Gum Chewing and Abdominal Vibration: Impact on Bowel Preparation Quality and Patient Satisfaction

Colonoscopy Clinical Trial

Official title:

The Effect of Gum Chewing and Abdominal Vibration on the Quality and Satisfaction of the Patient's Bowel Preparation Before Colonoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06192394
• Other study ID #: IUC-HEM-IK-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: ibrahim kiyat
• Phone: +900 288 214 55 47
• Email: ibrahimkiyat[@]klu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Colorectal cancers are a significant global health issue, underscoring the critical importance of screening programs for early detection and effective treatment. The success of a colonoscopy is largely contingent on the quality of bowel preparation. Inadequate bowel preparation can diminish the effectiveness of a colonoscopy and lead to the oversight of lesions. Previous research has demonstrated the positive effects of diet, education, and polyethylene glycol use on bowel preparation. However, there is limited research on the impact of methods such as gum chewing and abdominal vibration. This study aims to assess the effects of gum chewing and abdominal vibration, in addition to diet and medication, on the quality of bowel preparation and patient satisfaction in the pre-colonoscopy bowel preparation process. The study employs a randomized controlled single-blind experimental design with three distinct groups: a control group, a gum chewing group, and an abdominal vibration group. Each group will be evaluated based on bowel preparation quality and patient satisfaction. Bowel preparation quality will be determined using the Boston Bowel Preparation Scale, and factors such as polyp detection, the processability of the colonoscopy, and cecal intubation time will also be assessed. Patient satisfaction levels will be evaluated by considering how satisfied patients are with the colonoscopy process, taking into account complaints before and after the procedure. The outcomes of this study will contribute to a better understanding of the impact of gum chewing and abdominal vibration on the quality of bowel preparation and patient satisfaction before colonoscopy. Identifying effective methods to enhance bowel preparation quality can elevate the standard of nursing care, contributing to a healthier society. Simultaneously, this research can improve the comfort and efficacy of the colonoscopy process for patients and enhance the effectiveness of colorectal cancer screening programs, thereby benefiting public health.

Description:

An ideal bowel preparation should have the capacity to rapidly empty the fecal load without compromising patient comfort or causing fluid-electrolyte imbalance. Various methods, such as pre-colonoscopy education, low-fiber diet, split-dose polyethylene glycol (PEG) use, and activities such as walking after PEG intake, are implemented to improve the quality of bowel preparation. There is ample scientific evidence indicating that these methods enhance bowel preparation quality. However, there are fewer studies on methods such as gum chewing and abdominal vibration application, and there is no study evaluating these two methods together. It is believed that this study will be beneficial in improving the quality of bowel preparation before colonoscopy. Chewing gum is a virtual feeding method that stimulates the cephalic-vagal reflex, promoting the secretion of gastric and intestinal hormones and increasing intestinal motility. Chewing gum has advantages such as ease of application, low cost, and no reported side effects. Therefore, the use of this method as a safe intervention is recommended. Its effectiveness in reducing postoperative ileus and hospital stay has been demonstrated in many studies. Abdominal massage and vibration applications are reported to help improve symptoms in patients with severe constipation, and especially vibration applications to the abdominal region facilitate bowel emptying by increasing gastrointestinal motility. These methods are also reported to reduce distension, increase the expulsion of feces from the intestines, reduce complaints of constipation in elderly patients, and shorten bowel emptying time. Inadequate bowel preparation can lead to the repetition of the colonoscopy procedure, negatively affecting patients' experiences and satisfaction. In addition to this, factors such as the difficulty of the bowel preparation process in patients undergoing colonoscopy, unsedated colonoscopy, long appointment dates, and insufficient pre-procedure information can also negatively impact patient satisfaction. Assessing the satisfaction of patients is recommended for a successful and high-quality colonoscopy procedure. This study is designed as a randomized controlled experimental study to determine the effects of diet and medication use, as well as gum chewing and abdominal vibration, on the quality of bowel preparation and patient satisfaction in the pre-colonoscopy bowel preparation process.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 145
• Est. completion date: December 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Individuals aged between 18 and 65 years,
• Capable of effective communication,
• Mentally healthy,
• Individuals who can comprehend and implement planned interventions before colonoscopy.

Exclusion Criteria:

• Individuals with a history of abdominal surgery,
• Those with serious illnesses that could affect the study outcomes (e.g., severe heart failure, kidney failure),
• Individuals using medications that could impact intestinal functions due to systemic diseases,
• Individuals who have not complied with the recommended interventions will not be included.

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy

Intervention

Other:
• Chewing Gum
Patients will be asked to chew xylitol gum for 20 minutes every 2 hours (17.00-19.00, 19.00-21.00, 21.00-23.00) after drinking the X-M Diet syrup prescribed the day before the colonoscopy procedure. After the enema is given on the day of the colonoscopy, they will be asked to chew gum for 20 minutes every 2 hours until one hour before the scheduled procedure time. Xylitol is a naturally occurring five-carbon sugar alcohol (C5H12O5) found in fruits and vegetables such as plums, strawberries, cauliflower, and pumpkin. It is similar in taste to sucrose but contains 40% fewer calories than other carbohydrates (1 gram of xylitol = 2.4 calories). Xylitol has positive effects on dental health and may also have beneficial impacts on other systems such as immunity, respiratory, and digestive systems. Since xylitol is not digested by human enzymes, it has a laxative effect. In the study, sugar-free gum with xylitol will be used.

Device:
• Vibration
Patients will be asked to apply abdominal vibration for 5 cycles one hour after drinking the prescribed . A vibrating massage belt will be used for vibration applications. It will be stated that patients should wear the vibration belt on the abdominal area and use it at low intensity initially. They will then be explained that they can increase or decrease the intensity according to their comfort level. When they want to change the vibration level, they will be able to adjust the level they can tolerate. The belt is primarily utilized in the fitness industry for the purpose of weight loss. The intensity of the vibration application can be gradually increased on the belt. Additionally, the belt has both automatic and manual modes. When used in automatic mode, it has an automatic shutdown feature after 10 minutes.

Other:
• Control
Patients will undergo standard bowel preparation determined by the hospital.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Classification (BBHS)	This comparison will involve the assessment of bowel preparation quality for all groups, including the control group, using the Boston Bowel Preparation Scale (BBPS). BBPS developed in 2009, is used to assess the quality of bowel preparation. When BBPS is employed, each segment of the colon (left, transverse, and right) is scored based on the cleanliness degree. Each segment is scored between 0 and 3. The highest score in BBPS is 9, indicating that all segments of the colon are completely clean, while 0 points suggest inadequate cleanliness.	2 days
Secondary	Patient satisfaction survey	The aim is to evaluate the effects of chewing gum and vibration application on patients' satisfaction levels. This assessment will take into account how satisfied patients are with the colonoscopy process and the complaints they experience before and after the procedure.	2 days