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

February 25, 2025 updated by: Gülten Sucu Dağ, Eastern Mediterranean University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
    • North Cyprus via Mersin
      • Famagusta, North Cyprus via Mersin, Cyprus, 99628
        • Eastern Mediterranean University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
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.
No Intervention: Control group
standard care (no chewing gum)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the preoperative anxiety
Time Frame: 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).
before entering OR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
abdominal distantion
Time Frame: 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.
1 day after surgery. after surgery, the patient will be evaluated every 4 hours up to 48-72 hours after surgery
nausea, vomiting
Time Frame: 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.
1 day after surgery. The patient will be asked every 4 hours whether they have nausea/vomiting up to 48-72 hours after surgery
Time to first flatus
Time Frame: 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.
after surgery until the first flatus up to 48-72 hours
Time to first bowel movement
Time Frame: 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
after surgery until the first bowel movements up to 48-72 hours
first defecation time
Time Frame: 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.
after surgery until the patients defecation time up to 48-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Mediterranean University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSD-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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