跳至主要内容
临床试验/NCT05973266
NCT05973266招募中不适用

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

Kubra Sengor1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
quality of bowel preparation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

endoscopist blinded

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Have undergone colon and abdominal surgery Active lower gastrointestinal bleeding Known dementia etc. patients with cognitive disorders

结局指标

主要结局

quality of bowel preparation

时间窗: 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.

次要结局

  • Anxiety(will be administered to patients before colonoscopy)

研究者

发起方
Kubra Sengor
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kubra Sengor

Research Assistant

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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