Patient EducationNCT04895813
The Effect of Education and Telephone Guidance at Colonoscopy
A study testing Education in people with Patient Education and Guidance, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Education, Guidance, Colonoscopy
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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%.
- Conditions
- Patient Education, Guidance, Colonoscopy, Nursing
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Also called Gudiance
The patient will be given pre-colonoscopy training and guidance by telephone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education |
| Group 2 | No intervention | Routine information in the service will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: immediately after the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Jul 2022
- Primary completion30 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EducationStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label posttest controlled parallel group randomized controlled study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Burucu, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895813
- Sponsor's protocol ID
- Necmettin ErbakanU
- Status last verified
- Oct 2023
- First submitted
- 8 May 2021
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be decided upon completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04895813
- Acronym / sponsor ID
- Necmettin ErbakanU
- Conditions
- Patient Education, Guidance, Colonoscopy, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 20 May 2021 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label posttest controlled parallel group randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Group 1: | Experimental | Behavioral: EducationThe 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. |
| Group 2 | No intervention | –Routine information in the service will be made |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| EducationAlso: GudianceThe patient will be given pre-colonoscopy training and guidance by telephone. | Behavioural | Group 1: |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: Undecided. It will be decided upon completion of the study.
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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. This study is not recruiting at the moment.
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 Education in people with Patient Education and Guidance, run by Necmettin Erbakan 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 25 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The patient's anxiety level is low (time frame: Just before the colonoscopy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2023.