NCT05990140

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

July 19, 2023

Last Update Submit

August 10, 2023

Conditions

Keywords

nausea-vomitinganxietynurseBiochemical Parameters

Outcome Measures

Primary Outcomes (3)

  • 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

    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).

    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.

    up to 1 month

Study Arms (2)

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.

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.

Interventions

The Effect of Peppermint Flavored Mouthwash Applied to Patients in the First 30 Days After Bariatric Surgery on Nausea-Vomiting, Anxiety and Biochemical Parameters

Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be between the ages of 18-65
  • Having had bariatric surgery
  • Absence of communication barriers
  • Volunteering to participate in research
  • Mental well-being

You may not qualify if:

  • Presence of major depression or psychosis
  • Having a communication barrier
  • Being transferred to another unit
  • Leaving work voluntarily

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative ComplicationsAnxiety Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Vesile Eskici İlgin, Dr

    Ataturk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vesile Eskici İlgin, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 14, 2023

Study Start

August 15, 2023

Primary Completion

May 12, 2024

Study Completion

July 15, 2024

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share