Back to resultsEffect of Aromatherapy on Postoperative Nausea, Vomiting
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lavender Aromatherapy
Rose Aromatherapy
Ginger Aromatherapy
Placebo Aromatherapy
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting, Aromatherapy, Quality of Health Care
Eligibility 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
Sites / Locations
- Gaziosmanpasa University Medical School Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Lavender Aromatherapy
Rose Aromatherapy
Ginger Aromatherapy
Placebo Aromatherapy
Arm Description
Aromatherapy with lavender essential oil.
Aromatherapy with rose essential oil
Aromatherapy with ginger essential oil
Aromatherapy with pure water
Outcomes
Primary Outcome Measures
The change of the nausea scores
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)
The change of the vomiting score
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
The consumption of the antiemetic drug
The antiemetic drug dose will be recorded
Full Information
NCT ID
NCT02732379
First Posted
March 30, 2016
Last Updated
December 3, 2018
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT02732379
Brief Title
Effect of Aromatherapy on Postoperative Nausea, Vomiting
Official Title
Evaluating the Efficacy of Aromatherapy on Postoperative Nausea, Vomiting
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 13, 2018 (Actual)
Study Completion Date
November 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Postoperative Nausea and Vomiting, Aromatherapy, Quality of Health Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lavender Aromatherapy
Arm Type
Experimental
Arm Description
Aromatherapy with lavender essential oil.
Arm Title
Rose Aromatherapy
Arm Type
Experimental
Arm Description
Aromatherapy with rose essential oil
Arm Title
Ginger Aromatherapy
Arm Type
Experimental
Arm Description
Aromatherapy with ginger essential oil
Arm Title
Placebo Aromatherapy
Arm Type
Placebo Comparator
Arm Description
Aromatherapy with pure water
Intervention Type
Procedure
Intervention Name(s)
Lavender Aromatherapy
Other Intervention Name(s)
Aromatherapy with lavender essential oil
Intervention Description
the two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
Intervention Type
Procedure
Intervention Name(s)
Rose Aromatherapy
Other Intervention Name(s)
Aromatherapy with rose essential oil
Intervention Description
the two drops of rose essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
Intervention Type
Procedure
Intervention Name(s)
Ginger Aromatherapy
Other Intervention Name(s)
Aromatherapy with ginger essential oil
Intervention Description
the two drops of ginger essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
Intervention Type
Procedure
Intervention Name(s)
Placebo Aromatherapy
Other Intervention Name(s)
Aromatherapy with pure water
Intervention Description
the two drops of pure water will be dropped into the gauze and the patient will inhale it for 5 minutes
Primary Outcome Measure Information:
Title
The change of the nausea scores
Description
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)
Time Frame
During postoperative 24 hours
Title
The change of the vomiting score
Description
Vomiting will be measured with verbal descriptive scale (0=no vomiting, 1= 1 time, 2= 2 or 3 times, 3= 4 times and up)
Time Frame
During postoperative 24 hours
Secondary Outcome Measure Information:
Title
The consumption of the antiemetic drug
Description
The antiemetic drug dose will be recorded
Time Frame
During postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tugba Karaman, MD
Organizational Affiliation
Gaziosmanpasa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziosmanpasa University Medical School Hospital
City
Tokat
ZIP/Postal Code
60100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Aromatherapy on Postoperative Nausea, Vomiting
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