- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04895813
The Effect of Education and Telephone Guidance at Colonoscopy
October 24, 2023 updated by: Rukiye Burucu, Necmettin Erbakan University
The Effect of Education and Telephone Guidance Given to the Patient Before Colonoscopy on the Patient's Anxiety Level and Bowel Preparation: A Randomized Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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%.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Konya, Turkey, 42370
- Necmettin Erbakan Univercity
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1:
The patient will be given training on the day the appointment is made for colonoscopy, educational material will be given as a reminder, information will be given on the phone and the training will be reminded on the day he should start diet for colonoscopy.
No different application will be made on the day and after the colonoscopy.
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The patient will be given pre-colonoscopy training and guidance by telephone.
Other Names:
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No Intervention: Group 2
Routine information in the service will be made
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The patient's anxiety level is low
Time Frame: Just before the colonoscopy
|
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
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Just before the colonoscopy
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Hull cleaning of the patient's intestines and obtaining a quality image
Time Frame: when doing a colonoscopy
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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.
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when doing a colonoscopy
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The patient is discharged earlier from the hospital
Time Frame: immediately after the colonoscopy
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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.
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immediately after the colonoscopy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
March 30, 2023
Study Completion (Actual)
May 1, 2023
Study Registration Dates
First Submitted
May 8, 2021
First Submitted That Met QC Criteria
May 19, 2021
First Posted (Actual)
May 20, 2021
Study Record Updates
Last Update Posted (Actual)
October 25, 2023
Last Update Submitted That Met QC Criteria
October 24, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Necmettin ErbakanU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
It will be decided upon completion of the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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