- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04874298
The Effect of Ginger and Peppermint on Postoperative Nausea and Vomiting in Patients After Thyroid Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The universe of the research; patients who are planned to undergo thyroid surgery between 1 December 2020 and 1 December 2021 in the general surgery clinic where the study will be conducted will comprise the patients who meet the inclusion criteria and agree to participate in the study. The research was planned as a randomized controlled experimental study. Block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Research data will be collected in a hospital's general surgery ward between 1 December 2020 and 1 December 2021.
Independent variables of the research; age, gender, educational status, marital status, height, weight, habits and general health parameters were defined as independent variables. The dependent variables of the study are postoperative nausea-vomiting status (number and severity), pain severity (Visual Analog Scale-VAS), and Rhodes nausea-vomiting index score average.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sona PASHAEI, MSC
- Phone Number: +905374869720
- Email: sona.pashaei@ogr.iu.edu.tr
Study Contact Backup
- Name: Nuray AKYUZ, Dr
- Phone Number: +905326256188
- Email: nakyuz1@hotmail.com
Study Locations
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Istanbul, Turkey
- Recruiting
- IU-Cerrahpaşa Florence Nightingale Faculty of Nursing Department of Surgical Nursing Abide-i Hürriyet street. 34381 Sisli - Istanbul
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Contact:
- Sona PASHAEI, MSC
- Phone Number: +905374869720
- Email: sona.pashaei@ogr.iu.edu.tr
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Contact:
- Nuray AKYUZ, Dr
- Phone Number: +905326256188
- Email: nakyuz1@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Those who are 18 years old or older,
- According to the American Association of Anesthesiologists (ASA) classification; ASA score I and II,
- Not known ginger and peppermint allergy,
- Patients who are qualified to understand and answer questions in terms of cognitive capacity,
- Patients without any psychiatric disorder,
- Patients who agree to participate in the study will be included in the study.
Exclusion Criteria:
- Under 18 years old,
- Those with nutritional disorders,
- Patients who require additional treatment to prevent nausea and vomiting, or patients using non-prescription anti-nausea and other complementary therapy,
- Patients with peppermint and ginger allergy,
- Those who have additional diseases (gastrointestinal system diseases, central nervous system tumors, vertigo etc.) that may affect the state of nausea and vomiting,
- Not agreeing to participate in the research,
- Those with respiratory diseases such as asthma, COPD, etc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Arm
In the control group, no application will be made during and after the surgical intervention, and routine treatment and care will be applied.
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Experimental: Intervention Arm 1 (Ginger Group)
Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental group.
In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use ginger oil as inhalation.
The structure of the inhaler tube is explained.
The back cover of the inhaler tube is opened and absorbent cotton swab is inserted into it.
Cotton swab 1 ml of essential oil is added by dropping on it.
The back cover of the inhaler tube is closed.
It is waited for 10-15 minutes.
The front cover of the inhaler tube is opened at the time intervals specified in the study procedure (at the 2nd, 4th, 6th, 12th and 24th hours after the operation, and the patient is allowed to smell essential oil from the tube.
With the end of the sniffing process, the front cover of the tube is closed and the essential oil remains in the tube.
The essential oil tubes to be applied will be prepared separately for each patient and that day.
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Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental group.
In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use Ginger and Peppermint oil as inhalation.
The structure of the inhaler tube is explained.
The back cover of the inhaler tube is opened and absorbent cotton swab is inserted into it.
Cotton swab 1 ml of essential oil is added by dropping on it.
The back cover of the inhaler tube is closed.
It is waited for 10-15 minutes.
The front cover of the inhaler tube is opened at the time intervals specified in the study procedure (at the 2nd, 4th, 6th, 12th and 24th hours after the operation, and the patient is allowed to smell essential oil from the tube.
With the end of the sniffing process, the front cover of the tube is closed and the essential oil remains in the tube.
The essential oil tubes to be applied will be prepared separately for each patient and that day.
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Experimental: Intervention Arm 2 (Peppermint Group)
Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental group.
In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use Peppermint oil as inhalation.
The structure of the inhaler tube is explained.
The back cover of the inhaler tube is opened and absorbent cotton swab is inserted into it.
Cotton swab 1 ml of essential oil is added by dropping on it.
The back cover of the inhaler tube is closed.
It is waited for 10-15 minutes.
The front cover of the inhaler tube is opened at the time intervals specified in the study procedure (at the 2nd, 4th, 6th, 12th and 24th hours after the operation, and the patient is allowed to smell essential oil from the tube.
With the end of the sniffing process, the front cover of the tube is closed and the essential oil remains in the tube.
The essential oil tubes to be applied will be prepared separately for each patient and that day.
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Peppermint
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain severity
Time Frame: Reported pain severity in the first 24 hours after surgery
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Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
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Reported pain severity in the first 24 hours after surgery
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Postoperative nausea and vomiting severity
Time Frame: Reported nausea and vomiting severity in the first 24 hours after surgery
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Nausea and vomiting severity with Visual Assessment Scale (VAS) Score: 0-10; 0- None, 10- Agonizing
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Reported nausea and vomiting severity in the first 24 hours after surgery
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Use of antiemetics
Time Frame: In the first 24 hours after surgery
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The name, dose, frequency and time of the antiemetic drugs
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In the first 24 hours after surgery
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The number of postoperative nausea, vomiting and retching
Time Frame: Reported the number of nausea, vomiting and retching in the first 24 hours after surgery
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The number of nausea, vomiting
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Reported the number of nausea, vomiting and retching in the first 24 hours after surgery
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Rhodes Nausea Vomiting Index score
Time Frame: At the end of the 24th hour after surgery
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Evaluation of Rhodes Nausea Vomiting Index score In order to score the scale, responses to items 1, 3, 6 and 7 are calculated in reverse order; For each answer, they are scored as 0: minimum, 4: most discomfort, and the score obtained from 8 items is added.
It is expressed as 32 points, the highest possible value.
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At the end of the 24th hour after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complications
Time Frame: End of surgery to hospital discharge 2-3 days
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Evaluation of postoperative complications
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End of surgery to hospital discharge 2-3 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yeliz E Ersoy, Prof.Dr, Bezmialem University
- Study Director: Nuray AKYUZ, Dr, Istanbul University - Cerrahpasa (IUC)
- Study Chair: Sona PASHAEI, MSC, Istanbul University - Cerrahpasa (IUC)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-8-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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