Effect of Counseling and Education on Mechanical Bowel Preparation

NCT07093099 | Completed

• 1 other identifier: 2021/134/162
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether enhanced education and counseling can improve bowel preparation before colonoscopy in high-risk patients. The main questions it aims to answer are: Does enhanced education lead to better bowel cleansing as measured by the Boston Bowel Preparation Scale (BBPS)? Does it improve patient satisfaction, compliance with instructions, and procedure efficiency? Researchers will compare an enhanced education program (including counseling, video, booklet, and mobile app) to standard written instructions typically given before colonoscopy. Participants will: Be randomly assigned to either the enhanced education group or the standard instruction group Undergo routine colonoscopy after following the assigned preparation method Complete short questionnaires about their experience, satisfaction, and willingness to repeat the process This study is being done at two hospitals in Palestine.

Conditions

Colonoscopy; Colorectal Cancer Screening

Keywords

Bowel prep; Colonoscopy preparation; BBPS (Boston Bowel Preparation Scale); Enhanced education

Outcome Measures

Primary Outcomes (1)

• Boston Bowel Preparation Scale (BBPS) Total Score

  The BBPS is a validated scoring system to assess bowel cleanliness during colonoscopy. It ranges from 0-9, with three sub-scores (right, transverse, left colon) each scored 0-3. Higher scores indicate better bowel preparation quality. Total BBPS score will be compared between groups.

  During the procedure itself

Secondary Outcomes (3)

• Patient Satisfaction Score

  Within 24 hours after colonoscopy

• Cecal Intubation Time

  During the procedure itself

• Willingness to Repeat Preparation

  Within 24 hours after colonoscopy

Study Arms (2)

Enhanced Education Group

EXPERIMENTAL

Participants in this group received enhanced bowel preparation education. The intervention included: Face-to-face counseling by trained staff about the importance of bowel prep and how to follow instructions; A 6-minute instructional video explaining dietary restrictions, purgative usage, and procedure timeline; A printed booklet with illustrated step-by-step instructions; and Access to a smartphone app with automated reminders, preparation tracking, and guidance. All participants used the same bowel cleansing agent (polyethylene glycol-based preparation).

Behavioral: Enhanced Education Package for Bowel Preparation; Other: Standard Education Leaflet

Standard Education Group

ACTIVE COMPARATOR

Participants in this group received standard bowel preparation instructions in the form of a hospital-issued informational leaflet. This leaflet included basic written instructions about dietary restrictions, timing and method of laxative use, and preparation day logistics. No counseling, video, or app-based support was provided. The same bowel cleansing agent was used in both arms.

Other: Standard Education Leaflet

Interventions

Enhanced Education Package for Bowel Preparation BEHAVIORAL

a multifaceted intervention was designed to improve mechanical bowel preparation (MBP) in patients undergoing colonoscopy. It included: Structured face-to-face counseling on the importance of bowel prep, potential complications of poor prep, and how to follow instructions. A 6-minute instructional video explaining step-by-step dietary and medication instructions. A printed booklet with visual aids summarizing key steps. A mobile phone app delivering interactive reminders, tracking tools, and preparation guidance. All participants used the same polyethylene glycol-based bowel cleansing agent.

Also known as: Enhanced Counseling, Video Instruction, Booklet and Mobile App Support

Enhanced Education Group

Standard Education Leaflet OTHER

Participants in this arm received a standard hospital-issued bowel preparation instruction leaflet. The document provided written instructions on dietary modifications, timing and dosage of the bowel cleansing agent, and day-of-procedure guidance. No personalized counseling, video support, or reminder tools were provided. This reflects the routine care practice at the study hospitals.

Also known as: Standard Instructions, Usual Care Preparation

Enhanced Education Group; Standard Education Group

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Undergoing elective colonoscopy
• Considered high-risk for inadequate bowel preparation, including at least one of the following:
• Prior abdominal or pelvic surgery
• Chronic constipation (fewer than 3 bowel movements per week)
• Use of constipating medications (e.g., opioids, tricyclic antidepressants, calcium channel blockers)
• Age \>65 years
• Multiple comorbidities (e.g., diabetes, neurologic disorders affecting motility)
• \----------------------------------------------------

You may not qualify if:

• Known allergy or intolerance to bowel preparation agents
• Pregnancy
• Severe comorbidities (e.g., decompensated liver disease, severe heart failure)
• Cognitive impairment or illiteracy preventing understanding of instructions
• Emergency colonoscopy or known obstructive colorectal disease

Sponsors & Collaborators

• Al-Ram Drug Store: lead
• An-Najah National University: collaborator

Study Sites (1)

Rafidia Surgical Hospital

Nablus, P400, Palestinian Territories

Location

Study Officials

• Mohammed M Hajhamad, MD

  An-Najah National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Endoscopists scoring bowel preparation using the Boston Bowel Preparation Scale (BBPS) were blinded to the participant's group assignment. Participants and care providers were not masked due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MB, BCH (Egypt) DoS (Malaysia) Consultant Surgeon and Endoscopist Head of Department of Continuous Medical Education and Clinical Research - Rafidia Surgical Hospital

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 30, 2025
• Study Start: December 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: May 20, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)