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

NCT06603025 | Active Not Recruiting

• 1 other identifier: GSD-2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Gum Chewing; Preoperative; Anxiety; Postoperative Nausea and Vomiting

Keywords

Chewing Gum; Abdomen/surgery,; Postoperative Complications; Gastrointestinal Function; Ileus

Outcome Measures

Primary Outcomes (1)

• the preoperative anxiety

  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 Outcomes (5)

• abdominal distantion

  1 day after surgery. after surgery, the patient will be evaluated every 4 hours up to 48-72 hours after surgery

• 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

• Time to first flatus

  after surgery until the first flatus up to 48-72 hours

• Time to first bowel movement

  after surgery until the first bowel movements up to 48-72 hours

• first defecation time

  after surgery until the patients defecation time up to 48-72 hours

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

standard care (no chewing gum)

Interventions

chewing gum OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• emergency surgery

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Famagusta, North Cyprus Via Mersin, 99628, Cyprus

Location

Related Publications (1)

• Bang YJ, Lee JH, Kim CS, Lee YY, Min JJ. Anxiolytic effects of chewing gum during preoperative fasting and patient-centered outcome in female patients undergoing elective gynecologic surgery: randomized controlled study. Sci Rep. 2022 Mar 9;12(1):4165. doi: 10.1038/s41598-022-07942-6.

  PMID: 35264684 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Anxiety Disorders; Postoperative Nausea and Vomiting; Postoperative Complications; Ileus

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will not know which group the intervention is for. Data entry will be made as A and B.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Dr

Model Details: prospective randomized controlled trial with experimental and control groups

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 19, 2024
• Study Start: September 6, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)