil aromatherapy as primary treatment for postoperative nausea. Pharmacological therapy with anti-nausea drug therapies will be available as needed. All other aspects of medical, surgical and nursing care will be standard practice for pre and post-operative care related to the bariatric surgical patient. Patients in the intervention group will be assessed every 4 hours and as needed for nausea. Post-intervention, the patient will be re-assessed for level of nausea after one hour. In the event the patient refuses peppermint oil aromatherapy and requests anti-emetic drug therapies, they are able to do so.

Other: Peppermint oil aromatherapy

Interventions

Peppermint oil aromatherapyOTHER

Aroma therapy with peppermint oil administered with presoaked diffuser and bag.

Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bariatric surgery candidate on 7-Lime at Lancaster General Hospital
  • Scheduled for laparoscopic sleeve gastrectomy and laparoscopic Roux-En-Y (RNY) procedures
  • Between ages of 18 and 70
  • Surgical patient of either Dr. James Ku and Dr. Joseph McPhee

You may not qualify if:

  • History of excessive sensitivity to peppermint oil, allergic response to peppermint oil and who state preference against aromatherapy
  • Not alert and oriented or unable to follow directions will be excluded
  • Severe reactive airway disease such as asthma or chronic obstructive pulmonary disease (COPD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Related Publications (3)

  • Anderson LA, Gross JB. Aromatherapy with peppermint, isopropyl alcohol, or placebo is equally effective in relieving postoperative nausea. J Perianesth Nurs. 2004 Feb;19(1):29-35. doi: 10.1016/j.jopan.2003.11.001.

    PMID: 14770380BACKGROUND

  • Tate S. Peppermint oil: a treatment for postoperative nausea. J Adv Nurs. 1997 Sep;26(3):543-9. doi: 10.1046/j.1365-2648.1997.t01-15-00999.x.

    PMID: 9378876BACKGROUND

  • Lane B, Cannella K, Bowen C, Copelan D, Nteff G, Barnes K, Poudevigne M, Lawson J. Examination of the effectiveness of peppermint aromatherapy on nausea in women post C-section. J Holist Nurs. 2012 Jun;30(2):90-104; quiz 105-6. doi: 10.1177/0898010111423419. Epub 2011 Oct 27.

    PMID: 22034523BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized by day of week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2017

First Posted

April 26, 2017

Study Start

June 8, 2017

Primary Completion

September 10, 2019

Study Completion

December 31, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)