Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603025
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Preoperative Chewing Gum on Anxiety and Postoperative Nausea and Vomiting Gastrointestinal Function
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 H11 The first gas output time hour is shorter in patients who chew gum before surgery compared to patients who do not chew gum
H12 The first defecation time hour is shorter in patients who chew gum before surgery compared to patients who do not chew gum
H13 The bowel sounds are heard shorter in patients who chew gum before surgery compared to patients who do not chew gum H14 The abdominal distension rate is lower in patients who chew gum before surgery compared to patients who do not chew gum H15 The nausea and vomiting rate is lower in patients who chew gum before surgery compared to patients who do not chew gum H16 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
Hypotheses of the Study In patients undergoing abdominal surgery H11 The first gas output time hour is shorter in patients who chew gum before surgery compared to patients who do not chew gum
H12 The first defecation time hour is shorter in patients who chew gum before surgery compared to patients who do not chew gum
H13 The bowel sounds are heard shorter in patients who chew gum before surgery compared to patients who do not chew gum H14 The abdominal distension rate is lower in patients who chew gum before surgery compared to patients who do not chew gum H15 The nausea and vomiting rate is lower in patients who chew gum before surgery compared to patients who do not chew gum H16 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 kgm2
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 264 152-392 hours in the control group and 206 168-389 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 070 a margin of error of α 005 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
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 kgm2
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 264 152-392 hours in the control group and 206 168-389 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 070 a margin of error of α 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None