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The Effect of Ginger and Peppermint on Postoperative Nausea and Vomiting in Patients After Thyroid Surgery

Primary Purpose

Postoperative Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ginger
Peppermint
Sponsored by
Sona PASHAEI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Nausea and Vomiting focused on measuring Nausea, Vomiting, Postoperative Nausea and Vomiting, Ginger, Peppermint, Thyroid surgery, Nursing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Those who are 18 years old or older,
  2. According to the American Association of Anesthesiologists (ASA) classification; ASA score I and II,
  3. Not known ginger and peppermint allergy,
  4. Patients who are qualified to understand and answer questions in terms of cognitive capacity,
  5. Patients without any psychiatric disorder,
  6. Patients who agree to participate in the study will be included in the study.

Exclusion Criteria:

  1. Under 18 years old,
  2. Those with nutritional disorders,
  3. Patients who require additional treatment to prevent nausea and vomiting, or patients using non-prescription anti-nausea and other complementary therapy,
  4. Patients with peppermint and ginger allergy,
  5. Those who have additional diseases (gastrointestinal system diseases, central nervous system tumors, vertigo etc.) that may affect the state of nausea and vomiting,
  6. Not agreeing to participate in the research,
  7. Those with respiratory diseases such as asthma, COPD, etc.

Sites / Locations

  • IU-Cerrahpaşa Florence Nightingale Faculty of Nursing Department of Surgical Nursing Abide-i Hürriyet street. 34381 Sisli - IstanbulRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intervention Arm 1 (Ginger Group)

Intervention Arm 2 (Peppermint Group)

Control Arm

Arm Description

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.

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.

In the control group, no application will be made during and after the surgical intervention, and routine treatment and care will be applied.

Outcomes

Primary Outcome Measures

Postoperative pain severity
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
The number of postoperative nausea, vomiting and retching
The number of nausea, vomiting
Postoperative nausea and vomiting severity
Nausea and vomiting severity with Visual Assessment Scale (VAS) Score: 0-10; 0- None, 10- Agonizing
Use of antiemetics
The name, dose, frequency and time of the antiemetic drugs
Rhodes Nausea Vomiting Index score
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.

Secondary Outcome Measures

Postoperative complications
Evaluation of postoperative complications

Full Information

First Posted
May 3, 2021
Last Updated
May 15, 2021
Sponsor
Sona PASHAEI
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1. Study Identification

Unique Protocol Identification Number
NCT04874298
Brief Title
The Effect of Ginger and Peppermint on Postoperative Nausea and Vomiting in Patients After Thyroid Surgery
Official Title
The Effect of Ginger and Peppermint on Postoperative Nausea and Vomiting in Patients After Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sona PASHAEI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study was planned as a randomized controlled experimental study to determine the effect of inhalation use of ginger and peppermint on postoperative nausea and vomiting in patients undergoing thyroidectomy surgery. After the approval of the ethics committee and institutional permission, 81 patients who applied to the general surgery clinic for thyroidectomy between 1 December 2020 and 1 December 2021 and met the inclusion criteria will be included in the study. Within the scope of the planned study, the sample size in the light of the reported academic studies was determined as effect size d = 0.40 (effect size), α = 0.05 (margin of error), 1-β = 0.90 (Power) and by using the G-power package program with the specified criteria. It was decided to recruit 81 people (27 people per 3 group). 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. Before the operation, the patient will be visited and information will be given about the purpose, content and intervention to be applied. After obtaining verbal and written permission from the patients who accepted to participate in the study, the "Informed Consent" will be filled in the "Patient Identification form. On the day of surgery, "surgical intervention information will be filled in by the researcher. In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use ginger and peppermint oil as inhalation. At the end of the 24th hour, the application will be terminated. In the control group, no application will be made during and after the surgical intervention, and routine treatment and care will be applied. After admission to the clinic of the patients in the experimental and control groups, the severity of pain, nausea and vomiting, the number of nausea-vomiting at the 2nd, 6th, 12th and 24th hours, the name, dose, frequency and time of the antiemetic drugs used were determined by the researcher. At the end of the 24th hour, Rhodes Nausea Vomiting Index score will be evaluated by the researcher.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Nausea, Vomiting, Postoperative Nausea and Vomiting, Ginger, Peppermint, Thyroid surgery, Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled experimental study to determine the effect of ginger and peppermint after thyroid surgery on postoperative nausea and vomiting
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm 1 (Ginger Group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention Arm 2 (Peppermint Group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
In the control group, no application will be made during and after the surgical intervention, and routine treatment and care will be applied.
Intervention Type
Other
Intervention Name(s)
Ginger
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Peppermint
Intervention Description
Peppermint
Primary Outcome Measure Information:
Title
Postoperative pain severity
Description
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Time Frame
Reported pain severity in the first 24 hours after surgery
Title
The number of postoperative nausea, vomiting and retching
Description
The number of nausea, vomiting
Time Frame
Reported the number of nausea, vomiting and retching in the first 24 hours after surgery
Title
Postoperative nausea and vomiting severity
Description
Nausea and vomiting severity with Visual Assessment Scale (VAS) Score: 0-10; 0- None, 10- Agonizing
Time Frame
Reported nausea and vomiting severity in the first 24 hours after surgery
Title
Use of antiemetics
Description
The name, dose, frequency and time of the antiemetic drugs
Time Frame
In the first 24 hours after surgery
Title
Rhodes Nausea Vomiting Index score
Description
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.
Time Frame
At the end of the 24th hour after surgery
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Evaluation of postoperative complications
Time Frame
End of surgery to hospital discharge 2-3 days

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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sona PASHAEI, MSC
Phone
+905374869720
Email
sona.pashaei@ogr.iu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Nuray AKYUZ, Dr
Phone
+905326256188
Email
nakyuz1@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeliz E Ersoy, Prof.Dr
Organizational Affiliation
Bezmialem University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nuray AKYUZ, Dr
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sona PASHAEI, MSC
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
IU-Cerrahpaşa Florence Nightingale Faculty of Nursing Department of Surgical Nursing Abide-i Hürriyet street. 34381 Sisli - Istanbul
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sona PASHAEI, MSC
Phone
+905374869720
Email
sona.pashaei@ogr.iu.edu.tr
First Name & Middle Initial & Last Name & Degree
Nuray AKYUZ, Dr
Phone
+905326256188
Email
nakyuz1@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Ginger and Peppermint on Postoperative Nausea and Vomiting in Patients After Thyroid Surgery

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