Effects of Menthol Gum Chewıng on Postoperatıve Nausea, Vomiting, and Length Of Hospital Stay in Children Undergoing Appendectomy: A Randomızed Controlled Trıal

January 10, 2023 updated by: Ruya Naz
The study was conducted as an experimental study to determine the effect of menthol chewing gum application on postoperative nausea, vomiting and hospital stay in children with appendectomy. The population of the study consisted of children aged 7-18 who underwent appendectomy in Bursa Yüksek İhtisas Training and Research Hospital Pediatric Surgery clinic between April and June 2022. In the sample of the study, a total of 60 children (menthol gum group- intervention group=30, control=30) who had postoperative nausea-vomiting, accepted to participate in the study and met the sample selection criteria were included. Starting from the second hour after the child was brought to the clinic after appendectomy, the children in the chewing gum group with nausea and vomiting were chewed gum for an average of 15 minutes. The patients in the study group were not intervened except for routine nursing care. During the chewing gum (between 5-10. minutes), up to 30., 60. and 120. Minutes after the chewing gum.The patient was re-evaluated in terms of nausea with the BARF nausea scale. Episodes of vomiting were recorded in patients with vomiting. After the quantitative stages of the study were completed, the patient's level of relief was evaluated using a verbal descriptive scale. Nausea and vomiting were also evaluated before the patient was discharged.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16330
        • Bursa Uludag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child and parent's willingness to participate in the research
  • The child has no intellectual disability or perception problems.
  • Patients who underwent general anesthesia
  • Patients who do not develop postoperative complications
  • Patients in the 7-18 age group
  • Patients who can tolerate chewing gum in the postoperative period
  • Patients who like to chew gum
  • Patients with nausea and vomiting

Exclusion Criteria:

  • Patients with a diagnosis of diabetes
  • Patients with teeth and jaw problems
  • Patients with menthol allergy
  • Patients with irritable bowel syndrome
  • Patients with a history of reflux
  • Patients whose cognitive level is not suitable
  • Patients with a nasogastric tube

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Children in the control group, who met the research criteria, were not applied any procedure other than clinical routine protocol and nursing care. After being brought to the pediatric surgery service, patients with nausea and vomiting were filled out with a questionnaire. The severity of nausea was evaluated with the BARF Scale during nausea and vomiting and 30, 60 and 120 minutes after nausea and vomiting in patients with nausea and vomiting.
Experimental: Chewing gum group
Starting from the second hour after the child was brought to the clinic after appendectomy, menthol sugar free gum was given to children with nausea and vomiting outside the clinical routine nursing care, as soon as they could chew gum and follow the instructions, and were asked to chew for an average of 15 minutes. The product of a single brand of gum was used. In the first stage, the patient's nausea was evaluated with the BARF nausea scale before the intervention. After filling out the patient information form, the patients who met the research criteria were chewed gum for an average of 15 minutes. During the intervention (between 5-10 minutes), the patient was re-evaluated for nausea with the BARF nausea scale at 30.,60. and 120 minutes after the intervention. Episodes of vomiting were recorded in patients with vomiting.After the quantitative stages of the study were completed, the patient's level of relief was evaluated using a verbal descriptive scale.
Other: intervention
After filling out the patient information form, the patients who met the research criteria were chewed gum for an average of 15 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baxter Retching Faces Scale (BARF)
Time Frame: Pre-procedure (< 1 minute)
The BARF scale was used to assess the severity of nausea. The primary outcome was nausea and vomiting as assessed by the BARF scale, which is used to measure the severity of postoperative nausea in children. The BARF scale consists of six faces and there is a difference of 2 points between each face. The Baxter Retching Faces (BARF) scale is graded from 0 to 10 points. Evaluation: 1 minute before chewing gum.
Pre-procedure (< 1 minute)
Baxter Retching Faces Scale (BARF)
Time Frame: During the procedure fifth Minute
The BARF scale was used to assess the severity of nausea. The primary outcome was nausea and vomiting as assessed by the BARF scale, which is used to measure the severity of postoperative nausea in children. The BARF scale consists of six faces and there is a difference of 2 points between each face. The Baxter Retching Faces (BARF) scale is graded from 0 to 10 points. Evaluation: During chewing gum ( fifth minute)
During the procedure fifth Minute
Baxter Retching Faces Scale (BARF)
Time Frame: after menthol chewing gum 30 minutes
The BARF scale was used to assess the severity of nausea. The primary outcome was nausea and vomiting as assessed by the BARF scale, which is used to measure the severity of postoperative nausea in children. The BARF scale consists of six faces and there is a difference of 2 points between each face. The Baxter Retching Faces (BARF) scale is graded from 0 to 10 points. Evaluation: 30 minutes after menthol chewing gum
after menthol chewing gum 30 minutes
Baxter Retching Faces Scale (BARF)
Time Frame: after menthol chewing gum 60 minutes)
The BARF scale was used to assess the severity of nausea. The primary outcome was nausea and vomiting as assessed by the BARF scale, which is used to measure the severity of postoperative nausea in children. The BARF scale consists of six faces and there is a difference of 2 points between each face. The Baxter Retching Faces (BARF) scale is graded from 0 to 10 points. Evaluation: 60 minutes after menthol chewing gum
after menthol chewing gum 60 minutes)
Baxter Retching Faces Scale (BARF)
Time Frame: after menthol chewing gum (120 minutes)
The BARF scale was used to assess the severity of nausea. The primary outcome was nausea and vomiting as assessed by the BARF scale, which is used to measure the severity of postoperative nausea in children. The BARF scale consists of six faces and there is a difference of 2 points between each face. The Baxter Retching Faces (BARF) scale is graded from 0 to 10 points. Evaluation: 120 minutes after menthol chewing gum
after menthol chewing gum (120 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
length of hospitalization
Time Frame: Up to 2 week
The time from the date of hospitalization to the date of discharge was calculated, Up to 2 week
Up to 2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruya Naz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNaz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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