Trial Title:
The Effect of Mobile Application-Based Bowel Preparation Training on the Patient's Education Whom Colonoscopy is Planned
NCT ID:
NCT05973266
Condition:
Colon Disease
Colon Cancer
Conditions: Official terms:
Colonic Diseases
Conditions: Keywords:
colonoscopy
bowel preparation
mobile application
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
Randomized controlled experimental design
Primary purpose:
Other
Masking:
Single (Outcomes Assessor)
Masking description:
endoscopist blinded
Intervention:
Intervention type:
Behavioral
Intervention name:
Mobile Application-Based Bowel Preparation Training
Description:
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.
Arm group label:
Experimental Group
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Have undergone colon and abdominal surgery Active lower gastrointestinal bleeding
Known dementia etc. patients with cognitive disorders
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Istanbul University - Cerrahpasa (IUC)
Address:
City:
Istanbul
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
kubra sengor
Start date:
June 3, 2021
Completion date:
December 29, 2023
Lead sponsor:
Agency:
Kubra Sengor
Agency class:
Other
Collaborator:
Agency:
The Scientific and Technological Research Council of Turkey
Agency class:
Other
Source:
Istanbul University - Cerrahpasa (IUC)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05973266
