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NCT Number: NCT07489261

Effect of Mobile Application- and AI 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. . 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%, 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mersin Unıversıty

Mersin, Turkey (Türkiye)

Location status: Recruiting

Location contact

ERİM ERDEM

PRINCIPAL_INVESTIGATOR

Elife Kettaş dölek

CONTACT

[email protected]

GAMZE BOZKUL

CONTACT

[email protected]

GÜLAY ALTUN UĞRAŞ

PRINCIPAL_INVESTIGATOR

MERT BAŞARANOĞLU

PRINCIPAL_INVESTIGATOR

About this study

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% , 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile application

Other

Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1)

Artifial intellgience

Other

Patients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2)

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ELİFE KETTAŞ DÖLEK, Principal İnvestigator

CONTACT

ELİFE KETTAŞ DÖLEK, Prinicipal İnvestigator

CONTACT

[email protected]

03242410000

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

Effect of Mobile Application- and Artificial Intelligence-Supported Video-Based Patient Education on Patient Outcomes in Teaching Clean Intermittent Catheterization

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.