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Patient Education and Text Message Reminders in Colonoscopy

Primary Purpose

Colon Disease, Educational Problems

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education Group
Text Message Group
Sponsored by
Amasya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colon Disease focused on measuring colonoscopy, patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals who understand Turkish Individuals who know how to use a phone and read text messages Individuals over 18 years of age Patients undergoing colonoscopy for the first time Exclusion Criteria: Patients with cognitive dysfunction Patients with neuro-psychiatric disorders Individuals who do not know how to use a phone Individuals undergoing colonoscopy in emergency situations Individuals who did not give consent to participate in the research

Sites / Locations

  • Amasya URecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Education Group

Text Message Group

Control Group:

Arm Description

The training material will be created by researchers by reviewing national and international guidelines for colonoscopy practices. Using the "Colonoscopy Patient Preparation Guide", individuals will be given face-to-face, information and preparation training on colonoscopy preparation, its importance, the preparation medication to be used and the procedure process for an average of 15-20 minutes in a private room in the unit. After the training, individuals will be given the "Colonoscopy Patient Preparation Guide" brochure developed by the researchers.

Individuals will be subjected to the routine colonoscopy preparation procedure of the hospital by the investigator. Starting three days before the colonoscopy is performed, individuals will be informed via text messages about the foods and beverages that they can consume in their diet and those that are forbidden to consume until the morning of the colonoscopy, the amount of fluids they should consume daily, the use of medication, the use of soda and enema, appointment time reminders.

Individuals in the control group will be subjected to the standard procedure applied in the clinic. No additional education and educational brochures will be given to these patients and text message reminders will not be applied.

Outcomes

Primary Outcome Measures

Beck Anxiety Scale
Beck Depression Scale (BDS) was developed by Beck. The scale was created to include clinical symptoms seen in depression. The items of the BDS are organized based on clinical observations and data. The scale consists of 21 symptom categories. Each symptom category is addressed with scored sentences ranging from 0-3. The maximum score that can be obtained from the scale is 63. A high total score on the scale indicates a high level or severity of depression
Boston Bowel Readiness Scale
The scale has a four-point (0-3) scoring system applied separately for each of the three parts of the colon. 3- 0 (İnsuffıcıent) : Unprepared colon in which the mucosa cannot be evaluated due to uncleared solid fecal matter. (Bad) = Part of the mucosa is visible in the colon, but other parts are not visible due to contamination, residual fecal matter and/or opaque fluid. (Good) = Colon mucosa is well visualized but there is a small amount of impurities, small pieces of stool and/or opaque fluid. (Excellent) = The entire mucosa of the colon is well visible. No impurities, small pieces of pus or opaque fluid.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2023
Last Updated
October 3, 2023
Sponsor
Amasya University
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1. Study Identification

Unique Protocol Identification Number
NCT06073782
Brief Title
Patient Education and Text Message Reminders in Colonoscopy
Official Title
The Effect of Patient Education and Text Message Reminders on Bowel Preparation and Anxiety Level Before Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2023 (Actual)
Primary Completion Date
December 27, 2023 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amasya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will be conducted to examine the effects of detailed education and text message reminders given to patients undergoing colonoscopy on bowel cleansing, vital signs and anxiety.
Detailed Description
İntroduction: The highest level of bowel preparation before the colonoscopy procedure is necessary for the successful completion of colonoscopy. Considering that the bowel preparation procedures required for colonoscopy are performed by patients, it is very important to inform patients about the content and duration of diet and bowel preparation practices. Today, with the widespread use of technology in our lives, technological education methods such as web-based trainings, text message reminders, telemedicine methods have started to be used in patient education methods as well as classical methods. Purpose: This study will be conducted to examine the effects of detailed education and text message reminders given to patients undergoing colonoscopy on bowel cleansing, vital signs and anxiety. Method: This study will be a randomized controlled trial. hospital. The sample of the study will include individuals who will undergo colonoscopy procedure in the endoscopy unit of a state hospital and who meet the inclusion criteria. Data will be collected using personal information form, beck anxiety scale, boston bowel readiness scale. In this study, in addition to the standard patient education protocol, the effectiveness of colonoscopy education with more intensive content and supported by visuals and diagrams will be evaluated in the education group. Individuals in the other group will receive text message reminders, which is one of the new methods that have started to be used in patient education with the technology that has become widespread today. Conclusion: It is thought that more intensive and materialized trainings and text message reminders to patients compared to standard colonoscopy preparations will increase the level of bowel cleansing, improve vital signs and reduce anxiety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Disease, Educational Problems
Keywords
colonoscopy, patient education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education Group
Arm Type
Experimental
Arm Description
The training material will be created by researchers by reviewing national and international guidelines for colonoscopy practices. Using the "Colonoscopy Patient Preparation Guide", individuals will be given face-to-face, information and preparation training on colonoscopy preparation, its importance, the preparation medication to be used and the procedure process for an average of 15-20 minutes in a private room in the unit. After the training, individuals will be given the "Colonoscopy Patient Preparation Guide" brochure developed by the researchers.
Arm Title
Text Message Group
Arm Type
Experimental
Arm Description
Individuals will be subjected to the routine colonoscopy preparation procedure of the hospital by the investigator. Starting three days before the colonoscopy is performed, individuals will be informed via text messages about the foods and beverages that they can consume in their diet and those that are forbidden to consume until the morning of the colonoscopy, the amount of fluids they should consume daily, the use of medication, the use of soda and enema, appointment time reminders.
Arm Title
Control Group:
Arm Type
No Intervention
Arm Description
Individuals in the control group will be subjected to the standard procedure applied in the clinic. No additional education and educational brochures will be given to these patients and text message reminders will not be applied.
Intervention Type
Other
Intervention Name(s)
Education Group
Intervention Description
The training material will be created by researchers by reviewing national and international guidelines for colonoscopy practices. Using the "Colonoscopy Patient Preparation Guide", individuals will be given face-to-face, information and preparation training on colonoscopy preparation, its importance, the preparation medication to be used and the procedure process for an average of 15-20 minutes in a private room in the unit.
Intervention Type
Other
Intervention Name(s)
Text Message Group
Intervention Description
. Starting three days before the colonoscopy is performed, individuals will be informed via text messages about the foods and beverages that they can consume in their diet and those that are forbidden to consume until the morning of the colonoscopy, the amount of fluids they should consume daily, the use of medication, the use of soda and enema, appointment time reminders.
Primary Outcome Measure Information:
Title
Beck Anxiety Scale
Description
Beck Depression Scale (BDS) was developed by Beck. The scale was created to include clinical symptoms seen in depression. The items of the BDS are organized based on clinical observations and data. The scale consists of 21 symptom categories. Each symptom category is addressed with scored sentences ranging from 0-3. The maximum score that can be obtained from the scale is 63. A high total score on the scale indicates a high level or severity of depression
Time Frame
One day
Title
Boston Bowel Readiness Scale
Description
The scale has a four-point (0-3) scoring system applied separately for each of the three parts of the colon. 3- 0 (İnsuffıcıent) : Unprepared colon in which the mucosa cannot be evaluated due to uncleared solid fecal matter. (Bad) = Part of the mucosa is visible in the colon, but other parts are not visible due to contamination, residual fecal matter and/or opaque fluid. (Good) = Colon mucosa is well visualized but there is a small amount of impurities, small pieces of stool and/or opaque fluid. (Excellent) = The entire mucosa of the colon is well visible. No impurities, small pieces of pus or opaque fluid.
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals who understand Turkish Individuals who know how to use a phone and read text messages Individuals over 18 years of age Patients undergoing colonoscopy for the first time Exclusion Criteria: Patients with cognitive dysfunction Patients with neuro-psychiatric disorders Individuals who do not know how to use a phone Individuals undergoing colonoscopy in emergency situations Individuals who did not give consent to participate in the research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arif Murat ALAGÖZ
Phone
(0358)5134444
Email
murat540alagoz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neşe Uysal
Organizational Affiliation
Amasya U
Official's Role
Study Chair
Facility Information:
Facility Name
Amasya U
City
Amasya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neşe Uysal

12. IPD Sharing Statement

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Patient Education and Text Message Reminders in Colonoscopy

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