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Completed

NCT Number: NCT05679531

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

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Hospitalism in Children Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Uludag University

Bursa, 16330, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Other

After filling out the patient information form, the patients who met the research criteria were chewed gum for an average of 15 minutes.

Primary outcomes

  1. 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.

  2. 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)

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ruya Naz

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2023
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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