Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06429631 |
Other study ID # |
77082166-302.08.01-424987 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 15, 2023 |
Est. completion date |
August 31, 2024 |
Study information
Verified date |
May 2024 |
Source |
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Neurogenic bladder is a condition that occurs due to nerve damage or congenital problems and
causes urination disorders. Nowadays, in individuals diagnosed with neurogenic bladder, Clean
Intermittent Catheterization is often used to evacuate the urine accumulated in the bladder.
Clean Intermittent Catheterization(CIC) is a simple, safe and effective method in which the
catheter is placed through the meatus. In this application, the catheter is removed without
waiting after urine drainage is achieved. This process is usually performed on its own. Since
IC(Intermittent Catheterization) is a procedure performed on the bladder, it may cause some
complications. IC application must be performed successfully to prevent or reduce
complications. The success of the technique largely depends on patient education and
follow-up. Sometimes patients may not be able to come to the hospital for follow-up and
feedback after IC training.
Innovations are needed to ensure the continuation of distance education so that the education
of patients who cannot come to the hospital is not incomplete. The literature includes
brochures, videos, websites and some mobile applications for IC training. However, no
application has been found that monitors patients' urine amounts.
This research was planned to examine the effect of clean intermittent catheterization
training given via mobile application to individuals with spinal cord injury on their quality
of life and compliance.
Description:
scales:
1. Information form: Authors will ask to patients age, weight, height, gender, marital
status, education level, diagnosis, time of injury, cause of injury, independence level,
working or not working, presence of spasticity, presence of complications
2. WHOQOL-BREF(World Health Organization Quality of Life Scale):The WHO Quality of Life
Assessment (WHOQOL) is a generic quality of life instrument that was designed to be
applicable to people living under different circumstances, conditions, and cultures. The
short version known as WHOQOL-BREF with 26 items. It is based on a Likert-type scale and
is scored from 1 to 5, with higher scores indicating a better quality of life.
3. Intermittent Self-Catheterization Questionnaire (ISC-Q): This is a 24-item
self-administered questionnaire. Each item is scored on a 5-point Likert-type scale
ranging from 0 (strongly disagree) to 4 (strongly agree), and after the conversion of
the 14 reverse-coded items to give a common range of 0-100, the scores are calculated by
multiplying the mean value of all items within each domain by 25. The total ISC-Q score
is then calculated from the simple average from across the four domains (0-100), with
higher scores indicating a higher quality of life.
4. Intermittent Catheterization Adherence Scale (ICAS): ICAS (IntermittentCatheterization
Adherence Scale) is used to assess long-term patient adherence to prescribed ISC
treatment. Binary answers were used for the first seven questions:yes = 1, no = 0,
whereas the response options for the eighth question were graded on a 5-point
Likert-type scale: 0 indicating "never," 0.25 "sometimes," 0.5 "often,"0.75 "regularly,"
and 1 "always," leading to a maximum possible score of 8. A patient's score is
empirically classified into three intervals: strong adherence = 0; average adherence =
1-2; low adherence = 3-8.
5. Mobile Application Usability Scale (MAUS): The scale measures mobile application
usability which is formed with 10 constructs/factors which includes four items each (40
items at total). The scale measures using a 7-point Likert-type scale (1=strongly
disagreeā¦7=strongly agree)