Postoperative Nausea and VomitingNCT04874298
The Effect of Ginger and Peppermint on Postoperative Nausea and Vomiting in Patients After Thyroid Surgery
A study testing Ginger and Peppermint in people with Postoperative Nausea and Vomiting, run by Sona PASHAEI at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Ginger and Peppermint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
IU-Cerrahpaşa Florence Nightingale Faculty of Nursing Department of Surgical Nursing Abide-i Hürriyet street. 34381 Sisli - Istanbul
Istanbul
Sona PASHAEI, MSC, +905374869720, sona.pashaei@ogr.iu.edu.tr
Nuray AKYUZ, Dr, +905326256188, nakyuz1@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Ginger, Peppermint
- Keywords
- Nausea, Vomiting, Postoperative Nausea and Vomiting, Ginger, Peppermint, Thyroid surgery, Nursing
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerOther
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.
PeppermintOther
Peppermint
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm 1 (Ginger Group) | Experimental | 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. Receives: Other: Ginger |
| Intervention Arm 2 (Peppermint Group) | Experimental | 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. Receives: Other: Peppermint |
| Control Arm | No intervention | In the control group, no application will be made during and after the surgical intervention, and routine treatment and care will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain severity
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Measured: Reported pain severity in the first 24 hours after surgery
The number of postoperative nausea, vomiting and retching
The number of nausea, vomiting
Measured: Reported the number of nausea, vomiting and retching in the first 24 hours after surgery
Postoperative nausea and vomiting severity
Nausea and vomiting severity with Visual Assessment Scale (VAS) Score: 0-10; 0- None, 10- Agonizing
Measured: Reported nausea and vomiting severity in the first 24 hours after surgery
Use of antiemetics
The name, dose, frequency and time of the antiemetic drugs
Measured: In the first 24 hours after surgery
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.
Measured: At the end of the 24th hour after surgery
Secondary outcomes (1)
Postoperative complications
Evaluation of postoperative complications
Measured: End of surgery to hospital discharge 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Mar 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sona PASHAEI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sona PASHAEI, Istanbul University - Cerrahpasa
- Investigators
- Yeliz E Ersoy, Prof.Dr, Principal investigator, Bezmialem UniversityNuray AKYUZ, Dr, Study director, Istanbul University - CerrahpasaSona PASHAEI, MSC, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874298
- Sponsor's protocol ID
- 2020-8-1
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ginger and Peppermint on Postoperative Nausea and Vomiting in Patients After Thyroid Surgery
- ClinicalTrials.gov ID
- NCT04874298
- Acronym / sponsor ID
- 2020-8-1
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Nausea, Vomiting, Postoperative Nausea and Vomiting, Ginger, Peppermint, Thyroid surgery, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Sona PASHAEIUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized controlled experimental study to determine the effect of ginger and peppermint after thyroid surgery on postoperative nausea and vomiting
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm 1 (Ginger Group) | Experimental | Other: GingerPatients 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. |
| Intervention Arm 2 (Peppermint Group) | Experimental | Other: PeppermintPatients 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. |
| Control Arm | No intervention | –In the control group, no application will be made during and after the surgical intervention, and routine treatment and care will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GingerPatients 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. | Other | Intervention Arm 1 (Ginger Group) |
| PeppermintPeppermint | Other | Intervention Arm 2 (Peppermint Group) |
Primary outcome
Postoperative pain severity
Time frame: Reported pain severity in the first 24 hours after surgery
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
Time frame: Reported the number of nausea, vomiting and retching in the first 24 hours after surgery
The number of nausea, vomiting
Postoperative nausea and vomiting severity
Time frame: Reported nausea and vomiting severity in the first 24 hours after surgery
Nausea and vomiting severity with Visual Assessment Scale (VAS) Score: 0-10; 0- None, 10- Agonizing
Use of antiemetics
Time frame: In the first 24 hours after surgery
The name, dose, frequency and time of the antiemetic drugs
Rhodes Nausea Vomiting Index score
Time frame: At the end of the 24th hour after surgery
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.
1 secondary outcome
Postoperative complications
Time frame: End of surgery to hospital discharge 2-3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeliz E Ersoy, Prof.Dr principal investigator
Bezmialem University
Nuray AKYUZ, Dr study director
Istanbul University - Cerrahpasa
Sona PASHAEI, MSC study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginger and Peppermint in people with Postoperative Nausea and Vomiting, run by Sona PASHAEI at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sona PASHAEI, MSC (+905374869720, sona.pashaei@ogr.iu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain severity (time frame: Reported pain severity in the first 24 hours after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.