Stoma IleostomyNCT04984161
The Effect of Stoma Care Education on the Knowledge and Skill Levels of Pediatric Surgery Nurses
A study testing education in people with Stoma Ileostomy and Stoma Colostomy, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This project; It is a quasi-experimental prospective study in a single group pre-test post-test order. No randomization will be made in the selection of the sample, and 30 nurses working in the Pediatric Surgery Clinic in hospitals in Izmir and meeting the inclusion criteria will be included in the study. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stoma Ileostomy, Stoma Colostomy, Nurse's Role
- What is being tested?
- education
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 29 Feb 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Working in the Pediatric Surgery Clinic
- Volunteering to participate in the study
Who cannot join
- -Having received any previous training on stoma care
Trial locations and contacts
1 site in 1 country.
About this study
This project; It is a quasi-experimental prospective study in a single group pre-test post-test order. No randomization will be made in the selection of the sample, and 30 nurses working in the Pediatric Surgery Clinic in hospitals in Izmir and meeting the inclusion criteria will be included in the study. The data of the study will be collected through the Nurse Descriptive Characteristics Questionnaire and the Pediatric Stoma Care Knowledge and Skills Questionnaire. Pre-training introductory characteristics and pediatric stoma care knowledge and skill level of all nurses participating in the study will be measured. After the measurement, the nurses participating in the study will be given training on pediatric stoma care. Immediately after the training and three months later, the pediatric stoma care knowledge and skill levels of the nurses participating in the study will be re-measured. The introductory characteristics of the nurses involved in the project will be given as number and percentage distributions. Comparisons between nurses' introductory characteristics and Stoma Knowledge and Skills Questionnaire before and after education; It will be evaluated by non-parametric or parametric appropriate test. Comparisons between nurses' Stoma Knowledge and Skills Questionnaire scores in the pre- and post-education period will be evaluated by non-parametric or parametric appropriate test in dependent groups. The statistical significance value of the project was determined as p≤0.005. It is planned that the results of the project will mediate an international article and statement in which the effect of stoma care education on the knowledge and skill level of pediatric surgery nurses is presented. As a result of the project, if it is determined that stoma care education has an effect on the knowledge and skill level of pediatric surgery nurses, it is predicted that the quality of care of children with stoma who receive care in other institutions and organizations can be increased and the comfort of the child can be increased.
- Conditions
- Stoma Ileostomy, Stoma Colostomy, Nurse's Role, Pediatric Surgery
- Being tested
- education
- Keywords
- stoma care, pediatric surgery, nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
The aim of this project is to examine the effect of stoma care education on the knowledge and skill levels of pediatric surgery nurses about stoma care.
What is being measured
The primary outcome is the main question the study is designed to answer.
nurse's pediatric stoma care skills level
Immediately after pediatric stoma care education, the pediatric stoma care knowledge level of the participating nurses will be measured with the Pediatric Stoma Care Knowledge and Skills questionnaire.
Measured: immediately after pediatric stoma care education
nurse's pediatric stoma care knowledge level
Immediately after pediatric stoma care education, the pediatric stoma care knowledge level of the participating nurses will be measured with the Pediatric Stoma Care Knowledge and Skills questionnaire.
Measured: immediately after pediatric stoma care education
nurse's pediatric stoma care skills level
3 months after pediatric stoma care education, the pediatric stoma care knowledge level of the participating nurses will be measured with the Pediatric Stoma Care Knowledge and Skills questionnaire.
Measured: 3 months after pediatric stoma care education
nurse's pediatric stoma care knowledge level
3 months after pediatric stoma care education, the pediatric stoma care knowledge level of the participating nurses will be measured with the Pediatric Stoma Care Knowledge and Skills questionnaire.
Measured: 3 months after pediatric stoma care education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Nov 2022
- Primary completion1 Jan 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma IleostomyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA ARDAHAN AKGUL, Izmir Katip Celebi University
- Investigators
- Esra ARDAHAN AKGÜL, Study chair, İzmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984161
- Sponsor's protocol ID
- TUBITAK 2209
- Status last verified
- Oct 2024
- First submitted
- 25 Jul 2021
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stoma Care Education on the Knowledge and Skill Levels of Pediatric Surgery Nurses
- ClinicalTrials.gov ID
- NCT04984161
- Acronym / sponsor ID
- TUBITAK 2209
- Conditions
- Stoma Ileostomy, Stoma Colostomy, Nurse's Role, Pediatric Surgery
- Keywords
- stoma care, pediatric surgery, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 30 Jul 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.
This project; It is a quasi-experimental prospective study in a single group pre-test post-test order. No randomization will be made in the selection of the sample, and 30 nurses working in the Pediatric Surgery Clinic in hospitals in Izmir and meeting the inclusion criteria will be included in the study. The data of the study will be collected through the Nurse Descriptive Characteristics Questionnaire and the Pediatric Stoma Care Knowledge and Skills Questionnaire. Pre-training introductory characteristics and pediatric stoma care knowledge and skill level of all nurses participating in the study will be measured. After the measurement, the nurses participating in the study will be given training on pediatric stoma care. Immediately after the training and three months later, the pediatric stoma care knowledge and skill levels of the nurses participating in the study will be re-measured. The introductory characteristics of the nurses involved in the project will be given as number and percentage distributions. Comparisons between nurses' introductory characteristics and Stoma Knowledge and Skills Questionnaire before and after education; It will be evaluated by non-parametric or parametric appropriate test. Comparisons between nurses' Stoma Knowledge and Skills Questionnaire scores in the pre- and post-education period will be evaluated by non-parametric or parametric appropriate test in dependent groups. The statistical significance value of the project was determined as p≤0.005. It is planned that the results of the project will mediate an international article and statement in which the effect of stoma care education on the knowledge and skill level of pediatric surgery nurses is presented. As a result of the project, if it is determined that stoma care education has an effect on the knowledge and skill level of pediatric surgery nurses, it is predicted that the quality of care of children with stoma who receive care in other institutions and organizations can be increased and the comfort of the child can be increased.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Working in the Pediatric Surgery Clinic
- Volunteering to participate in the study
Key exclusion criteria (1 listed)
- -Having received any previous training on stoma care
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 |
|---|---|---|
| educationThe aim of this project is to examine the effect of stoma care education on the knowledge and skill levels of pediatric surgery nurses about stoma care. | Other | – |
Primary outcome
nurse's pediatric stoma care skills level
Time frame: immediately after pediatric stoma care education
Immediately after pediatric stoma care education, the pediatric stoma care knowledge level of the participating nurses will be measured with the Pediatric Stoma Care Knowledge and Skills questionnaire.
nurse's pediatric stoma care knowledge level
Time frame: immediately after pediatric stoma care education
Immediately after pediatric stoma care education, the pediatric stoma care knowledge level of the participating nurses will be measured with the Pediatric Stoma Care Knowledge and Skills questionnaire.
nurse's pediatric stoma care skills level
Time frame: 3 months after pediatric stoma care education
3 months after pediatric stoma care education, the pediatric stoma care knowledge level of the participating nurses will be measured with the Pediatric Stoma Care Knowledge and Skills questionnaire.
nurse's pediatric stoma care knowledge level
Time frame: 3 months after pediatric stoma care education
3 months after pediatric stoma care education, the pediatric stoma care knowledge level of the participating nurses will be measured with the Pediatric Stoma Care Knowledge and Skills questionnaire.
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 22 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Stoma Ileostomy
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Active, not recruitingPhase 2
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
Crohn's Disease
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
RecruitingObservational study
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
Colostomy - Stoma, Ileostomy - Stoma
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.
Esra ARDAHAN AKGÜL study chair
İzmir Katip Çelebi University
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 Stoma Ileostomy and Stoma Colostomy, run by Izmir Katip Celebi 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 2 inclusion and 1 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 22 Oct 2024. 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?
nurse's pediatric stoma care skills level (time frame: immediately after pediatric stoma care education). The study lists 4 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 22 Oct 2024.