Clinical trial NCT06603025: Preoperative Chewing Gum on Anxiety and Postoperative Nausea and Vomiting, Gastrointestinal Function
Official title: Investigation of the Effect of Preoperative Gum Chewing on Anxiety, Gastrointestinal Function, Nausea and Vomiting in Patients Undergoing Abdominal Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gum Chewing
Preoperative
Anxiety
Postoperative Nausea and Vomiting
Keywords: Chewing Gum
Abdomen/surgery,
Postoperative Complications
Gastrointestinal Function
Ileus
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective randomized controlled trial with experimental and control groups
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: the preoperative anxiety
timeFrame: before entering OR
Secondary outcomes:
measure: abdominal distantion
timeFrame: 1 day after surgery. after surgery, the patient will be evaluated every 4 hours up to 48-72 hours after surgery
measure: nausea, vomiting
timeFrame: 1 day after surgery. The patient will be asked every 4 hours whether they have nausea/vomiting up to 48-72 hours after surgery
measure: Time to first flatus
timeFrame: after surgery until the first flatus up to 48-72 hours
measure: Time to first bowel movement
timeFrame: after surgery until the first bowel movements up to 48-72 hours
measure: first defecation time
timeFrame: after surgery until the patients defecation time up to 48-72 hours
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
state: North Cyprus via Mersin
Study officials:
References:
citation: 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.