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Trial record 33 of 237 for:    essential oil

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

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ClinicalTrials.gov Identifier: NCT03370328
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Maxine Fearrington, University of Rochester

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

Condition or disease Intervention/treatment Phase
Nausea Other: Peppermint oil Other: Ginger oil Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Essential Oils to Reduce Post-Operative Nausea and Vomiting
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peppermint oil
post-op surgical patients
Other: 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.

Experimental: Ginger oil
post-op surgical patients
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.

Experimental: Peppermint and ginger oil
post-op surgical patients
Other: 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.

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.




Primary Outcome Measures :
  1. Mean change in nausea score [ Time Frame: baseline to 24 hours ]
    Nausea will be score on a scale of 0-3 with zero indicated no nausea.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370328


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Maxine Fearrington, MS University of Rochester, Strong Memorial Hospital

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Responsible Party: Maxine Fearrington, Staff Nurse, University of Rochester
ClinicalTrials.gov Identifier: NCT03370328     History of Changes
Other Study ID Numbers: RSBR00069976
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peppermint oil
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics