Bowel Preparation QualityPrepVibeNCT07685652
Bowel Preparation Quality Following Video-Based Intervention and Educational Booklet Versus Standard of Care in an Outpatient Setting
A study testing Verbal Counseling, Tri-lingual Educational Pamphlet and QR-Linked Instructional Videos in people with Bowel Preparation Quality and Colonoscopy, run by Sibu Hospital at 1 site in Malaysia.
Trial summary
High cancellation rates and suboptimal bowel preparation increase patient discomfort, drive economic waste, and compromise clinical outcomes. Despite guideline emphasis on adequate preparation quality, there is no standard on how or when instructions should be delivered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Preparation Quality, Colonoscopy, Patient Education Materials
- What is being tested?
- Verbal Counseling, Tri-lingual Educational Pamphlet and QR-Linked Instructional Videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Outpatients scheduled for elective colonoscopy at Hospital Sibu Endoscopy Unit
- Ability to provide written informed consent
- Access to smartphone or computer with functional internet connectivity
Who cannot join
- History of non-compliance with prescribed medical regimens
- Cognitive impairment, dementia, or significant mental health disorder compromising informed consent
- Illiteracy or inability to read materials in provided languages
- Prior colonic resection or colostomy
- Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS)
- Significant physical disability (bed-bound or wheelchair-dependent)
Show all 11Show fewer
- Contraindication to polyethylene glycol (PEG) bowel preparation
- Severe Chronic Kidney Disease (Stage IV or V; eGFR <15 mL/min/1.73m²)
- Significant cardiac comorbidities (unstable angina, severe heart failure, MI within 6 months)
- Inability or unwillingness to comply with study protocol
- Refusal to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Bowel Preparation Quality Following Video-Based Intervention and Educational Booklet Versus Standard of Care in an Outpatient Setting: A Single-Center, Endoscopist-Blinded Randomized Controlled Trial
High cancellation rates and suboptimal bowel preparation increase patient discomfort, drive economic waste, and compromise clinical outcomes. Despite guideline emphasis on adequate preparation quality, there is no standard on how or when instructions should be delivered. This study compares three common patient education modalities-usual care verbal counseling, written tri-lingual pamphlet, and visual media via smartphone QR code-to determine which yields the best bowel preparation quality as assessed by the Boston Bowel Preparation Scale (BBPS) in an outpatient endoscopy setting.
Read the detailed description
BACKGROUND AND RATIONALE:
Non-pharmacological factors, especially the modality of patient education, may influence bowel preparation quality, yet are underexplored and likely context-dependent based on local staffing, patient characteristics, and practice norms.
STUDY DESIGN:
Prospective, single-endoscopist-blinded, three-arm randomized controlled trial (RCT) with intention-to-treat (ITT) primary analysis. Allocation 1:1:1 using computer-generated random numbers. Endoscopist and endoscopy nurses are blinded to group assignment; participants cannot be blinded due to the nature of the intervention.
SETTING:
Hospital Sibu Endoscopy Unit, Sarawak, Malaysia. Colonoscopies performed by qualified surgeons or registrars under supervision; all endoscopists undergo refresher training on Boston Bowel Preparation Scale (BBPS) scoring for consistency.
STUDY ARMS (INTERVENTIONS):
Arm A (Control): Usual care. Physician/nurse-delivered verbal instructions plus standard pharmacy instructions for bowel preparation solution (split-dose PEG 3L).
Arm B (Written): Tri-lingual (Malay/English/Chinese), plain-language educational leaflet reviewed by health literacy expert, plus brief verbal explanation. Arm C (Visual): Short, structured instructional videos accessible via smartphone QR code, reviewed by health literacy expert, plus brief verbal explanation.
SAMPLE SIZE AND STATISTICAL ANALYSIS:
N=324 (108 per arm). Primary analysis: Intent-to-treat chi-square test comparing adequate vs inadequate BBPS across three arms. Pairwise comparisons with Bonferroni adjustment. Multivariable logistic regression adjusts for prespecified covariates (age, sex, BMI, diabetes, education, language, constipation, study arm).
PRIMARY OUTCOME:
Adequate versus inadequate bowel preparation on Boston Bowel Preparation Scale (BBPS). Adequate = total ≥6 with all segments ≥2.
SECONDARY OUTCOMES:
Polyp detection rate; cecal intubation and withdrawal times; cancellation and repeat rates; patient tolerance; complications; patient-reported clarity and helpfulness; anxiety (VAS-A); demographic predictors.
- Being tested
- Verbal Counseling, Tri-lingual Educational Pamphlet, QR-Linked Instructional Videos
- Keywords
- bowel preparation quality, colonoscopy, Boston Bowel Preparation Scale, patient education, video-based intervention, written educational materials, polyp detection, endoscopy quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal CounselingBehavioural
Standard verbal instructions delivered by physician or nurse regarding bowel preparation regimen, timing, dietary restrictions, and what to expect during procedure.
Tri-lingual Educational PamphletBehavioural
Structured written educational material in Malay, English, and Chinese languages detailing complete bowel preparation instructions, timing, dietary guidance, what to expect, and troubleshooting tips. Provided to participant with brief verbal explanation.
QR-Linked Instructional VideosBehavioural
Short, professionally produced instructional videos accessible via smartphone QR code link. Videos present step-by-step bowel preparation instructions, timing, dietary guidance, common concerns, and what to expect during procedure. Participant scans QR code to access video(s) on their smartphone.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (Verbal Counseling) | Active comparator | Standard physician/nurse-delivered verbal instructions and standard pharmacy information sheet for bowel preparation solution (split-dose PEG 3L, Fortrans) according to hospital protocol. Timing and dietary guidance aligned with standard of care. No additional written or visual materials provided. Receives: Behavioral: Verbal Counseling |
| Written Educational Pamphlet | Experimental | Tri-lingual (Malay, English, Chinese) plain-language educational pamphlet detailing step-by-step bowel preparation instructions, plus brief verbal explanation. Pamphlet reviewed by health literacy expert prior to use. Same preparation solution and regimen as Control arm. Receives: Behavioral: Tri-lingual Educational Pamphlet |
| Visual Media (QR Code Video) | Experimental | Short, structured instructional videos accessible via smartphone QR code explaining bowel preparation procedure step-by-step, plus brief verbal explanation. Videos reviewed by health literacy expert prior to use. Same preparation solution and regimen as Control arm. Receives: Behavioral: QR-Linked Instructional Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS)
Primary outcome dichotomized as adequate versus inadequate bowel preparation. Adequate = total BBPS score ≥6 with all three colon segments (left, transverse, right) scoring ≥2 each (scale 0-3 per segment; range 0-9). Inadequate = total <6 or any segment <2. Assessment performed before any bowel cleansing/lavage.
Measured: On day of colonoscopy procedure, assessed immediately upon colonoscope insertion before lavage (time point: 0 minutes)
Secondary outcomes (9)
Polyp Detection Rate
Proportion of participants with at least one polyp detected during colonoscopy. Documented as yes/no and number of polyps.
Measured: During colonoscopy procedure
Cecal Intubation Time
Time in minutes from colonoscope insertion to identification of cecal landmarks.
Measured: During colonoscopy procedure
Colonoscopy Withdrawal Time
Time in minutes from initiation of scope withdrawal to scope exit at rectum, excluding biopsy/therapeutic time.
Measured: During colonoscopy procedure
Procedure Cancellation Rate
Proportion of participants whose colonoscopy was cancelled and reason for cancellation.
Measured: On day of scheduled colonoscopy
Repeat Colonoscopy Rate
Proportion requiring repeat colonoscopy due to inadequate initial preparation.
Measured: Within 6 months of initial colonoscopy
Patient Tolerance to Bowel Preparation
atient self-reported tolerability using five-point scale: Very Easy, Easy, Neutral, Difficult, Very Difficult.
Measured: Pre-procedure on day of colonoscopy
Procedure-Related Complications
Occurrence of procedure-related complications including perforation, bleeding, post-polypectomy syndrome, or other adverse events. Outcome is dichotomous: Yes (complication occurred) or No (no complications). Lower occurrence rate indicates better outcome.
Measured: During procedure and within 7 days post-procedure
Patient-Reported Clarity of Instructions
Patient perception of clarity using Five-Point Likert Scale (minimum=1 "Strongly Disagree", maximum=5 "Strongly Agree"). Statement: "The instructions were clear." Higher scores indicate greater perceived clarity of instructions (better outcome).
Measured: Pre-procedure on day of colonoscopy
Patient Anxiety Assessment
Patient self-reported anxiety on Visual Analog Scale for Anxiety (VAS-A), 0-10 scale (0=no anxiety, 10=extremely anxious).
Measured: Pre-procedure on day of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Mar 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sibu Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Prasad Mothayapan, MD, Principal investigator, Hospital Sibu, MalaysiaTiong How Chieng, MD, Study director, Hospital Sibu, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685652
- Sponsor's protocol ID
- RSCH-25-05992-BBX
- Other IDs
- NMRR-25-04038-EOB
- Acronym
- PrepVibe
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be made publicly available. De-identified aggregate study data may be available upon reasonable request after publication, subject to institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Preparation Quality Following Video-Based Intervention and Educational Booklet Versus Standard of Care in an Outpatient Setting: A Single-Center, Endoscopist-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07685652
- Acronym / sponsor ID
- PrepVibe / RSCH-25-05992-BBX
- Keywords
- bowel preparation quality, colonoscopy, Boston Bowel Preparation Scale, patient education, video-based intervention, written educational materials, polyp detection, endoscopy quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Sibu HospitalOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High cancellation rates and suboptimal bowel preparation increase patient discomfort, drive economic waste, and compromise clinical outcomes. Despite guideline emphasis on adequate preparation quality, there is no standard on how or when instructions should be delivered. This study compares three common patient education modalities-usual care verbal counseling, written tri-lingual pamphlet, and visual media via smartphone QR code-to determine which yields the best bowel preparation quality as assessed by the Boston Bowel Preparation Scale (BBPS) in an outpatient endoscopy setting.
Detailed description
BACKGROUND AND RATIONALE:
Non-pharmacological factors, especially the modality of patient education, may influence bowel preparation quality, yet are underexplored and likely context-dependent based on local staffing, patient characteristics, and practice norms.
STUDY DESIGN:
Prospective, single-endoscopist-blinded, three-arm randomized controlled trial (RCT) with intention-to-treat (ITT) primary analysis. Allocation 1:1:1 using computer-generated random numbers. Endoscopist and endoscopy nurses are blinded to group assignment; participants cannot be blinded due to the nature of the intervention.
SETTING:
Hospital Sibu Endoscopy Unit, Sarawak, Malaysia. Colonoscopies performed by qualified surgeons or registrars under supervision; all endoscopists undergo refresher training on Boston Bowel Preparation Scale (BBPS) scoring for consistency.
STUDY ARMS (INTERVENTIONS):
Arm A (Control): Usual care. Physician/nurse-delivered verbal instructions plus standard pharmacy instructions for bowel preparation solution (split-dose PEG 3L).
Arm B (Written): Tri-lingual (Malay/English/Chinese), plain-language educational leaflet reviewed by health literacy expert, plus brief verbal explanation. Arm C (Visual): Short, structured instructional videos accessible via smartphone QR code, reviewed by health literacy expert, plus brief verbal explanation.
SAMPLE SIZE AND STATISTICAL ANALYSIS:
N=324 (108 per arm). Primary analysis: Intent-to-treat chi-square test comparing adequate vs inadequate BBPS across three arms. Pairwise comparisons with Bonferroni adjustment. Multivariable logistic regression adjusts for prespecified covariates (age, sex, BMI, diabetes, education, language, constipation, study arm).
PRIMARY OUTCOME:
Adequate versus inadequate bowel preparation on Boston Bowel Preparation Scale (BBPS). Adequate = total ≥6 with all segments ≥2.
SECONDARY OUTCOMES:
Polyp detection rate; cecal intubation and withdrawal times; cancellation and repeat rates; patient tolerance; complications; patient-reported clarity and helpfulness; anxiety (VAS-A); demographic predictors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Verbal Counseling) | Active comparator | Behavioral: Verbal CounselingStandard physician/nurse-delivered verbal instructions and standard pharmacy information sheet for bowel preparation solution (split-dose PEG 3L, Fortrans) according to hospital protocol. Timing and dietary guidance aligned with standard of care. No additional written or visual materials provided. |
| Written Educational Pamphlet | Experimental | Behavioral: Tri-lingual Educational PamphletTri-lingual (Malay, English, Chinese) plain-language educational pamphlet detailing step-by-step bowel preparation instructions, plus brief verbal explanation. Pamphlet reviewed by health literacy expert prior to use. Same preparation solution and regimen as Control arm. |
| Visual Media (QR Code Video) | Experimental | Behavioral: QR-Linked Instructional VideosShort, structured instructional videos accessible via smartphone QR code explaining bowel preparation procedure step-by-step, plus brief verbal explanation. Videos reviewed by health literacy expert prior to use. Same preparation solution and regimen as Control arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Outpatients scheduled for elective colonoscopy at Hospital Sibu Endoscopy Unit
- Ability to provide written informed consent
- Access to smartphone or computer with functional internet connectivity
Key exclusion criteria (11 listed)
- History of non-compliance with prescribed medical regimens
- Cognitive impairment, dementia, or significant mental health disorder compromising informed consent
- Illiteracy or inability to read materials in provided languages
- Prior colonic resection or colostomy
- Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal CounselingStandard verbal instructions delivered by physician or nurse regarding bowel preparation regimen, timing, dietary restrictions, and what to expect during procedure. | Behavioural | Usual Care (Verbal Counseling) |
| Tri-lingual Educational PamphletStructured written educational material in Malay, English, and Chinese languages detailing complete bowel preparation instructions, timing, dietary guidance, what to expect, and troubleshooting tips. Provided to participant with brief verbal explanation. | Behavioural | Written Educational Pamphlet |
| QR-Linked Instructional VideosShort, professionally produced instructional videos accessible via smartphone QR code link. Videos present step-by-step bowel preparation instructions, timing, dietary guidance, common concerns, and what to expect during procedure. Participant scans QR code to access video(s) on their smartphone. | Behavioural | Visual Media (QR Code Video) |
Primary outcome
Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS)
Time frame: On day of colonoscopy procedure, assessed immediately upon colonoscope insertion before lavage (time point: 0 minutes)
Primary outcome dichotomized as adequate versus inadequate bowel preparation. Adequate = total BBPS score ≥6 with all three colon segments (left, transverse, right) scoring ≥2 each (scale 0-3 per segment; range 0-9). Inadequate = total <6 or any segment <2. Assessment performed before any bowel cleansing/lavage.
9 secondary outcomes
Polyp Detection Rate
Time frame: During colonoscopy procedure
Cecal Intubation Time
Time frame: During colonoscopy procedure
Colonoscopy Withdrawal Time
Time frame: During colonoscopy procedure
Procedure Cancellation Rate
Time frame: On day of scheduled colonoscopy
Repeat Colonoscopy Rate
Time frame: Within 6 months of initial colonoscopy
Patient Tolerance to Bowel Preparation
Time frame: Pre-procedure on day of colonoscopy
Procedure-Related Complications
Time frame: During procedure and within 7 days post-procedure
Patient-Reported Clarity of Instructions
Time frame: Pre-procedure on day of colonoscopy
Patient Anxiety Assessment
Time frame: Pre-procedure on day of colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Colonoscopy preparation videosLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data will not be made publicly available. De-identified aggregate study data may be available upon reasonable request after publication, subject to institutional approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prasad Mothayapan, MD principal investigator
Hospital Sibu, Malaysia
Tiong How Chieng, MD study director
Hospital Sibu, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal Counseling, Tri-lingual Educational Pamphlet and QR-Linked Instructional Videos in people with Bowel Preparation Quality and Colonoscopy, run by Sibu Hospital at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prasad Mothayapan, MD (+60-84-343333, mprasad.ge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS) (time frame: On day of colonoscopy procedure, assessed immediately upon colonoscope insertion before lavage (time point: 0 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.