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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04895813
Other study ID # Necmettin ErbakanU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date May 1, 2023

Study information

Verified date October 2023
Source Necmettin Erbakan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Colonoscopy is an endoscopic procedure for diagnosing colon diseases. Patients should be prepared 2-5 days in advance for this procedure and intestinal cleansing should be provided. This is a difficult process and does not admit mistakes. The adequacy of the patient's pre-preparation for this process increases the chances of success. For preliminary preparation, it is recommended to train the patient and reinforce the trainings by phone. Education given to the patient; It contributes positively to patient outcomes, the workload of healthcare personnel in the institution, and costs. Therefore, this study has been planned.


Description:

Colonoscopy is an endoscopic procedure for the diagnosis of colon diseases. For this procedure, patients should be prepared 2-5 days in advance and intestinal cleansing should be provided. Because the adequacy of bowel cleansing provides more accurate results than colonoscopy. Pre-colonoscopy preparation process for the patient; It is very tiring and challenging for reasons such as dieting, taking too much fluid and needing to defecate constantly. After this difficult preparation period, the failure to obtain sufficient imaging from the colonoscopy necessitates going back to the beginning. But patient; If he is informed about the importance of this preparation, how it should be done, medication and fluid intake, diet, and if he is guided, the chances of success in colonoscopy will increase. For this reason, nursing education to be given to the patients before colonoscopy and the guidance of the nurse will reduce the possibility of experiencing these negativities.For this reason, this study was planned as a randomized control in order to obtain results with high evidence value. Both a printed education booklet and a digital booklet will be used and guidance will be provided by phone. As a result of this study; Before the colonoscopy procedure, a material to be used in patient education will be prepared and a printed and digital educational booklet will be provided to Necmettin Erbakan University. With the completion of the colonoscopy procedure in one go: the drugs to be used will not be prescribed repeatedly, no extra medication will be used, the patient will not be given multiple colonoscopy appointments and the procedure will not be repeated. In this way, the workload of physicians and nurses will not increase and the comfort of the patient will not be adversely affected. All of these will provide cost effective results and positive patient outcomes. Publication of the article will contribute to the literature.For this purpose, power analysis was performed, sample size was determined, and a randomization list was created for the participants. It has been planned in accordance with CONSORT. There will be 40 people in the experimental and control groups. The effect size of the study; 0.83, margin of error; 0.05 & power; It is 95%.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 1, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Being between the ages of 18-65 - Being open to communication and cooperation - Being conscious and in a position to answer questions - Volunteering to research Exclusion Criteria: Having a disease that may affect decision making ability (dementia, psychological disorders etc.) - Having sensory losses such as vision and hearing Colonoscopy decision has been made because of emergency and active lower gastro intestinal system bleeding. - Being inpatient at the hospital - Being pregnant

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Education
The patient will be given pre-colonoscopy training and guidance by telephone.

Locations

Country Name City State
Turkey Necmettin Erbakan Univercity Konya

Sponsors (2)

Lead Sponsor Collaborator
Necmettin Erbakan University Necmettin Erbakan Üniversiity

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The patient's anxiety level is low It will be evaluated by the nurse before the colonoscopy procedure. State anxiety scale will be used in evaluation.The scale scores between 20 and 80, the higher the score, the higher the anxiety level Just before the colonoscopy
Primary Hull cleaning of the patient's intestines and obtaining a quality image It will be evaluated by the physician performing the procedure during the colonoscopy procedure. The image obtained from the colonoscope will be evaluated by comparing it with the bowel cleaning scale. when doing a colonoscopy
Primary The patient is discharged earlier from the hospital It refers to the time when the patient is able to go home after the colonoscopy procedure is completed. The patient should feel completely well and there should be no problems with his vital signs. It shows how long the patient is eligible to be discharged after the procedure. immediately after the colonoscopy
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