NCT06603025

Preoperative Chewing Gum on Anxiety and Postoperative Nausea and Vomiting, Gastrointestinal Function

Investigation of the Effect of Preoperative Gum Chewing on Anxiety, Gastrointestinal Function, Nausea and Vomiting in Patients Undergoing Abdominal Surgery: A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Eastern Mediterranean University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this study was to investigate the effects of chewing gum before surgery on preoperative anxiety, postoperative gastrointestinal functions (time to first gas, time to first defecation, bowel sounds, abdominal distension) and nausea and vomiting in patients undergoing abdominal surgery. Hypotheses of the Study: In patients undergoing abdominal surgery; H1.1: The first gas output time (hour) is shorter in patients who chew gum before surgery compared to patients who do not chew gum H1.2: The first defecation time (hour) is shorter in patients who chew gum before surgery compared to patients who do not chew gum H1.3: The bowel sounds are heard shorter in patients who chew gum before surgery compared to patients who do not chew gum H1.4: The abdominal distension rate is lower in patients who chew gum before surgery compared to patients who do not chew gum H1.5: The nausea and vomiting rate is lower in patients who chew gum before surgery compared to patients who do not chew gum H1.6: Preoperative anxiety levels of patients who chew gum before surgery are lower than those of patients who do not chew gum Preoperative intervention group patients will chew sugarless gum for at least 30 minutes 30-60 minutes before surgery. The gum will be removed before going to the operating room. No intervention will be performed on control group patients, and standard care will be applied.

Detailed description

The aim of this study was to investigate the effects of chewing gum before surgery on preoperative anxiety, postoperative gastrointestinal functions (time to first gas, time to first defecation, bowel sounds, abdominal distension) and nausea and vomiting in patients undergoing abdominal surgery. This study will be conducted as a single-center prospective randomized controlled trial in accordance with the principles of the Declaration of Helsinki. The study will be conducted in a private hospital in the Gazimağusa region on patients who will undergo abdominal surgery. Preoperative intervention group patients will chew sugarless gum for at least 30 minutes 30-60 minutes before surgery. The gum will be removed before going to the operating room. No intervention will be performed on control group patients, and standard care will be applied. Sample inclusion criteria * Patients with ASA scores I and II (ASA Physical Status Classification System) * Patients with BMI \< 30 (kg/m2) * Patients over the age of 18 who will undergo abdominal surgery * Patients who have the ability to read and understand the research instructions * Patients who agree to participate in the research Sampling exclusion criteria * Patients who do not accept chewing gum The number of samples to be included in the study was calculated by taking into account the median values of the first gas outlet time in the study of Bang et al. (2022). Accordingly, the median values of the first gas outlet time were 26.4 \[15.2-39.2\] hours in the control group and 20.6 \[16.8-38.9\] hours in the experimental group (Bang et al. 2022). Accordingly, it was planned to include a total of 70 patients, with an effect size of d = 0.70, a margin of error of α = 0.05, and a power of 80%, with a required sample size of 35 in each group. Considering that there may be missing data, it was decided to increase the sample size by 10% and include 39 patients in each group, making a total of 78 patients. The time to first gas discharge after surgery, the time to first defecation, the duration of hospital stay, the frequency of nausea, vomiting and abdominal distension, the time and number of bowel sounds heard, and the need for antiemetic medication after surgery will be recorded in the experimental and control groups.

Conditions

• Gum Chewing
• Preoperative
• Anxiety
• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
OTHER	chewing gum	Preoperative intervention group patients will chew sugarless gum for at least 30 minutes 30-60 minutes before surgery. The gum will be removed before going to the operating room.

Timeline

• Start date: 2024-09-06
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2024-09-19
• Last updated: 2025-02-26

Locations

1 site across 1 country: Cyprus