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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Konya, Turkey, 42370
        • Necmettin Erbakan Univercity

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Education
The patient will be given pre-colonoscopy training and guidance by telephone.
Other Names:
  • Gudiance
No Intervention: Group 2
Routine information in the service will be made

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Just before the colonoscopy
Hull cleaning of the patient's intestines and obtaining a quality image
Time Frame: when doing a colonoscopy
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
The patient is discharged earlier from the hospital
Time Frame: immediately after the colonoscopy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Necmettin Erbakan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Necmettin Erbakan Üniversiity

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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