Reducing Up-set Stomach and Vomiting After Surgery Using Essential Oils

NCT03370328 | Completed

• 1 other identifier: RSBR00069976
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if aromatherapy (essential oil) is effective at reducing up-set stomach and vomiting after surgery and in reducing the need for up-set stomach medications

Conditions

Nausea

Outcome Measures

Primary Outcomes (1)

• Mean change in nausea score

  Nausea will be score on a scale of 0-3 with zero indicated no nausea.

  baseline to 24 hours

Study Arms (3)

Peppermint oil

EXPERIMENTAL

post-op surgical patients

Other: Peppermint oil

Ginger oil

EXPERIMENTAL

post-op surgical patients

Other: Ginger oil

Peppermint and ginger oil

EXPERIMENTAL

post-op surgical patients

Other: Peppermint oil; Other: Ginger oil

Interventions

Peppermint oil OTHER

The study product is a commercial essential oil product and nasal inhaler. It is to be prepared by a trained, independent individual who will add 4 drops of one of the three oils/oil combinations. The subject will be instructed to twist off the cap and position inhaler in such a way as to allow the subject to inhale the vapors; it can be reused for multiple administrations. Essential oils have been the subject of other studies in treating nausea. If nausea is unrelieved, treatment will progress to the ordered antiemetic.

Peppermint and ginger oil; Peppermint oil

Ginger oil OTHER

The study product is a commercial essential oil product and nasal inhaler. It is to be prepared by a trained, independent individual who will add 4 drops of one of the three oils/oil combinations. The subject will be instructed to twist off the cap and position inhaler in such a way as to allow the subject to inhale the vapors; it can be reused for multiple administrations. Essential oils have been the subject of other studies in treating nausea. If nausea is unrelieved, treatment will progress to the ordered antiemetic.

Ginger oil; Peppermint and ginger oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• post-op surgical patients at least 18 years of age or older
• the ability to understand and follow directions for use of essential oils
• the ability to understand and give informed consent to study
• the ability to understand, read and write English
• ambulatory or short-stay/23-hour patients

You may not qualify if:

• History of any pulmonary disease, including but not limited to: asthma, COPD, OSA, chronic bronchitis, pulmonary and ear, nose, throat (ENT) surgery patients
• Allergy to any of the ingredients in the essential oils
• Sensitivity to strong odors

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Nausea

Interventions

peppermint oil; ginger extract

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maxine Fearrington, MS

  University of Rochester, Strong Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Nurse

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: March 12, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: September 4, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)