Postoperative Nausea and VomitingNCT05679531
Effects of Menthol Gum Chewıng on Postoperatıve Nausea, Vomiting, and Length Of Hospital Stay in Children Undergoing Appendectomy: A Randomızed Controlled Trıal
A study testing intervention in people with Postoperative Nausea and Vomiting and Hospitalism in Children, run by Ruya Naz at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting, Hospitalism in Children
- What is being tested?
- intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Jun 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- intervention
- Keywords
- child, appendectomy, nausea and vomiting, chewing gum, length of hospitalization
- 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.
interventionOther
After filling out the patient information form, the patients who met the research criteria were chewed gum for an average of 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Chewing gum group | Experimental | 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. Receives: Other: intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baxter Retching Faces Scale (BARF)
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.
Measured: Pre-procedure (< 1 minute)
Baxter Retching Faces Scale (BARF)
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)
Measured: During the procedure fifth Minute
Baxter Retching Faces Scale (BARF)
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
Measured: after menthol chewing gum 30 minutes
Baxter Retching Faces Scale (BARF)
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
Measured: after menthol chewing gum 60 minutes)
Baxter Retching Faces Scale (BARF)
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
Measured: after menthol chewing gum (120 minutes)
Secondary outcomes (1)
length of hospitalization
The time from the date of hospitalization to the date of discharge was calculated, Up to 2 week
Measured: Up to 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Apr 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruya Naz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruya Naz, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679531
- Sponsor's protocol ID
- RNaz
- Status last verified
- Jan 2023
- First submitted
- 8 Dec 2022
- Last updated
- 12 Jan 2023
- 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 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Menthol Gum Chewıng on Postoperatıve Nausea, Vomiting, and Length Of Hospital Stay in Children Undergoing Appendectomy: A Randomızed Controlled Trıal
- ClinicalTrials.gov ID
- NCT05679531
- Acronym / sponsor ID
- RNaz
- Keywords
- child, appendectomy, nausea and vomiting, chewing gum, length of hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ruya NazUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 11 Jan 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Chewing gum group | Experimental | Other: interventionStarting 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| interventionAfter filling out the patient information form, the patients who met the research criteria were chewed gum for an average of 15 minutes. | Other | Chewing gum group |
Primary outcome
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.
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)
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
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
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
1 secondary outcome
length of hospitalization
Time frame: Up to 2 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention in people with Postoperative Nausea and Vomiting and Hospitalism in Children, run by Ruya Naz 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 8 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: finished, as of the sponsor's last update on 12 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baxter Retching Faces Scale (BARF) (time frame: Pre-procedure (< 1 minute)). 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 12 Jan 2023.