Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Effect of Aromatherapy on Postoperative Nausea, Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02732379
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Tuğba Karaman, Tokat Gaziosmanpasa University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Procedure: Lavender Aromatherapy Procedure: Rose Aromatherapy Procedure: Ginger Aromatherapy Procedure: Placebo Aromatherapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Aromatherapy on Postoperative Nausea, Vomiting
Study Start Date : April 2016
Actual Primary Completion Date : November 13, 2018
Actual Study Completion Date : November 14, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Aromatherapy with pure water




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. The consumption of the antiemetic drug [ Time Frame: During postoperative 24 hours ]
    The antiemetic drug dose will be recorded



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02732379


Locations
Layout table for location information
Turkey
Gaziosmanpasa University Medical School Hospital
Tokat, Turkey, 60100
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
Layout table for investigator information
Principal Investigator: Tugba Karaman, MD Gaziosmanpasa University

Layout table for additonal information
Responsible Party: Tuğba Karaman, Assistant Professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT02732379    
Other Study ID Numbers: PONV
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Tuğba Karaman, Tokat Gaziosmanpasa University:
Postoperative Nausea and Vomiting
Aromatherapy
Quality of Health Care
Additional relevant MeSH terms:
Layout table for MeSH terms
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes