NCT06841991

Brief Summary

This study aims to evaluate the effect of the training given to the relatives of patients undergoing colonoscopy with the Teach-Back Method on anxiety and knowledge level. Research hypotheses: H1: The training given with the Teach-Back Method decreases the anxiety level of patient relatives. H2: The training provided with the Teach-Back Method increases the knowledge level of patient relatives.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

August 19, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

February 14, 2025

Last Update Submit

August 16, 2025

Conditions

Keywords

Colonoscopyteach-backanxietyeducation

Outcome Measures

Primary Outcomes (4)

  • Personal Information Form

    This form was prepared by the researchers in line with the literature and includes questions questioning the demographic characteristics of the patients' relatives such as age, gender, socioeconomic level, etc. This form will be used before the training

    10 minutes

  • Knowledge Question Form

    This form consists of questions that will measure the level of knowledge of the patients' relatives about the preparation that should be done before colonoscopy. A literature review will be conducted and 20 multiple-choice questions will be prepared by the researchers. Expert opinion will be obtained from a total of 5 faculty members working in the department of nursing principles in the preparation of this form. Then, the form will be finalised after the necessary arrangements are made. In the form consisting of multiple-choice questions with one correct answer, each question has a value of 5 points. Caregivers can get at least 0 and at most 100 points from the knowledge test. Increasing the score means that the knowledge is sufficient. Questions with incorrect answers are considered as topics to be prioritised in training. This form will be used before and after the training.

    20 minutes

  • State Anxiety Inventory

    This scale was developed by Spielberger and colleagues (1970). The scale was adapted into Turkish by Öner and Le Compte (1998). The scale consists of 20 questions and it is a scale that determines how the individual feels at a certain moment and condition. In the state anxiety scale, the response options collected in four classes are: (1) Not at all, (2) A little, (3) A lot and (4) Completely. The constant value for the State Anxiety Scale is 50. The scores obtained in the state anxiety scale theoretically vary between 20 and 80 points. In the evaluation of the scale, it is accepted that those who score below 36 have no anxiety, those who score between 37 and 42 have mild anxiety and those who score 42 and above have high anxiety. This form will be used before and after the training.

    10 minutes

  • Evaluation of Satisfaction with Teach-Back Method

    The relatives of the patients participating in the study will be asked to give a score between 1-10 in order to determine the level of satisfaction with the training provided by the teach-back method. It is defined as 1-not at all 10- very much and they will be asked to give full points. This form will be used after the training.

    5 minutes

Study Arms (2)

Teach back education group

EXPERIMENTAL

In the first stage, all participants will be explained about the research and their consent will be obtained. 'Personal Information Form' will be filled out for the relatives of the patients whose informed consents are obtained and who agree to participate in the study. Then, 'Information Questionnaire' and 'State Anxiety Scale' will be administered to all patient relatives as a pretest. In the second stage, the relatives of the patients who will undergo colonoscopy will be trained with the Teach-back technique. In the third stage, 'Information Questionnaire' and 'State Anxiety Scale' will be applied as posttest after the training. In addition, 'Satisfaction Evaluation of Teach-Back Method' will be performed.

Behavioral: Teach Back Education

Control Group

NO INTERVENTION

In the first stage, all participants will be explained about the research and their consent will be obtained. 'Personal Information Form' will be filled out for the relatives of the patients whose informed consents are obtained and who agree to participate in the study. Then, 'Information Questionnaire' and 'State Anxiety Scale' will be administered to all patient relatives as a pretest. No intervention will be made in the second stage. The routine process in the hospital will continue. In the third stage, 'Information Questionnaire' and 'State Anxiety Scale' will be administered to the relatives of the patients in both intervention and control groups as posttest after the training.

Interventions

The relatives of patients who will undergo colonoscopy will be trained with the teach-back technique.

Teach back education group

Eligibility Criteria

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

You may qualify if:

  • To have the ability to communicate verbally,
  • Volunteering to participate in the research,
  • To be 18 years of age or older.

You may not qualify if:

  • Lack of verbal communication skills,
  • Not volunteering to participate in the research,
  • Being under 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Mersin, Tarsus, Turkey (Türkiye)

Location

Related Publications (5)

  • Oh EG, Lee JY, Lee HJ, Oh S. Effects of discharge education using teach-back methods in patients with heart failure: A randomized controlled trial. Int J Nurs Stud. 2023 Apr;140:104453. doi: 10.1016/j.ijnurstu.2023.104453. Epub 2023 Feb 4.

    PMID: 36827745BACKGROUND
  • Oh EG, Lee HJ, Yang YL, Kim YM. Effectiveness of Discharge Education With the Teach-Back Method on 30-Day Readmission: A Systematic Review. J Patient Saf. 2021 Jun 1;17(4):305-310. doi: 10.1097/PTS.0000000000000596.

    PMID: 30882616BACKGROUND
  • Eloi H. Implementing teach-back during patient discharge education. Nurs Forum. 2021 Jul;56(3):766-771. doi: 10.1111/nuf.12585. Epub 2021 Apr 30.

    PMID: 33931873BACKGROUND
  • Choi S, Choi J. Effects of the teach-back method among cancer patients: a systematic review of the literature. Support Care Cancer. 2021 Dec;29(12):7259-7268. doi: 10.1007/s00520-021-06445-w. Epub 2021 Jul 24.

    PMID: 34302545BACKGROUND
  • Ahmadidarrehsima S, Bidmeshki EA, Rahnama M, Babaei K, Afshari M, Khandani BK. The Effect of Self-Management Education by the Teach-Back Method on Uncertainty of Patients with Breast Cancer: a Quasi-Experimental Study. J Cancer Educ. 2020 Apr;35(2):366-372. doi: 10.1007/s13187-019-1474-5.

    PMID: 30680649BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 24, 2025

Study Start

June 1, 2025

Primary Completion

September 30, 2025

Study Completion

October 31, 2025

Last Updated

August 19, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations