Effectiveness of Gum Chewing on Polyethylene Glycol Related Intake Adherence, GI Side Effects and Bowel Preparation

NCT05328219 | Completed

• 1 other identifier: ILBSIndia21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Problem statement An Experimental Study to assess the effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation among Patients Undergoing Colonoscopy at ILBS, New Delhi. Objectives of the study The objectives of the study are: Primary objective 1\. To compare the effect of gum chewing in experimental vs. control groups in terms of PEG Related Intake Adherence, GI side effects and Bowel Preparation among Patients Undergoing Colonoscopy. Secondary objective

1. 1.To find the relationship of total amount of fluid taken with GI side effects and Bowel Preparation variables in patients undergoing colonoscopy under experimental group.
2. 2.To determine the association of PEG Related Intake Adherence, GI side effects and Bowel Preparation among Patients with socio-demographic and clinical variables in patients undergoing colonoscopy under experimental group.

Conditions

Colonoscopy

Keywords

Colonoscopy; Chewing gum; Intake Adherence; Bowel preparation

Outcome Measures

Primary Outcomes (3)

• Number of patients with complete intake of PEG solution (2 litre) in both groups

  Intake Adherence among Patients Undergoing Colonoscopy was assessed by Intake Adherence tool comprises of 4 items which include time spent in ingesting the whole PEG solution in minutes, total amount of PEG solution taken, extra fluid taken other than PEG solution, total amount of fluid taken in milliliters.

  up to 5 weeks

• Number of patients with change in GI side effects related to PEG solution in both groups

  GI side effects among Patients Undergoing Colonoscopy was assessed by Numerical Rating Scale and the Rhodes Index of Nausea, Vomiting, And Retching (INVR).

  up to 5 weeks

• Improvement in bowel preparation in both groups

  Bowel Preparation among Patients Undergoing Colonoscopy was assessed by Boston Bowel Preparation Scale. A four-point scoring system with maximum score of 9 and minimum score of 0 applied to each of the three broad regions of the colon: the right colon (including the cecum and ascending colon), the transverse colon (including the hepatic and splenic flexures), and the left colon (including the descending colon, sigmoid colon, and rectum).

  up to 5 weeks

Study Arms (2)

Chewing gums with PEG solution

EXPERIMENTAL

The investigator provide the chewing gums with PEG solution to the experimental group.

Other: Chewing gums with PEG solution

Standard of Care

ACTIVE COMPARATOR

Care provided as per the standard existing routine.

Other: Standard of care

Interventions

Chewing gums with PEG solution OTHER

Patients undergoing colonoscopy under experimental group was advised to take 2L of PEG solution and packets of sugarless sweet mint flavored chewing gums. The patients are advised to Chew one stick of sugarless gum for at least 10 min after taking each glass of PEG solution and discard the chewing gum before taking next glass.

Chewing gums with PEG solution

Standard of care OTHER

Standard of care

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OPD Patients who -
• Have been planned for elective colonoscopy for therapeutic and/or diagnostic purposes.
• Have been prescribed PEG solution for bowel preparation.
• Are able to chew gum.
• Are willing to participate in the study.
• Can read and write English or Hindi.

You may not qualify if:

• Patients who -
• Are critically ill.
• Are on anti-emetic therapy.
• Have some psychiatric issues making them unable to follow the instructions.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Pooja Chaudhary

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Chewing Gum; Standard of Care

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; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Pooja Ms Chaudhary, Nursing

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: April 14, 2022
• Study Start: November 1, 2021
• Primary Completion: November 14, 2021
• Study Completion: December 5, 2021
• Last Updated: May 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)