NCT04895813

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

May 8, 2021

Last Update Submit

October 24, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Group 1:

EXPERIMENTAL

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

Group 2

NO INTERVENTION

Routine information in the service will be made

Interventions

EducationBEHAVIORAL

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

Also known as: Gudiance
Group 1:

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan Univercity

Konya, 42370, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
NO MASKING
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Open label posttest controlled parallel group randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assit. Prof.

Study Record Dates

First Submitted

May 8, 2021

First Posted

May 20, 2021

Study Start

July 1, 2022

Primary Completion

March 30, 2023

Study Completion

May 1, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations