Colon DiseaseNCT05973266
The Effect of Mobile Application-Based Bowel Preparation Training on the Patient's Education Whom Colonoscopy is Planned
A study testing Mobile Application-Based Bowel Preparation Training in people with Colon Disease and Colon Cancer, run by Kubra Sengor at 1 site in Turkey (Türkiye).
Trial summary
Colonoscopy is the examination of the large intestine with an instrument called a colonoscope. To make an accurate evaluation during a colonoscopy performed for diagnosis and treatment, adequate preparation of the large intestine must be made. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Disease, Colon Cancer
- What is being tested?
- Mobile Application-Based Bowel Preparation Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2021to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 Years to 65 Years, Internet-enabled smart phone Outpatient admission to endoscopy Patient undergoing colonoscopy for the first time Patients who agreed to participate in the study
Who cannot join
- Have undergone colon and abdominal surgery Active lower gastrointestinal bleeding Known dementia etc. patients with cognitive disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University - Cerrahpasa (IUC)
Istanbul
kubra sengor
About this study
Official title: The Effect of Mobile Application-Based Bowel Preparation Training on the Patient's Bowel Preparation Compliance, Quality and Anxiety Level in Patients for Whom Colonoscopy is Planned
Colonoscopy is the examination of the large intestine with an instrument called a colonoscope. To make an accurate evaluation during a colonoscopy performed for diagnosis and treatment, adequate preparation of the large intestine must be made. Information given to patients is very important for adequate bowel preparation and adherence to treatment.
Therefore, this study was planned as a prospective, single-blind randomized controlled study to determine the effect of mobile application-based bowel preparation training on patients' bowel preparation compliance, quality and anxiety level in patients scheduled for colonoscopy.
Read more
The study will be carried out with 160 patients (experimental: 80, control: 80) who will apply to the Istanbul University Istanbul Medical Faculty Hospital General Surgery Department Endoscopy Unit, who will undergo colonoscopy as an outpatient.
Both groups will receive oral and written instructions for bowel preparation. In addition, the smart phone app group will received instructions through a medical smart phone app. The primary outcome was the rate of adequate bowel preparation according to the Boston bowel preparation scale score. The secondary outcomes included patient compliance.
Read the detailed description
Colorectal cancers (CRC) are the third most common cancers worldwide, regardless of age and gender, and the second among cancer deaths. In terms of the incidence of colorectal cancers in Turkey, regardless of gender, it ranks third in all age groups (9.8% in men, 8.1% in women) (Turkey Unified Database, 2017). According to the Global Cancer 2020 data published by the International Agency for Research on Cancer (IARC), it is predicted that approximately 21,000 individuals will be diagnosed with colorectal cancer in 2020 and the estimated age-standardized death rate will be 10.1 per 100,000 individuals. Colonoscopy, which is the gold standard for early diagnosis of colorectal cancers, reduces cancer-related morbidity and mortality rates (World Health Organization, 2022).
Colonoscopy is a lower gastrointestinal system endoscopy method that enables imaging of the large intestine (colon) for the purposes of screening, diagnosis, treatment and monitoring of colorectal and anal canal pathologies. In the colonoscopy procedure, adequate intestinal preparation is necessary for a good visualization of the entire mucosa and for an accurate evaluation. American Society for Gastrointestinal Endoscopy (ASGE), ideal bowel preparation (BH); defined as the rapid clearance of all macroscopic and microscopic fecal load in the colon without disturbing the patient's comfort and fluid-electrolyte balance.
Inadequate bowel cleansing rates ranging from 10% to 75% have been reported in studies. It is stated that when the bowel preparation of the patients is insufficient, 45% less polyps are detected, and the rate of incomplete and canceled procedures is 5%. In addition, gas compression and explosion, which can be seen rarely as a result of gas insufflation during colonoscopy due to insufficient bowel preparation, can cause perforation of the intestines and undesirable events such as bleeding. As a result, inadequate bowel cleansing can cause repetition or prolongation of the procedure, loss of labor, time and cost for patients and healthcare personnel.
Before colonoscopy, nurses provide patients with written and oral bowel preparation standard training set by the institution. However, many studies suggest that this training should be supported by visual and auditory tools to increase its effectiveness. In interventional studies aimed at increasing the effectiveness of colonoscopy bowel preparation, the use of educational booklets, patient education with poster images, patient education with both visual use and educational videos, telephone/short message, interactive social media and patient education with the use of telephone applications methods were used.
As a result of the literature review, Mobile Application Based Bowel Preparation Training, which is an innovative method, was planned in order to improve the quality of colonoscopy bowel preparation. In this study, it was determined that the quality of bowel preparation and compliance with the procedure will increase by applying Mobile Application-Based Bowel Preparation Training together with the standard education method in patient education before colonoscopy; anxiety is predicted to decrease.
Aim This study was planned as a prospective, single-blind randomized controlled study to determine the effect of mobile application-based bowel preparation training on patients' bowel preparation compliance, quality and anxiety level in patients scheduled for colonoscopy. With the increase in the quality of bowel preparation, effective and accurate evaluation of colon pathologies during colonoscopy and, as a result, early diagnosis of colon cancer will be provided. With adequate bowel preparation, the risk of complications (perforation, hemorrhage, etc.) that may occur during colonoscopy will be reduced, and labor, time and cost loss due to repeated or prolonged colonoscopy will be prevented.
Material Method In this study, in order to determine the effect of mobile application-based bowel preparation training on the quality of bowel preparation, compliance and anxiety level of patients who are planned for colonoscopy; The calculation (d-value) method developed by Cohen was used to calculate the effect size. To determine the effect size index d. The findings of the study, which investigated the effect of mobile application on patient bowel cleansing before colonoscopy, were used. In the calculation made using the findings of this study, the effect size of the bowel cleansing efficiency between the two groups (Experiment=7.70±1.1; Control=7.70±0.8; p=0.007) was determined to be d=0.48. In this context, a sample group of 140 people, 70 people in each group, was determined with the help of the G-power (version 3.1) package program, accompanied by the specified criteria, with d=0.48, α=0.05 (error margin), 1-β=0.80 (power). Due to the loss of patients who left the study during data collection, 10 individuals will be added to the experimental and control groups, and the data collection process will be completed. The sample will consist of patients who meet the inclusion criteria and agree to participate in the study, whose colonoscopy procedure is planned.
- Conditions
- Colon Disease, Colon Cancer
- Being tested
- Mobile Application-Based Bowel Preparation Training
- Keywords
- colonoscopy, bowel preparation, mobile application
- Medical subject headings
- Colonic Diseases, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application-Based Bowel Preparation TrainingBehavioural
The contents of the training in the mobile application where the patients receive bowel preparation training before the procedure are; short videos, images and slides about colonoscopy, bowel preparation drugs, liquid-clear diet and foods recommendations.A mobile application-based training will be provided to guide patients, where user (patient) usage activities are monitored by the researcher, sending notifications or reminders to the patient in accordance with the colonoscopy procedure date.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients using mobile application as well as verbal and written information in bowel preparation training in patients who will undergo colonoscopy will constitute the experimental group. Receives: Behavioral: Mobile Application-Based Bowel Preparation Training |
| Control Group | No intervention | Patients who will be given oral and written information in bowel preparation training in patients who will undergo colonoscopy will form the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of bowel preparation
The Boston bowel preparation scale is a four-point (0-3) assessment tool for bowel cleansing administered separately for each of the three sections of the colon during colonoscopy.Each region of the colon receives a "segment score" from 0 to 3 and these segment scores are summed for a total Boston bowel preparation scale score ranging from 0 to 9. Therefore, the maximum Boston bowel preparation scale score for a perfectly clean colon without any residual liquid is 9 and the minimum Boston bowel preparation scale score for an unprepared colon is 0.
Measured: filled in by the endoscopist during the colonoscopy procedure after training
Secondary outcomes (1)
Anxiety
State-Trait Anxiety Inventory (STAI); STAI-I was developed by Spielberger in 1970. The scale consists of 20 items. The answers range from 1-4. The total point value obtained from the scale is between 20-80. A high score indicates a high level of anxiety. STAI 2 Trait Anxiety Scale; It aims to measure how the individual feels, that is, his trait anxiety, regardless of the situation and conditions he is in. These individuals also experience state anxiety more frequently and intensely than others. In answering the state anxiety scale; choosing one of the options "Not at all", "A little", "A lot", "Totally" according to the level of severity of the feelings, behaviors or thoughts expressed by the items; In answering the trait anxiety scale, it is required to select and mark one of the options "Almost Never", "Sometimes", "Very Often" and "Almost Always" according to the frequency level of the feelings, behaviors or thoughts expressed by the items.
Measured: will be administered to patients before colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start3 Jun 2021
- Primary completion27 Oct 2023 (estimated)
- Study completion29 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled experimental design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kubra Sengor
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Kubra Sengor, Istanbul University - Cerrahpasa
- Investigators
- Kübra Şengör, Msc, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973266
- Sponsor's protocol ID
- IstanbulUC-FNHF-KS-01
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sengor K, Keskin M, Akyuz N. Mobile app-based bowel preparation training: effects on compliance, quality, and anxiety in colonoscopy patients-a randomized controlled trial. Surg Endosc. 2025 Nov;39(11):7312-7323. doi: 10.1007/s00464-025-12074-9. Epub 2025 Aug 27.
PubMed 40866593
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Application-Based Bowel Preparation Training on the Patient's Bowel Preparation Compliance, Quality and Anxiety Level in Patients for Whom Colonoscopy is Planned
- ClinicalTrials.gov ID
- NCT05973266
- Acronym / sponsor ID
- IstanbulUC-FNHF-KS-01
- Conditions
- Colon Disease, Colon Cancer
- Keywords
- colonoscopy, bowel preparation, mobile application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Kubra SengorUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 27 Oct 2023 (estimated)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 2 Aug 2023 (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.
Colonoscopy is the examination of the large intestine with an instrument called a colonoscope. To make an accurate evaluation during a colonoscopy performed for diagnosis and treatment, adequate preparation of the large intestine must be made. Information given to patients is very important for adequate bowel preparation and adherence to treatment.
Therefore, this study was planned as a prospective, single-blind randomized controlled study to determine the effect of mobile application-based bowel preparation training on patients' bowel preparation compliance, quality and anxiety level in patients scheduled for colonoscopy.
The study will be carried out with 160 patients (experimental: 80, control: 80) who will apply to the Istanbul University Istanbul Medical Faculty Hospital General Surgery Department Endoscopy Unit, who will undergo colonoscopy as an outpatient.
Both groups will receive oral and written instructions for bowel preparation. In addition, the smart phone app group will received instructions through a medical smart phone app. The primary outcome was the rate of adequate bowel preparation according to the Boston bowel preparation scale score. The secondary outcomes included patient compliance.
Detailed description
Colorectal cancers (CRC) are the third most common cancers worldwide, regardless of age and gender, and the second among cancer deaths. In terms of the incidence of colorectal cancers in Turkey, regardless of gender, it ranks third in all age groups (9.8% in men, 8.1% in women) (Turkey Unified Database, 2017). According to the Global Cancer 2020 data published by the International Agency for Research on Cancer (IARC), it is predicted that approximately 21,000 individuals will be diagnosed with colorectal cancer in 2020 and the estimated age-standardized death rate will be 10.1 per 100,000 individuals. Colonoscopy, which is the gold standard for early diagnosis of colorectal cancers, reduces cancer-related morbidity and mortality rates (World Health Organization, 2022).
Colonoscopy is a lower gastrointestinal system endoscopy method that enables imaging of the large intestine (colon) for the purposes of screening, diagnosis, treatment and monitoring of colorectal and anal canal pathologies. In the colonoscopy procedure, adequate intestinal preparation is necessary for a good visualization of the entire mucosa and for an accurate evaluation. American Society for Gastrointestinal Endoscopy (ASGE), ideal bowel preparation (BH); defined as the rapid clearance of all macroscopic and microscopic fecal load in the colon without disturbing the patient's comfort and fluid-electrolyte balance.
Inadequate bowel cleansing rates ranging from 10% to 75% have been reported in studies. It is stated that when the bowel preparation of the patients is insufficient, 45% less polyps are detected, and the rate of incomplete and canceled procedures is 5%. In addition, gas compression and explosion, which can be seen rarely as a result of gas insufflation during colonoscopy due to insufficient bowel preparation, can cause perforation of the intestines and undesirable events such as bleeding. As a result, inadequate bowel cleansing can cause repetition or prolongation of the procedure, loss of labor, time and cost for patients and healthcare personnel.
Before colonoscopy, nurses provide patients with written and oral bowel preparation standard training set by the institution. However, many studies suggest that this training should be supported by visual and auditory tools to increase its effectiveness. In interventional studies aimed at increasing the effectiveness of colonoscopy bowel preparation, the use of educational booklets, patient education with poster images, patient education with both visual use and educational videos, telephone/short message, interactive social media and patient education with the use of telephone applications methods were used.
As a result of the literature review, Mobile Application Based Bowel Preparation Training, which is an innovative method, was planned in order to improve the quality of colonoscopy bowel preparation. In this study, it was determined that the quality of bowel preparation and compliance with the procedure will increase by applying Mobile Application-Based Bowel Preparation Training together with the standard education method in patient education before colonoscopy; anxiety is predicted to decrease.
Aim This study was planned as a prospective, single-blind randomized controlled study to determine the effect of mobile application-based bowel preparation training on patients' bowel preparation compliance, quality and anxiety level in patients scheduled for colonoscopy. With the increase in the quality of bowel preparation, effective and accurate evaluation of colon pathologies during colonoscopy and, as a result, early diagnosis of colon cancer will be provided. With adequate bowel preparation, the risk of complications (perforation, hemorrhage, etc.) that may occur during colonoscopy will be reduced, and labor, time and cost loss due to repeated or prolonged colonoscopy will be prevented.
Material Method In this study, in order to determine the effect of mobile application-based bowel preparation training on the quality of bowel preparation, compliance and anxiety level of patients who are planned for colonoscopy; The calculation (d-value) method developed by Cohen was used to calculate the effect size. To determine the effect size index d. The findings of the study, which investigated the effect of mobile application on patient bowel cleansing before colonoscopy, were used. In the calculation made using the findings of this study, the effect size of the bowel cleansing efficiency between the two groups (Experiment=7.70±1.1; Control=7.70±0.8; p=0.007) was determined to be d=0.48. In this context, a sample group of 140 people, 70 people in each group, was determined with the help of the G-power (version 3.1) package program, accompanied by the specified criteria, with d=0.48, α=0.05 (error margin), 1-β=0.80 (power). Due to the loss of patients who left the study during data collection, 10 individuals will be added to the experimental and control groups, and the data collection process will be completed. The sample will consist of patients who meet the inclusion criteria and agree to participate in the study, whose colonoscopy procedure is planned.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled experimental design
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Mobile Application-Based Bowel Preparation TrainingPatients using mobile application as well as verbal and written information in bowel preparation training in patients who will undergo colonoscopy will constitute the experimental group. |
| Control Group | No intervention | –Patients who will be given oral and written information in bowel preparation training in patients who will undergo colonoscopy will form the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 Years to 65 Years, Internet-enabled smart phone Outpatient admission to endoscopy Patient undergoing colonoscopy for the first time Patients who agreed to participate in the study
Key exclusion criteria (1 listed)
- Have undergone colon and abdominal surgery Active lower gastrointestinal bleeding Known dementia etc. patients with cognitive disorders
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 |
|---|---|---|
| Mobile Application-Based Bowel Preparation TrainingThe contents of the training in the mobile application where the patients receive bowel preparation training before the procedure are; short videos, images and slides about colonoscopy, bowel preparation drugs, liquid-clear diet and foods recommendations.A mobile application-based training will be provided to guide patients, where user (patient) usage activities are monitored by the researcher, sending notifications or reminders to the patient in accordance with the colonoscopy procedure date. | Behavioural | Experimental Group |
Primary outcome
quality of bowel preparation
Time frame: filled in by the endoscopist during the colonoscopy procedure after training
The Boston bowel preparation scale is a four-point (0-3) assessment tool for bowel cleansing administered separately for each of the three sections of the colon during colonoscopy.Each region of the colon receives a "segment score" from 0 to 3 and these segment scores are summed for a total Boston bowel preparation scale score ranging from 0 to 9. Therefore, the maximum Boston bowel preparation scale score for a perfectly clean colon without any residual liquid is 9 and the minimum Boston bowel preparation scale score for an unprepared colon is 0.
1 secondary outcome
Anxiety
Time frame: will be administered to patients before colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 40866593Sengor K, Keskin M, Akyuz N. Mobile app-based bowel preparation training: effects on compliance, quality, and anxiety in colonoscopy patients-a randomized controlled trial. Surg Endosc. 2025 Nov;39(11):7312-7323. doi: 10.1007/s00464-025-12074-9. Epub 2025 Aug 27.
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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. This study is not recruiting at the moment.
Kübra Şengör, Msc principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application-Based Bowel Preparation Training in people with Colon Disease and Colon Cancer, run by Kubra Sengor at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Aug 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kübra Şengör, Msc (05422713460, kubra.sengor@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of bowel preparation (time frame: filled in by the endoscopist during the colonoscopy procedure after training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05973266, which also lists 1 linked publication.
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 3 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.