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

Sponsor
Ruya Naz (Other)
Overall Status
Completed
CT.gov ID
NCT05679531
Collaborator
(none)
60
1
2
2
29.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effects of Menthol Gum Chewıng on Postoperatıve Nausea, Vomiting, and Length Of Hospital Stay in Children Undergoing Appendectomy: A Randomızed Controlled Trıal
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Baxter Retching Faces Scale (BARF) [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.

  2. Baxter Retching Faces Scale (BARF) [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)

  3. Baxter Retching Faces Scale (BARF) [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

  4. Baxter Retching Faces Scale (BARF) [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

  5. Baxter Retching Faces Scale (BARF) [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

Secondary Outcome Measures

  1. length of hospitalization [Up to 2 week]

    The time from the date of hospitalization to the date of discharge was calculated, Up to 2 week

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bursa Uludag University Bursa Turkey 16330

Sponsors and Collaborators

  • Ruya Naz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruya Naz, Nurse, Uludag University
ClinicalTrials.gov Identifier:
NCT05679531
Other Study ID Numbers:
  • RNaz
First Posted:
Jan 11, 2023
Last Update Posted:
Jan 12, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ruya Naz, Nurse, Uludag University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2023