Effect of Aromatherapy on Postoperative Nausea, Vomiting

December 3, 2018 updated by: Tuğba Karaman, Tokat Gaziosmanpasa University

Evaluating the Efficacy of Aromatherapy on Postoperative Nausea, Vomiting

The aim of this study is to evaluate the effect of the aromatherapy with lavender, rose or ginger essential oils on nausea, vomiting and postoperative quality of recovery scores in patients with postoperative nausea and vomiting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative Nausea and Vomiting (PONV) relief is still challenge for the anesthesiologist. Pharmacological therapies is also cornerstone for treatment of PONV. Although future researches are needed, there is some proofs about the aromatherapy could provide an inexpensive, noninvasive and effective treatment for PONV.

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tokat, Turkey, 60100
        • Gaziosmanpasa University Medical School Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Be scheduled for elective surgery
  • Have a postoperative nausea and vomiting

Exclusion Criteria:

  • Age > 65years or <18 years
  • Not accepted to inhale lavender, rose or ginger oil
  • Preoperative predications with anti emetic drugs
  • Pregnancy or breastfeeding
  • Asthma, Chronic obstructive pulmonary disease
  • Poor sense of smell
  • Allergy to the lavender, rose or ginger oil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lavender Aromatherapy
Aromatherapy with lavender essential oil.
Procedure: Lavender Aromatherapy
the two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
Other Names:
  • Aromatherapy with lavender essential oil
Experimental: Rose Aromatherapy
Aromatherapy with rose essential oil
Procedure: Rose Aromatherapy
the two drops of rose essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
Other Names:
  • Aromatherapy with rose essential oil
Experimental: Ginger Aromatherapy
Aromatherapy with ginger essential oil
Procedure: Ginger Aromatherapy
the two drops of ginger essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
Other Names:
  • Aromatherapy with ginger essential oil
Placebo Comparator: Placebo Aromatherapy
Aromatherapy with pure water
Procedure: Placebo Aromatherapy
the two drops of pure water will be dropped into the gauze and the patient will inhale it for 5 minutes
Other Names:
  • Aromatherapy with pure water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of the nausea scores
Time Frame: During postoperative 24 hours
Nausea will be measured with verbal descriptive scale on 0 to 3 Likert-type scale(0=no nausea, 1=some, 2= a lot, 3= severe)
During postoperative 24 hours
The change of the vomiting score
Time Frame: During postoperative 24 hours
Vomiting will be measured with verbal descriptive scale (0=no vomiting, 1= 1 time, 2= 2 or 3 times, 3= 4 times and up)
During postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The consumption of the antiemetic drug
Time Frame: During postoperative 24 hours
The antiemetic drug dose will be recorded
During postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

November 13, 2018

Study Completion (Actual)

November 14, 2018

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 8, 2016

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PONV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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