HealthyNCT06841991
Effect of Teach-Back Method in Colonoscopy
A study testing Teach Back Education in people with Healthy, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Teach Back Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To have the ability to communicate verbally,
- Volunteering to participate in the research,
- To be 18 years of age or older.
Who cannot join
- Lack of verbal communication skills,
- Not volunteering to participate in the research,
- Being under 18 years old.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of TeachBack Method on Anxiety and Knowledge Level of Relatives of Patients to Undergo Colonoscopy: A Randomised Controlled Study
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.
Read the detailed description
Teach-back technique is an effective educational method that enables a person to rephrase what he/she has learnt in his/her own words to show that he/she understands. There is no study evaluating the effect of the education to be given with the Teach-back technique to the relatives of patients who will undergo colonoscopy. In addition, in this study, anxiety and knowledge levels of the relatives of the patients before and after the training will be discussed and will be a guide for future studies. The training to be given with the Teach-back technique will increase the level of knowledge of the patient's relatives and ensure that they know what to expect at every stage of the procedure. At the end of the study, the participants will be asked about their level of satisfaction with the Teach-back technique. According to the results of the study, it is expected that the use of Teach-back technique in the education of patients and their relatives will increase.
- Conditions
- Healthy
- Being tested
- Teach Back Education
- Keywords
- Colonoscopy, teach-back, anxiety, education
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach Back EducationBehavioural
The relatives of patients who will undergo colonoscopy will be trained with the teach-back technique.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Jun 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadiye BARIŞ EREN, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841991
- Sponsor's protocol ID
- TarsusU-NBARISEREN-002
- Status last verified
- Jul 2025
- First submitted
- 14 Feb 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36827745Oh 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.
PubMed 30882616Eloi 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.
PubMed 33931873Choi 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.
PubMed 34302545Ahmadidarrehsima 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.
PubMed 30680649
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of TeachBack Method on Anxiety and Knowledge Level of Relatives of Patients to Undergo Colonoscopy: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06841991
- Acronym / sponsor ID
- TarsusU-NBARISEREN-002
- Conditions
- Healthy
- Keywords
- Colonoscopy, teach-back, anxiety, education
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Teach-back technique is an effective educational method that enables a person to rephrase what he/she has learnt in his/her own words to show that he/she understands. There is no study evaluating the effect of the education to be given with the Teach-back technique to the relatives of patients who will undergo colonoscopy. In addition, in this study, anxiety and knowledge levels of the relatives of the patients before and after the training will be discussed and will be a guide for future studies. The training to be given with the Teach-back technique will increase the level of knowledge of the patient's relatives and ensure that they know what to expect at every stage of the procedure. At the end of the study, the participants will be asked about their level of satisfaction with the Teach-back technique. According to the results of the study, it is expected that the use of Teach-back technique in the education of patients and their relatives will increase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teach back education group | Experimental | Behavioral: Teach Back EducationIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To have the ability to communicate verbally,
- Volunteering to participate in the research,
- To be 18 years of age or older.
Key exclusion criteria (3 listed)
- Lack of verbal communication skills,
- Not volunteering to participate in the research,
- Being under 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teach Back EducationThe relatives of patients who will undergo colonoscopy will be trained with the teach-back technique. | Behavioural | Teach back education group |
Primary outcome
Personal Information Form
Time frame: 10 minutes
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
Knowledge Question Form
Time frame: 20 minutes
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.
State Anxiety Inventory
Time frame: 10 minutes
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.
Evaluation of Satisfaction with Teach-Back Method
Time frame: 5 minutes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 36827745Oh 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.
- Background: PubMed 30882616Oh 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.
- Background: PubMed 33931873Eloi 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.
- Background: PubMed 34302545Choi 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.
- Background: PubMed 30680649Ahmadidarrehsima 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach Back Education in people with Healthy, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06841991, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.