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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05679531
• Other study ID #: RNaz
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2023
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hospitalism in Children
• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
Turkey	Bursa Uludag University	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Ruya Naz

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-procedure (< 1 minute)
Primary	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)	During the procedure fifth Minute
Primary	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	after menthol chewing gum 30 minutes
Primary	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	after menthol chewing gum 60 minutes)
Primary	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	after menthol chewing gum (120 minutes)
Secondary	length of hospitalization	The time from the date of hospitalization to the date of discharge was calculated, Up to 2 week	Up to 2 week