Intermittent Urethral CatheterizationNCT04763382
The Effect of Nursing Interventions for Clean Intermittent Catheterization Caregivers and Child
A study testing experimental group: Training of caregivers in people with Intermittent Urethral Catheterization and Spinal Dysraphism, run by Karadeniz Technical University at 2 sites in Turkey (Türkiye).
Trial summary
In neurogenic or non-neurogenic bladder disorders, the removal process after the catheter is inserted into the bladder and the urine has been drained is called Clean intermittent catheterization (CIC). After 1972, Lapides started using CIC in the treatment of people who cannot empty their bladder on their own. Read more about this study
- Who is it for?
- Ages 27 days to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Urethral Catheterization, Spinal Dysraphism, Urinary Tract Infections
- What is being tested?
- experimental group: Training of caregivers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 23 Mar 2020to 25 May 2021
- 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 27 days to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Volunteering to participate in the study
- Being literate
- Having a smart phone with an android application
- He should not have received information from the nurse about CIC application.
- The children included in our research;
- Between the ages of 0-17
- Karadeniz Technical University Farabi Hospital Pediatric Nephrology Department decided to apply and implement CIC
- It should not have a complex congenital anatomical anomaly of the urogenital system
Who cannot join
- Being 18 years old and above
- Being a communication problems
- Having mental confusion or any psychiatric problem caregiver
- Not volunteering to participate in the research
- Not have androıd smart phone
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Karadeniz Techical University Health Faculty of Health Sciences
Trabzon, Health Faculty of Health Sciences, 61080
Karadeniz Technıcal University
Trabzon, Health Faculty of Health Sciences, 61080
About this study
Official title: The Effect of Nursing Interventions for Clean Intermittent Catheterization on Knowledge / Skills, Coping / Adaptation, Anxiety and Infection Development in Child Caregivers
In neurogenic or non-neurogenic bladder disorders, the removal process after the catheter is inserted into the bladder and the urine has been drained is called Clean intermittent catheterization (CIC). After 1972, Lapides started using CIC in the treatment of people who cannot empty their bladder on their own. The decision to apply CIC to patients is made by the doctor. After CIC application, patients's increase body image, self-confidence development and quality of life. CIC application to children is done by caregivers. CIC use has negative effects as well as positive effects for patients. If the caregiver has not received enough training about CIC application and does not pay attention to CIC performing hours and procedure steps, urinary tract infection can be seen in children. Common urinary tract infections in children cause permanent kidney damage. Studies conducted to prevent complications that may develop in patients using CIC emphasize the importance of patient education. The aim of this study is to evaluate the effect of based on the roy adaptation theory supported android phone application CIC training, on the knowledge / skills, coping / adaptation and anxiety level of caregivers and the development of urinary tract infection in children.
Read the detailed description
Background: It is the bladder, one of the organs with important functions in the urinary system. However, the bladder sometimes cannot work effectively as a result of neurological and sometimes non-neurological reasons. After this situation, urine in the bladder should be emptied. The bladder is one of the most frequently used organs in the urinary system. In neurogenic or non-neurogenic bladder disorders, the process of entering the bladder with a catheter in clean conditions, evacuating urine, and then removing the catheter is called Clean Intermittent Catheterization (CIC). CIC has been used by patients for nearly 40 years. CIC is one of the effective methods used to protect the urinary system, especially in children with Spina Bifida and people with urinary system problems. CIC application to children is done by caregivers. In the education of caregivers who have to apply CIC to their child the role of nurse to become more and more important. The aim of this study is to evaluate the effect of based on the roy adaptation theory supported android phone application CIC training, on the knowledge / skills, coping / adaptation and anxiety level of caregivers and the development of urinary tract infection in children.
Metod: The universe of the study consisted of the patients and their caregivers who were decided to perform CIC by Karadeniz Technical University Farabi Hospital Pediatric Nephrology Department. In order to determine the sample of the study, the test power in power analysis was calculated with the G * Power 3.1 program. 95% confidence interval in determining the strength of the study; With 5% significance level and 0.50 effect size a total of 36 patients (df = 1; F = 4.130). 36 conforming patients were divided into experimental and control groups for a single- blind randomized control. The data will be collected using the introductory information form, the CIC application knowledge and skills form, based on North American Association of Nursing Diagnoses (NANDA) nursing diagnoses and Psychosocial Adaptation Area of Roy Adaptation Model form, Coping and Adaptation Scale and State Trait Anxiety Scale. In addition, for the diagnosis of urinary tract infection in participants undergoing CIC, urinalysis will be performed once a month, three times for three months. Patients with 100,000 colonies per milliliter of urine for urinalysis will be considered to have a urinary tract infection. No additional intervention will be made to caregivers in the control groups. Caregivers in the intervention group (Caregivers who will receive CIC training supported by Android phone application based on Roy adaptation model) will be given CIC training, home visit, and telephone conversation. In addition, an android phone application will be installed on the phones of the caregivers in the intervention group, which reminds the CIC times, procedure steps and hospital appointments. The data will be analyzed using SPSS versiyon with descriptive statistics, Independent t test and Anova in repeated measurements p<0.05 will be statistically significant
- Being tested
- experimental group: Training of caregivers, Control gruop
- Keywords
- Anxiety, Child, Nurses, Urinary Tract Infection, Intermittent Urethral Catheterization, Quality of Life, Caregivers, Mobile Applications, Smartphone
- Medical subject headings
- Spinal Dysraphism, Urinary Tract Infections, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental group: Training of caregiversOther
Pre-test, post-test, retention test, education, guide booklet delivery, android application installation and urinalysis
Control gruopOther
Pre-test, post-test and urinalysis
| Study group | Role | What they receive |
|---|---|---|
| Experimental grups: Training of caregivers | Other | 1. Application of data collection:
Tools as pre-test, post-test and retention test to participants in the experimental group,
2. Education:It includes the training given to the caregivers in the experimental group, delivery of the guide booklet at the end of the training
3. Android phone application: Installing on the phones of the caregivers in the experimental group of the android application, which includes the frequency of CIC application, the CIC application process steps and hospital appointments, created by the nurse for the caregivers in the experimental group and the software is made by the computer engineer.
4. One home visit and three phone calls were made in order to solve the problems that the caregivers in the experimental group experienced with the use of CIC or android use.
5. Urinalysis for children who are inserted and put into the study:All participants in the study were asked to give urine tests three times with an interval of one month after discharge. Receives: Other: experimental group: Training of caregivers |
| Control: Control grups | Other | 1. As in the experimental group, the caregivers in the control group were pre-tested and post-tested using data collection tools.
2. No intervention was made to the caregivers in the control group.
3. However, caregivers in the control group performed urinalysis three times with an interval of one month after discharge. Receives: Other: Control gruop |
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge / skill level of caregivers.
The data collection tool used is not a scale. Created by researchers in line with the literature
Measured: Change from knowledge / skill level of caregivers at 3 months
The coping / adaptation scala of the caregivers.
Çatal in 2015. The Coping and Adaptation Processing Scale (CAPS) is a 47-item instrument using a Likert scale format with response choices ranging from 4 (always) to 1 (never). Each item of the CAPS is a short statement about how an individual responds to experiencing a crisis or extremely difficult event. Fourteen items are reversed scored. The possible range of scores is from 47 to 188 with a high score indicating a more consistent use of the identified strategies of coping.
Measured: Change from the coping / adaptation level of caregivers at 2 months
Anxiety Level of caregivers
State and Trait Anxiety Scale (STAI) will be used to assess the anxiety levels of caregivers. The scale was created in 1964 by Speilberger and Gorsuch. The scale was adapted to Turkish in 1975 by Öner and Le Compte. The scale consists of two parts, each consisting of 20 items. the first part is the state anxiety scale part. Grouped as (1) None, (2) A little, (3) Much, and (4) All. There are ten reversed statements in the state anxiety scale. These are Articles 1, 2,5, 8, 10, 11, 15, 16, 19 and 20. Trait Anxiety Scale is the second part of the scale. Grouped as (1) Almost never, (2) Sometimes, (3) A lot of time, and (4) Almost always. Reversed on the trait anxiety scale there are expressions. These statements are 21, 26, 27, 30, 33, 36 and 39. The scores obtained from each scale range from 20 to 80. The higher the scores obtained from the scale, the higher the anxiety level.
Measured: Change from anxiety level of caregivers at 2 months
Urinary infection in the child.
Urine analysis will be performed to evaluate the development of urinary tract infection in children undergoing CIC.The diagnosis of urinary tract infection in children will be made in accordance with the literature with the presence of 100,000 colony bacteria in the urine.
Measured: Change from Urinary infection in the child at 2 months
Roy adaptatıon model question form
Question form created by adhering to NANDA-I nursing diagnoses based on the concepts in the Roy Adaptation Model and the stimuli in the model.The data collection tool used is not a scale. Created by researchers in line with the literature
Measured: Change from at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start23 Mar 2020
- Primary completion20 Jun 2020
- Study completion25 May 2021 (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 Intermittent Urethral CatheterizationStudies 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
- Model description
- The caregivers in experimental group of study were given health training on CIC application, and after the training, the guide booklet was delivered to the participants, the android phone application. After discharge of three urinalysis, three phone calls and home visit. The data collection tools applied to aregivers in experimental group as a pre-test were also applied post-test and retention test. The same data collection tools were applied to control group for pre-test. The caregivers in the control group were not trained, android applications were not installed on their phones, home visits. With the routine practice given in the hospital, he was provided with CIC training. However, one month after discharge, he was asked to give urinalysis once a month for three consecutive months. Urinalysis was taken three times in total. Data collection tools, which were applied as a pre-test when they gave the second urinalysis, were applied again as a post-test.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Sari, Karadeniz Technical University
- Investigators
- CANAN SARI, PhD student, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763382
- Sponsor's protocol ID
- Nurse_clean intermittent cat.
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not want to share my individual participant data with other participants, as I have not completed my work yet.
Publications
Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available.
PubMed 20156062Lapides J, Diokno AC, Gould FR, Lowe BS. Further observations on self-catheterization. J Urol. 1976 Aug;116(2):169-71. doi: 10.1016/s0022-5347(17)58730-3.
PubMed 950697Singh R, Rohilla RK, Sangwan K, Siwach R, Magu NK, Sangwan SS. Bladder management methods and urological complications in spinal cord injury patients. Indian J Orthop. 2011 Mar;45(2):141-7. doi: 10.4103/0019-5413.77134.
PubMed 21430869Neveus T, von Gontard A, Hoebeke P, Hjalmas K, Bauer S, Bower W, Jorgensen TM, Rittig S, Walle JV, Yeung CK, Djurhuus JC. The standardization of terminology of lower urinary tract function in children and adolescents: report from the Standardisation Committee of the International Children's Continence Society. J Urol. 2006 Jul;176(1):314-24. doi: 10.1016/S0022-5347(06)00305-3.
PubMed 16753432Sari C, Demirbag BC. The effect of model-based android phone application supported clean intermittent catheterization training on caregivers and children: A randomized controlled study. Eur J Pediatr. 2024 Nov 27;184(1):46. doi: 10.1007/s00431-024-05890-z.
PubMed 39601932
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Interventions for Clean Intermittent Catheterization on Knowledge / Skills, Coping / Adaptation, Anxiety and Infection Development in Child Caregivers
- ClinicalTrials.gov ID
- NCT04763382
- Acronym / sponsor ID
- Nurse_clean intermittent cat.
- Keywords
- Anxiety, Child, Nurses, Urinary Tract Infection, Intermittent Urethral Catheterization, Quality of Life, Caregivers, Mobile Applications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 25 May 2021 (estimated)
- First posted
- 21 Feb 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.
In neurogenic or non-neurogenic bladder disorders, the removal process after the catheter is inserted into the bladder and the urine has been drained is called Clean intermittent catheterization (CIC). After 1972, Lapides started using CIC in the treatment of people who cannot empty their bladder on their own. The decision to apply CIC to patients is made by the doctor. After CIC application, patients's increase body image, self-confidence development and quality of life. CIC application to children is done by caregivers. CIC use has negative effects as well as positive effects for patients. If the caregiver has not received enough training about CIC application and does not pay attention to CIC performing hours and procedure steps, urinary tract infection can be seen in children. Common urinary tract infections in children cause permanent kidney damage. Studies conducted to prevent complications that may develop in patients using CIC emphasize the importance of patient education. The aim of this study is to evaluate the effect of based on the roy adaptation theory supported android phone application CIC training, on the knowledge / skills, coping / adaptation and anxiety level of caregivers and the development of urinary tract infection in children.
Detailed description
Background: It is the bladder, one of the organs with important functions in the urinary system. However, the bladder sometimes cannot work effectively as a result of neurological and sometimes non-neurological reasons. After this situation, urine in the bladder should be emptied. The bladder is one of the most frequently used organs in the urinary system. In neurogenic or non-neurogenic bladder disorders, the process of entering the bladder with a catheter in clean conditions, evacuating urine, and then removing the catheter is called Clean Intermittent Catheterization (CIC). CIC has been used by patients for nearly 40 years. CIC is one of the effective methods used to protect the urinary system, especially in children with Spina Bifida and people with urinary system problems. CIC application to children is done by caregivers. In the education of caregivers who have to apply CIC to their child the role of nurse to become more and more important. The aim of this study is to evaluate the effect of based on the roy adaptation theory supported android phone application CIC training, on the knowledge / skills, coping / adaptation and anxiety level of caregivers and the development of urinary tract infection in children.
Metod: The universe of the study consisted of the patients and their caregivers who were decided to perform CIC by Karadeniz Technical University Farabi Hospital Pediatric Nephrology Department. In order to determine the sample of the study, the test power in power analysis was calculated with the G * Power 3.1 program. 95% confidence interval in determining the strength of the study; With 5% significance level and 0.50 effect size a total of 36 patients (df = 1; F = 4.130). 36 conforming patients were divided into experimental and control groups for a single- blind randomized control. The data will be collected using the introductory information form, the CIC application knowledge and skills form, based on North American Association of Nursing Diagnoses (NANDA) nursing diagnoses and Psychosocial Adaptation Area of Roy Adaptation Model form, Coping and Adaptation Scale and State Trait Anxiety Scale. In addition, for the diagnosis of urinary tract infection in participants undergoing CIC, urinalysis will be performed once a month, three times for three months. Patients with 100,000 colonies per milliliter of urine for urinalysis will be considered to have a urinary tract infection. No additional intervention will be made to caregivers in the control groups. Caregivers in the intervention group (Caregivers who will receive CIC training supported by Android phone application based on Roy adaptation model) will be given CIC training, home visit, and telephone conversation. In addition, an android phone application will be installed on the phones of the caregivers in the intervention group, which reminds the CIC times, procedure steps and hospital appointments. The data will be analyzed using SPSS versiyon with descriptive statistics, Independent t test and Anova in repeated measurements p<0.05 will be statistically significant
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The caregivers in experimental group of study were given health training on CIC application, and after the training, the guide booklet was delivered to the participants, the android phone application. After discharge of three urinalysis, three phone calls and home visit. The data collection tools applied to aregivers in experimental group as a pre-test were also applied post-test and retention test. The same data collection tools were applied to control group for pre-test. The caregivers in the control group were not trained, android applications were not installed on their phones, home visits. With the routine practice given in the hospital, he was provided with CIC training. However, one month after discharge, he was asked to give urinalysis once a month for three consecutive months. Urinalysis was taken three times in total. Data collection tools, which were applied as a pre-test when they gave the second urinalysis, were applied again as a post-test.
| Arm | Type | Receives |
|---|---|---|
| Experimental grups: Training of caregivers | Other | Other: experimental group: Training of caregivers1. Application of data collection: Tools as pre-test, post-test and retention test to participants in the experimental group, 2. Education:It includes the training given to the caregivers in the experimental group, delivery of the guide booklet at the end of the training 3. Android phone application: Installing on the phones of the caregivers in the experimental group of the android application, which includes the frequency of CIC application, the CIC application process steps and hospital appointments, created by the nurse for the caregivers in the experimental group and the software is made by the computer engineer. 4. One home visit and three phone calls were made in order to solve the problems that the caregivers in the experimental group experienced with the use of CIC or android use. 5. Urinalysis for children who are inserted and put into the study:All participants in the study were asked to give urine tests three times with an interval of one month after discharge. |
| Control: Control grups | Other | Other: Control gruop1. As in the experimental group, the caregivers in the control group were pre-tested and post-tested using data collection tools. 2. No intervention was made to the caregivers in the control group. 3. However, caregivers in the control group performed urinalysis three times with an interval of one month after discharge. |
Who may qualify
- Ages
- 27 days to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Volunteering to participate in the study
- Being literate
- Having a smart phone with an android application
- He should not have received information from the nurse about CIC application.
- The children included in our research;
Key exclusion criteria (5 listed)
- Being 18 years old and above
- Being a communication problems
- Having mental confusion or any psychiatric problem caregiver
- Not volunteering to participate in the research
- Not have androıd smart phone
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 |
|---|---|---|
| experimental group: Training of caregiversPre-test, post-test, retention test, education, guide booklet delivery, android application installation and urinalysis | Other | Experimental grups: Training of caregivers |
| Control gruopPre-test, post-test and urinalysis | Other | Control: Control grups |
Primary outcome
knowledge / skill level of caregivers.
Time frame: Change from knowledge / skill level of caregivers at 3 months
The data collection tool used is not a scale. Created by researchers in line with the literature
The coping / adaptation scala of the caregivers.
Time frame: Change from the coping / adaptation level of caregivers at 2 months
Çatal in 2015. The Coping and Adaptation Processing Scale (CAPS) is a 47-item instrument using a Likert scale format with response choices ranging from 4 (always) to 1 (never). Each item of the CAPS is a short statement about how an individual responds to experiencing a crisis or extremely difficult event. Fourteen items are reversed scored. The possible range of scores is from 47 to 188 with a high score indicating a more consistent use of the identified strategies of coping.
Anxiety Level of caregivers
Time frame: Change from anxiety level of caregivers at 2 months
State and Trait Anxiety Scale (STAI) will be used to assess the anxiety levels of caregivers. The scale was created in 1964 by Speilberger and Gorsuch. The scale was adapted to Turkish in 1975 by Öner and Le Compte. The scale consists of two parts, each consisting of 20 items. the first part is the state anxiety scale part. Grouped as (1) None, (2) A little, (3) Much, and (4) All. There are ten reversed statements in the state anxiety scale. These are Articles 1, 2,5, 8, 10, 11, 15, 16, 19 and 20. Trait Anxiety Scale is the second part of the scale. Grouped as (1) Almost never, (2) Sometimes, (3) A lot of time, and (4) Almost always. Reversed on the trait anxiety scale there are expressions. These statements are 21, 26, 27, 30, 33, 36 and 39. The scores obtained from each scale range from 20 to 80. The higher the scores obtained from the scale, the higher the anxiety level.
Urinary infection in the child.
Time frame: Change from Urinary infection in the child at 2 months
Urine analysis will be performed to evaluate the development of urinary tract infection in children undergoing CIC.The diagnosis of urinary tract infection in children will be made in accordance with the literature with the presence of 100,000 colony bacteria in the urine.
Roy adaptatıon model question form
Time frame: Change from at 2 months
Question form created by adhering to NANDA-I nursing diagnoses based on the concepts in the Roy Adaptation Model and the stimuli in the model.The data collection tool used is not a scale. Created by researchers in line with the literature
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Results publication: PubMed 20156062Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available.
- Results publication: PubMed 950697Lapides J, Diokno AC, Gould FR, Lowe BS. Further observations on self-catheterization. J Urol. 1976 Aug;116(2):169-71. doi: 10.1016/s0022-5347(17)58730-3.
- Results publication: PubMed 21430869Singh R, Rohilla RK, Sangwan K, Siwach R, Magu NK, Sangwan SS. Bladder management methods and urological complications in spinal cord injury patients. Indian J Orthop. 2011 Mar;45(2):141-7. doi: 10.4103/0019-5413.77134.
- Results publication: PubMed 16753432Neveus T, von Gontard A, Hoebeke P, Hjalmas K, Bauer S, Bower W, Jorgensen TM, Rittig S, Walle JV, Yeung CK, Djurhuus JC. The standardization of terminology of lower urinary tract function in children and adolescents: report from the Standardisation Committee of the International Children's Continence Society. J Urol. 2006 Jul;176(1):314-24. doi: 10.1016/S0022-5347(06)00305-3.
- Derived from this study: PubMed 39601932Sari C, Demirbag BC. The effect of model-based android phone application supported clean intermittent catheterization training on caregivers and children: A randomized controlled study. Eur J Pediatr. 2024 Nov 27;184(1):46. doi: 10.1007/s00431-024-05890-z.
- Individual participant dataSharing planned: No. I do not want to share my individual participant data with other participants, as I have not completed my work yet.
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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.
CANAN SARI, PhD student principal investigator
Karadeniz Technical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group: Training of caregivers in people with Intermittent Urethral Catheterization and Spinal Dysraphism, run by Karadeniz Technical University at 2 sites 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
knowledge / skill level of caregivers. (time frame: Change from knowledge / skill level of caregivers at 3 months). The study lists 5 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 NCT04763382, 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 21 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.