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

NCT ID: NCT03370328

Last Updated: 2018-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-12

Study Completion Date

2018-06-30

Brief Summary

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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

Detailed Description

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If participants decide to take part in this study, they will be asked to use choose a small nasal inhaler from a bag, open the sealed package, and inhale from the nasal inhaler 3 times, inhaling through the nose and exhaling through the mouth, just prior to entering the operating room. During recovery in the Post-operative acute care unit (PACU), nausea severity will be rated using a 0-3 scale where zero indicates no nausea.

If your score is 1-3, participants will be instructed/assisted in using a nasal inhaler 3 times, inhaling through the nose and exhaling through the mouth. After 5 minutes, nausea scores will be collected again and if the score is the same or higher, participants will be asked to use the nasal inhaler again in the same manner as before. If their nausea has not resolved after the second use, they will be give anti-nausea medication that a surgeon ordered. This process will be repeated again whenever you complain of nausea, until they are discharged from the hospital.

Conditions

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Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Peppermint oil

post-op surgical patients

Group Type EXPERIMENTAL

Peppermint oil

Intervention Type 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

post-op surgical patients

Group Type EXPERIMENTAL

Ginger oil

Intervention Type 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

post-op surgical patients

Group Type EXPERIMENTAL

Peppermint oil

Intervention Type 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

Intervention Type 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.

Interventions

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Peppermint oil

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.

Intervention Type OTHER

Ginger oil

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Maxine Fearrington

Staff Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maxine Fearrington, MS

Role: PRINCIPAL_INVESTIGATOR

University of Rochester, Strong Memorial Hospital

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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RSBR00069976

Identifier Type: -

Identifier Source: org_study_id

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