Effect of Counseling and Education on Mechanical Bowel Preparation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2025-05-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Colonoscopy Colorectal Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Enhanced Education Group

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).

Group Type EXPERIMENTAL

Enhanced Education Package for Bowel Preparation

Intervention Type 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.

Standard Education Leaflet

Intervention Type 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.

Standard Education Group

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.

Group Type ACTIVE_COMPARATOR

Standard Education Leaflet

Intervention Type 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.

Interventions

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Enhanced Education Package for Bowel Preparation

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.

Intervention Type BEHAVIORAL

Standard Education Leaflet

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.

Intervention Type OTHER

Other Intervention Names

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Enhanced Counseling Video Instruction Booklet and Mobile App Support Standard Instructions Usual Care Preparation

Eligibility Criteria

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Inclusion Criteria

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)

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Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Mohammed M. H. Hajhamad

MB, BCH (Egypt) DoS (Malaysia) Consultant Surgeon and Endoscopist Head of Department of Continuous Medical Education and Clinical Research - Rafidia Surgical Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR