Postoperative ComplicationsNCT05990140
The Effect of Peppermint Flavored Mouthwash Applied to Patients
A study testing peppermint flavored mouthwash in people with Postoperative Complications, run by Ataturk University.
Trial summary
Treatment of obesity consists of diet/lifestyle modification and bariatric surgery consisting of several procedures. One of the most common complications in the early period after bariatric surgery is nausea and vomiting due to the reduction of gastric capacity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- peppermint flavored mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2023to 15 Jul 2024
- 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
- Be between the ages of 18-65
- Having had bariatric surgery
- Absence of communication barriers
- Volunteering to participate in research
- Mental well-being
Who cannot join
- Presence of major depression or psychosis
- Having a communication barrier
- Being transferred to another unit
- Leaving work voluntarily
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Peppermint Flavored Mouthwash Applied to Patients in the First 30 Days After Bariatric Surgery on Nausea-Vomiting, Anxiety and Biochemical Parameters
Treatment of obesity consists of diet/lifestyle modification and bariatric surgery consisting of several procedures. One of the most common complications in the early period after bariatric surgery is nausea and vomiting due to the reduction of gastric capacity. According to the guidelines of the American Society of Metabolic and Bariatric Surgery (ASMBS), acid-base disorders, electrolyte abnormalities (especially calcium, potassium, magnesium, sodium and phosphorus deficiency), insufficiency of fat-soluble vitamins (ADEK), folic acid, iron, thiamine after bariatric surgery. and B12 deficiency etc. On the other hand, anxiety after bariatric surgery is also an important problem.
It is possible to reduce nausea and vomiting by stimulating the vagal nerve. Gargling, laughing, singing loudly, etc. The movements stimulate the vagus nerve by activating the muscles behind the larynx, and the vagus nerve prevents nausea and vomiting by simulating the gastrointestinal tract. With the activation of the diaphragm; The vagus nerve is stimulated, the parasympathetic nervous system is activated and cortisol production decreases, reducing stress and anxiety. The peppermint plant, which is widely used in our country, is also used as a relief in cases such as nausea, stomachache, and colds. It is expected that the nurse, who is a member of the multidisciplinary team, will be able to properly define the surgical risks and comorbidities associated with the clinical status of obesity in patients who have undergone bariatric surgery and to apply the necessary interventions.
- Conditions
- Postoperative Complications
- Being tested
- peppermint flavored mouthwash
- Keywords
- nausea-vomiting, anxiety, nurse, Biochemical Parameters
- Medical subject headings
- Postoperative Complications, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peppermint flavored mouthwashOther
The Effect of Peppermint Flavored Mouthwash Applied to Patients in the First 30 Days After Bariatric Surgery on Nausea-Vomiting, Anxiety and Biochemical Parameters
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Consent of all patients will be obtained the night before surgery. Biochemical parameter levels and state trait anxiety scale and apfel risk scale will be recorded.
As it will be difficult for the experimental group to be oriented while giving mouthwash training after the surgery, mouthwash training will be given at a time when it is available the night before the operation. State anxiety scale, visual comparison scale and nausea and vomiting effect scale will be administered before discharge (approximately 48 hours). After discharge, he will continue to gargle in the same way 3 times a day. At the end of the first week, all patients will be called by the researcher and the state anxiety scale, visual comparison scale and nausea and vomiting effect scale shared on the digital environment will be filled and recorded. This process will continue for 4 weeks. In the last measurement, visual comparison scale, nausea vomiting and state trait anxiety scale will also be filled. Receives: Other: peppermint flavored mouthwash |
| Control | No intervention | Consent of all patients will be obtained the night before surgery. Biochemical parameter levels and state trait anxiety scale and apfel risk scale will be recorded. The state anxiety scale, visual comparison scale and nausea and vomiting effect scale will be administered to the control group before they are discharged (approximately at the 48th hour). At the end of the first week, all patients will be called by the researcher, and the state anxiety scale, visual comparison scale and nausea and vomiting effect scale will be filled and recorded. This process will continue for 4 weeks. In the last measurement, visual comparison scale, nausea vomiting and state trait anxiety scale will also be filled. At the end of the first month, the biochemical parameters taken during the routine hospital control will be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory
This inventory consists of two separate sections. consists of 40 questions in total. General temperament of the person in 20 questions in the continuous section While the state is evaluated, how the person feels at that moment is evaluated in the state section. Continually Anxiety is an individual's tendency to experience anxiety. State anxiety is the stressful situation in which the individual is It is the subjective fear felt by the situation. While it rises when the stress is intense, the stress In cases where the level of anxiety decreases, the State-Trait Anxiety Inventory score decreases. Inventory While filling, one of the 4 options is preferred; scores are added together and high scores are shows anxiety levels
Measured: up to 1 month
Nausea Vomiting Visual Comparison Scale
It is a scale that evaluates the severity of nausea of the participants on a 10-centimeter ruler with "0" on the left end, no nausea at all, and "100" on the right end as the most severe nausea (unbearable nausea).
Measured: up to 1 month
Determination of Levels of Biochemical Parameters in Blood
Laboratory results obtained routinely in the hospital where the study will be conducted will be used.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Aug 2023 (estimated)
- Primary completion12 May 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesile Eskici Ilgin, Ataturk University
- Investigators
- Vesile Eskici İlgin, Dr, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990140
- Sponsor's protocol ID
- Vesile23
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peppermint Flavored Mouthwash Applied to Patients in the First 30 Days After Bariatric Surgery on Nausea-Vomiting, Anxiety and Biochemical Parameters
- ClinicalTrials.gov ID
- NCT05990140
- Acronym / sponsor ID
- Vesile23
- Conditions
- Postoperative Complications
- Keywords
- nausea-vomiting, anxiety, nurse, Biochemical Parameters
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 12 May 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
Treatment of obesity consists of diet/lifestyle modification and bariatric surgery consisting of several procedures. One of the most common complications in the early period after bariatric surgery is nausea and vomiting due to the reduction of gastric capacity. According to the guidelines of the American Society of Metabolic and Bariatric Surgery (ASMBS), acid-base disorders, electrolyte abnormalities (especially calcium, potassium, magnesium, sodium and phosphorus deficiency), insufficiency of fat-soluble vitamins (ADEK), folic acid, iron, thiamine after bariatric surgery. and B12 deficiency etc. On the other hand, anxiety after bariatric surgery is also an important problem.
It is possible to reduce nausea and vomiting by stimulating the vagal nerve. Gargling, laughing, singing loudly, etc. The movements stimulate the vagus nerve by activating the muscles behind the larynx, and the vagus nerve prevents nausea and vomiting by simulating the gastrointestinal tract. With the activation of the diaphragm; The vagus nerve is stimulated, the parasympathetic nervous system is activated and cortisol production decreases, reducing stress and anxiety. The peppermint plant, which is widely used in our country, is also used as a relief in cases such as nausea, stomachache, and colds. It is expected that the nurse, who is a member of the multidisciplinary team, will be able to properly define the surgical risks and comorbidities associated with the clinical status of obesity in patients who have undergone bariatric surgery and to apply the necessary interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: peppermint flavored mouthwashConsent of all patients will be obtained the night before surgery. Biochemical parameter levels and state trait anxiety scale and apfel risk scale will be recorded. As it will be difficult for the experimental group to be oriented while giving mouthwash training after the surgery, mouthwash training will be given at a time when it is available the night before the operation. State anxiety scale, visual comparison scale and nausea and vomiting effect scale will be administered before discharge (approximately 48 hours). After discharge, he will continue to gargle in the same way 3 times a day. At the end of the first week, all patients will be called by the researcher and the state anxiety scale, visual comparison scale and nausea and vomiting effect scale shared on the digital environment will be filled and recorded. This process will continue for 4 weeks. In the last measurement, visual comparison scale, nausea vomiting and state trait anxiety scale will also be filled. |
| Control | No intervention | –Consent of all patients will be obtained the night before surgery. Biochemical parameter levels and state trait anxiety scale and apfel risk scale will be recorded. The state anxiety scale, visual comparison scale and nausea and vomiting effect scale will be administered to the control group before they are discharged (approximately at the 48th hour). At the end of the first week, all patients will be called by the researcher, and the state anxiety scale, visual comparison scale and nausea and vomiting effect scale will be filled and recorded. This process will continue for 4 weeks. In the last measurement, visual comparison scale, nausea vomiting and state trait anxiety scale will also be filled. At the end of the first month, the biochemical parameters taken during the routine hospital control will be recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be between the ages of 18-65
- Having had bariatric surgery
- Absence of communication barriers
- Volunteering to participate in research
- Mental well-being
Key exclusion criteria (4 listed)
- Presence of major depression or psychosis
- Having a communication barrier
- Being transferred to another unit
- Leaving work voluntarily
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 |
|---|---|---|
| peppermint flavored mouthwashThe Effect of Peppermint Flavored Mouthwash Applied to Patients in the First 30 Days After Bariatric Surgery on Nausea-Vomiting, Anxiety and Biochemical Parameters | Other | Experimental |
Primary outcome
State-Trait Anxiety Inventory
Time frame: up to 1 month
This inventory consists of two separate sections. consists of 40 questions in total. General temperament of the person in 20 questions in the continuous section While the state is evaluated, how the person feels at that moment is evaluated in the state section. Continually Anxiety is an individual's tendency to experience anxiety. State anxiety is the stressful situation in which the individual is It is the subjective fear felt by the situation. While it rises when the stress is intense, the stress In cases where the level of anxiety decreases, the State-Trait Anxiety Inventory score decreases. Inventory While filling, one of the 4 options is preferred; scores are added together and high scores are shows anxiety levels
Nausea Vomiting Visual Comparison Scale
Time frame: up to 1 month
It is a scale that evaluates the severity of nausea of the participants on a 10-centimeter ruler with "0" on the left end, no nausea at all, and "100" on the right end as the most severe nausea (unbearable nausea).
Determination of Levels of Biochemical Parameters in Blood
Time frame: up to 1 month
Laboratory results obtained routinely in the hospital where the study will be conducted will be used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Vesile Eskici İlgin, Dr principal investigator
Ataturk University
Questions about this trial
What is this clinical trial studying?
A study testing peppermint flavored mouthwash in people with Postoperative Complications, run by Ataturk University.
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 5 inclusion and 4 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Vesile Eskici İlgin, Dr (05057820893, vesile_eskici_86@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (time frame: up to 1 month). The study lists 3 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 14 Aug 2023.