- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07489261
Effect of Mobile Application- and AI Supported Video-Based Patient Education on Patient Outcomes in Teaching Clean Intermittent Catheterization
March 19, 2026 updated by: Elife Kettas Dolek, Mersin University
Effect of Mobile Application- and Artificial Intelligence-Supported Video-Based Patient Education on Patient Outcomes in Teaching Clean Intermittent Catheterization
The study aimed to determine the effects of a mobile application and an artificial intelligence-supported educational video, developed for patients who will perform clean intermittent catheterization (CIC), on patients' adherence, levels of difficulty, self-confidence, infection parameters (urinalysis, urine culture, infection incidence), and recurrent hospital admissions.The number of CIC patients who applied to the Urology Outpatient Clinic of Mersin University within the last year was 110.
Since no similar study was found, the sample size was calculated using an a priori power analysis with G*Power 3.1.9.7 software.
For the one-way analysis of variance (ANOVA), the parameters used were α error probability = 0.05, power (1-β error probability) = 0.80, number of groups = 3, and effect size f = 0.40 (large effect size).
As a result of the power analysis, the total sample size was calculated as 90, with 30 participants in each group.
Considering a possible data loss (dropout) rate of approximately 10% (Hernández-Rodríguez et al., 2022), it was planned to include 33 participants in each group (a total of 99 participants) at the beginning of the study.Data will be collected using the "Descriptive Information Form," "Intermittent Catheterization Adherence Scale," "Self-Confidence Scale in Clean Intermittent Self-Catheterization," "Intermittent Catheterization Difficulty Questionnaire," and the "Patient Follow-up Form."Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1) and an artificial intelligence-supported educational video (intervention group 2).
Patients in the control group will be trained using the routine brochure provided in the outpatient clinic.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The study was designed as a prospective, three-arm (1:1:1), randomized controlled clinical trial.
The study will be conducted at the Urology Outpatient Clinic of Mersin University Faculty of Medicine Hospital.
The Urology Outpatient Clinic includes adult and pediatric outpatient units, an intervention room, an ultrasound room, an andrology laboratory, a lithotripsy unit, and a urodynamics unit.
The Department of Urology consists of seven faculty members and 11 research assistants.
In the urology outpatient clinic, there is one nurse, two technicians, two secretaries, and one cleaning staff member.
Outpatient services are provided between 08:00 and 17:00, and clean intermittent catheterization (CIC) training is also delivered to patients during these hours.
The nurse provides training to patients who will perform CIC using a brochure.
After the training, patients routinely return to the outpatient clinic for follow-up visits on the 15th day and at the 3rd month.
study aimed to determine the effects of a mobile application and an artificial intelligence-supported educational video, developed for patients who will perform clean intermittent catheterization (CIC), on patients' adherence, levels of difficulty, self-confidence, infection parameters (urinalysis, urine culture, infection incidence), and recurrent hospital admissions.The number of CIC patients who applied to the Urology Outpatient Clinic of Mersin University within the last year was 110.
Since no similar study was found, the sample size was calculated using an a priori power analysis with G*Power 3.1.9.7 software.
For the one-way analysis of variance (ANOVA), the parameters used were α error probability = 0.05, power (1-β error probability) = 0.80, number of groups = 3, and effect size f = 0.40 (large effect size).
As a result of the power analysis, the total sample size was calculated as 90, with 30 participants in each group.
Considering a possible data loss (dropout) rate of approximately 10% (Hernández-Rodríguez et al., 2022), it was planned to include 33 participants in each group (a total of 99 participants) at the beginning of the study.Data will be collected using the "Descriptive Information Form," "Intermittent Catheterization Adherence Scale," "Self-Confidence Scale in Clean Intermittent Self-Catheterization," "Intermittent Catheterization Difficulty Questionnaire," and the "Patient Follow-up Form."Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1) and an artificial intelligence-supported educational video (intervention group 2).
Patients in the control group will be trained using the routine brochure provided in the outpatient clinic.
Study Type
Interventional
Enrollment (Estimated)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ELİFE KETTAŞ DÖLEK, Prinicipal İnvestigator
- Phone Number: 03242410000
- Email: elifeket@yahoo.com
Study Contact Backup
- Name: ELİFE KETTAŞ DÖLEK, Principal İnvestigator
Study Locations
-
-
-
Mersin, Turkey (Türkiye)
- Mersin Unıversıty
-
Principal Investigator:
- GÜLAY ALTUN UĞRAŞ
-
Contact:
- ELİFE KETTAŞ DÖLEK
- Email: elifeket@yahoo.com
-
Contact:
- GAMZE BOZKUL
- Email: gamze.bozkul@gmail.com
-
Principal Investigator:
- ERİM ERDEM
-
Principal Investigator:
- MERT BAŞARANOĞLU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients who require intermittent catheterization (TAK),
- Aged 18 years or older,
- Willing to participate in the study,
- Able to understand Turkish,
- Literate,
- Without visual or hearing impairments,
- Owning a smartphone, tablet, or computer,
- Without difficulties using technology.
Exclusion Criteria:
- Patients who do not require intermittent catheterization (TAK),
- Under 18 years of age,
- Not willing to participate in the study,
- Do not understand Turkish,
- Illiterate,
- With visual or hearing impairments,
- Do not own a smartphone, tablet, or computer,
- Having difficulties using technology.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group: Mobile application group
Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1)
|
Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1)
|
|
Experimental: Experimental group: Artificial intelligent video group
Patients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2).
|
Patients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2)
|
|
No Intervention: Control group
Patients in the control group will be trained using the routine brochure provided in the outpatient clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence
Time Frame: 6 months
|
The Intermittent Catheterization Adherence Scale was developed by Amandine Guinet-Lacoste and colleagues in 2018, and its Turkish adaptation and reliability study were conducted by Duman in 2021.
The first seven items of the scale (except the fifth item) are scored as "Yes = 1" and "No = 0," while the fifth item is scored in reverse: "Yes = 0" and "No = 1."
The eighth item uses a 5-point Likert scale, scored as "Never = 0," "Sometimes = 0.25," "Often = 0.50," "Most of the time = 0.75," and "Always = 1."
The total score of the scale is calculated out of 8, with the resulting scores reflecting patients' adherence to catheterization.
Accordingly, a score of 0 indicates "high adherence," 1-2 points indicate "moderate adherence," and 3-8 points indicate "low adherence."
The Cronbach's alpha coefficient, indicating internal consistency of the scale, is 0.73.
|
6 months
|
|
Self-Confidence
Time Frame: 6 months
|
This scale was developed by Biaziolo and colleagues in 2017.
The Turkish adaptation, validity, and reliability study was conducted by Çulha and Acaroğlu in 2020.
The scale, which has a five-point Likert-type structure, consists of short statements that assess the steps of catheterization and the individual's self-confidence in performing this procedure.
The response options are as follows: 1 = Not confident, 2 = Slightly confident, 3 = Confident, 4 = Very confident, 5 = Completely confident.
The scale consists of a total of 16 items.
The total score is calculated by summing the numerical values of the responses to all items, and the total score ranges from 0 to 64.
Higher scores indicate a higher level of self-confidence in performing catheterization.
The internal consistency of the scale was found to be quite high, with a total Cronbach's alpha coefficient of 0.89.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: GAMZE BOZKUL, Tarsus University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bobian, M., Kandinov, A., El Kashlan, N., Svider, P. F., Folbe, A. J., Mayerhoff, R., Eloy, J. A., & Raza, S. N. (2017). Mobile applications and patient education: Are currently available GERD mobile apps sufficient? The Laryngoscope, 127(8), 1775-1779. https://doi.org/10.1002/lary.26341
- Cerantola, Y., Valerio, M., Persson, B., Jichlinski, P., Ljungqvist, O., Hubner, M., Kassouf, W., Müller, S., Baldini, G., Carli, F., Næsheimh, T., Ytrebø, L., Revhaug, A., Lassen, K., Knutsen, T., Aarsether, E., Wiklund, P., & Patel, H. R. (2013). Guidelines for perioperative care after radical cystectomy for bladder cancer: Enhanced Recovery After Surgery (ERAS®) society recommendations. Clinical Nutrition, 32(6), 879-887. https://doi.org/10.1016/j.clnu.2013.09.014
- Bhuyan, S. S., Sateesh, V., Mukul, N., Galvankar, A., Mahmood, A., Nauman, M., Rai, A., Bordoloi, K., Basu, U., & Samuel, J. (2025). Generative Artificial Intelligence Use in Healthcare: Opportunities for Clinical Excellence and Administrative Efficiency. Journal of Medical Systems, 49(1), 10. https://doi.org/10.1007/s10916-024-02136-1
- Hernández-Rodríguez, J. C., García-Muñoz, C., Ortiz-Álvarez, J., Saigí-Rubió, F., Conejo-Mir, J., & Pereyra-Rodriguez, J. J. (2022). Dropout Rate in Digital Health Interventions for the Prevention of Skin Cancer: Systematic Review, Meta-analysis, and Metaregression. Journal of medical Internet research, 24(12), e42397. https://doi.org/10.2196/42397
- Alasker, A., Alsalamah, S., Alshathri, N., Almansour, N., Alsalamah, F., Alghafees, M., AlKhamees, M., & Alsaikhan, B. (2024). Performance of large language models (LLMs) in providing prostate cancer information. BMC Urology, 24(1), 177. https://doi.org/10.1186/s12894-024-01570-0
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
December 15, 2026
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
March 19, 2026
First Submitted That Met QC Criteria
March 19, 2026
First Posted (Actual)
March 24, 2026
Study Record Updates
Last Update Posted (Actual)
March 24, 2026
Last Update Submitted That Met QC Criteria
March 19, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- MU-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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