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

Not Applicable

Active, not recruiting

• Conditions: Gum Chewing; Preoperative; Anxiety; Postoperative Nausea and Vomiting
• Interventions: Other: chewing gum

• Registration Number: NCT06603025
• Lead Sponsor: Eastern Mediterranean University

Brief 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.

Study Timeline

• Study First Submitted: 2024-08-28
• Study Start: 2024-09-06
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• American Society of Anesthesiologists physical status I-II
• body mass index (BMI) < 30 (kg/m2)
• individuals undergoing abdominal surgery

Exclusion Criteria

• emergency surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention group	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.

Primary Outcome Measures

Name	Time	Method
the preoperative anxiety	before entering OR	the preoperative anxiety using APAIS immediately before entering OR. The APAIS scale consists of 6 items, and each statement is given a numerical value based on a 5-point Likert scale according to severity. These values, which vary between 1-5; 1=none, 2=mild, 3=moderate, 4=severe, 5=extremely severe. The scores on the anxiety of APAIS range from 6 (not anxious) to 30 (extremely anxious).

Secondary Outcome Measures

Name	Time	Method
abdominal distantion	1 day after surgery. after surgery, the patient will be evaluated every 4 hours up to 48-72 hours after surgery	abdominal distension (frequency). abdominal distantion will be evaluated by performing an abdominal examination every 4 hours. Abdominal distension will be evaluated as present or absent after the evaluation.
nausea, vomiting	1 day after surgery. The patient will be asked every 4 hours whether they have nausea/vomiting up to 48-72 hours after surgery	nausea and vomiting(frequency). The patient will be asked whether they have nausea/vomiting. The patients nausea and vomiting status and frequency will be recorded.
Time to first flatus	after surgery until the first flatus up to 48-72 hours	The mean time to first flatus (hours). The time to first flatus will be evaluated by asking the patient after the surgery. If there is gas discharge, it will be evaluated as yes and the time of gas discharge after the surgery will be recorded.
Time to first bowel movement	after surgery until the first bowel movements up to 48-72 hours	Time to first bowel sounds (Hours). Patients bowel movements will be examined abdominally using a stethoscope to detect the intestinal movement every 4 hours
first defecation time	after surgery until the patients defecation time up to 48-72 hours	The mean time to first defecation time (hours). The time to first defecation time will be evaluated by asking the patient after the surgery. If there is first defecation, it will be evaluated as yes and the time of first defecation after the surgery will be recorded.

Trial Locations

Locations (1)

Eastern Mediterranean University; 🇨🇾 Famagusta, North Cyprus via Mersin, Cyprus