The Effect of Audio-visual Aids on Bowel CleanlinessVACPNCT07155603
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
A study testing Animated Video Group 1 in people with The Effect of Audio-visual Aids on Bowel Cleanliness and Audiovisual Aids, run by Prof. Dr. Jörg Leuppi at 1 site in Switzerland.
Trial summary
Effective communication in healthcare is critical for improving patient outcomes, particularly in enhancing health literacy and enabling informed decision-making. Traditional informed consent for colonoscopy often fails to clearly explain the procedure, risks, and preparation requirements, leading to inadequate bowel… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
- What is being tested?
- Animated Video Group 1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2025to 15 Dec 2028
- 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
- 18 years or older
- Scheduled for a routine outpatient colonoscopy procedure
- Capable of understanding communication in German and willing to participate in the study
Who cannot join
- Patients with cognitive impairments
- Those unwilling to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Cantonal Hospital of Baselland
Liestal, 4410
Zahra Pasha, 0041 61 400 40 40, zahra.pasha@ksbl.ch
Zahra Pasha, B.A, M.A., TESOL, iPGCE, MCIL
About this study
Effective communication in healthcare is critical for improving patient outcomes, particularly in enhancing health literacy and enabling informed decision-making. Traditional informed consent for colonoscopy often fails to clearly explain the procedure, risks, and preparation requirements, leading to inadequate bowel preparation, longer procedures, and missed lesions. Standard educational materials like videos and written instructions are often impersonal, lack cultural inclusivity, and fail to engage patients effectively. Emerging tools, such as the multilingual, visually enhanced Meine Behandlung video series from Visikon®, aim to improve patient comprehension and adherence. This study seeks to compare the effectiveness of these animated videos against traditional consent methods in enhancing patient understanding and adherence, particularly for complex procedures like colonoscopy, which is crucial for diagnosing and preventing colorectal cancer.
- Being tested
- Animated Video Group 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animated Video Group 1Behavioural
The animated video intervention provides a clear and engaging multimedia explanation of the colonoscopy procedure in multiple languages. It includes visual aids to help explain the process, preparation instructions, risks, and expected outcomes, aiming to improve patient comprehension and adherence.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Consent (Control Group) | Active comparator | The traditional informed consent process involves the provision of written documents and verbal explanation to the patient regarding the colonoscopy procedure, risks, and preparation requirements Receives: Behavioral: Animated Video Group 1 |
| Animated Video 1 | Experimental | Patients of this group will be asked to watch the Visikon animated videos, in addition to receiving standard informed consent Receives: Behavioral: Animated Video Group 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Preperation
The objective of assessing the primary endpoint the patient's bowel cleanliness, will be measured during the routine colonoscopy, using the Boston Bowel Preperation Scale.
The Boston Bowel Preparation Scale (BBPS) is a validated tool used to assess the cleanliness of the colon during a colonoscopy,
Each of the three segments of the colon (right, transverse, and left) is assigned a score ranging from 0 to 3, with the following criteria:
Total Score 0: The entire colon is unprepared, and no mucosa is visible. Total Score 1-3: Poor preparation, significant portions of the mucosa are not visible.
Total Score 4-6: Fair preparation, with some portions of the mucosa visible but others obscured.
Total Score 7-9: Good to excellent preparation, with most or all mucosa well visualized.
Interpretation Scores of 0-3: Generally considered inadequate for proper assessment and diagnosis, likely requiring repeat preparation and examination.
Scores of 4-6: Indicative of suboptimal preparation
Measured: 24 months
Secondary outcomes (1)
Patient Health Literacy & Communication Satisfaction
The secondary outcome seeks to assess the patient's health literacy and general communication satisfaction. This will be done by assessing their answers to the Health Literacy Questionnaire.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study startSep 2025 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Effect of Audio-visual Aids on Bowel CleanlinessStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Jörg Leuppi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Jörg Leuppi, Cantonal Hospital, Baselland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155603
- Sponsor's protocol ID
- 2024-01572
- Acronym
- VACP
- Status last verified
- Sep 2025
- First submitted
- 10 Mar 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
- ClinicalTrials.gov ID
- NCT07155603
- Acronym / sponsor ID
- VACP / 2024-01572
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Prof. Dr. Jörg LeuppiUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 4 Sep 2025 (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.
Effective communication in healthcare is critical for improving patient outcomes, particularly in enhancing health literacy and enabling informed decision-making. Traditional informed consent for colonoscopy often fails to clearly explain the procedure, risks, and preparation requirements, leading to inadequate bowel preparation, longer procedures, and missed lesions. Standard educational materials like videos and written instructions are often impersonal, lack cultural inclusivity, and fail to engage patients effectively. Emerging tools, such as the multilingual, visually enhanced Meine Behandlung video series from Visikon®, aim to improve patient comprehension and adherence. This study seeks to compare the effectiveness of these animated videos against traditional consent methods in enhancing patient understanding and adherence, particularly for complex procedures like colonoscopy, which is crucial for diagnosing and preventing colorectal cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Consent (Control Group) | Active comparator | Behavioral: Animated Video Group 1The traditional informed consent process involves the provision of written documents and verbal explanation to the patient regarding the colonoscopy procedure, risks, and preparation requirements |
| Animated Video 1 | Experimental | Behavioral: Animated Video Group 1Patients of this group will be asked to watch the Visikon animated videos, in addition to receiving standard informed consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Scheduled for a routine outpatient colonoscopy procedure
- Capable of understanding communication in German and willing to participate in the study
Key exclusion criteria (2 listed)
- Patients with cognitive impairments
- Those unwilling to participate
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 |
|---|---|---|
| Animated Video Group 1The animated video intervention provides a clear and engaging multimedia explanation of the colonoscopy procedure in multiple languages. It includes visual aids to help explain the process, preparation instructions, risks, and expected outcomes, aiming to improve patient comprehension and adherence. | Behavioural | Animated Video 1, Traditional Consent (Control Group) |
Primary outcome
Bowel Preperation
Time frame: 24 months
The objective of assessing the primary endpoint the patient's bowel cleanliness, will be measured during the routine colonoscopy, using the Boston Bowel Preperation Scale. The Boston Bowel Preparation Scale (BBPS) is a validated tool used to assess the cleanliness of the colon during a colonoscopy, Each of the three segments of the colon (right, transverse, and left) is assigned a score ranging from 0 to 3, with the following criteria: Total Score 0: The entire colon is unprepared, and no mucosa is visible. Total Score 1-3: Poor preparation, significant portions of the mucosa are not visible. Total Score 4-6: Fair preparation, with some portions of the mucosa visible but others obscured. Total Score 7-9: Good to excellent preparation, with most or all mucosa well visualized. Interpretation Scores of 0-3: Generally considered inadequate for proper assessment and diagnosis, likely requiring repeat preparation and examination. Scores of 4-6: Indicative of suboptimal preparation
1 secondary outcome
Patient Health Literacy & Communication Satisfaction
Time frame: 24 months
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 4 Sep 2025.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animated Video Group 1 in people with The Effect of Audio-visual Aids on Bowel Cleanliness and Audiovisual Aids, run by Prof. Dr. Jörg Leuppi at 1 site in Switzerland.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Sep 2025. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Preperation (time frame: 24 months). 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 4 Sep 2025.