Nurse's RoleNCT05625672
EFFICIENCY OF HEMOVIGILANCE MODULE TRAININGS GIVEN TO NURSES
A study testing Training in people with Nurse's Role and Training Group, Sensitivity, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is to determine the effectiveness of hemovigilance module training given to nurses. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Training Group, Sensitivity
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2022to 8 Jul 2022
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- She/He voluntarily agrees to participate in the research, Working as a nurse in the clinic and intensive care unit where blood transfusions are the most, Working for at least 6 months,
Who cannot join
- Nurses working in the emergency and operating rooms, in clinics where blood transfusion is not performed the most, Being a new nurse, On maternity leave and maternity leave, Having an external assignment, Nurses working in the polyclinic,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF THE EFFICIENCY OF HEMOVIGILANCE MODULE TRAININGS
The aim of the present study is to determine the effectiveness of hemovigilance module training given to nurses.
Read the detailed description
125 nurses from the clinic and intensive care units, who received the most intensive blood transfusion from two different hospitals, were included in the study as the intervention and control groups. The control group was not trained. Only the pretest was administered one week after the posttest. After the pre-test was applied to the nurses in the intervention group, five modules of training, which lasted four hours, were given using interactive methods. Five modules of training were prepared by the researcher. These five modules are the 1st module of training; definition of hemovigilance, its aims, the development of hemovigilance in the world and in Turkey, and legal legislation, Module 2; Donor selection, Blood donation Process, Phlebotomy and Donor reactions, Module 3; blood, blood transfusion, its purpose, properties of blood and blood components, Blood transfusion process, Module 4; acute and delayed transfusion reactions and management, Module 5; It consists of the national hemovigilance system, the organization of the hemovigilance system at the hospital level, Traceability, Trace-back from the Patient to the Donor, and Look-back from the Donor to the Patient. the training was over, the final test was administered. One month later, this test was repeated.
- Conditions
- Nurse's Role, Training Group, Sensitivity
- Being tested
- Training
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Hemovigilance module training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Five modules of training on hemovigilance were given in 5 hours. A pre-test was applied at the beginning of the training. The final test was done at the end of the training. One month later, the same test was applied again to measure the permanence of the training. Receives: Other: Training |
| Control | No intervention | No training was provided. Only the pretest was administered one week after the posttest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemovigilance Information Form
It consists of fifteen questions about hemovigilance and hemovigilance system and definitions.
Measured: 5 hours or 1 month
Information Form on Blood Transfusion Complications
This section consists of nine questions including transfusion complications.
Measured: 5 hours or 1 month
Information Form on Blood Transfusion Applications
This section consists of sixteen questions including donor selection, questions about blood components, blood group and safe blood transfusion.
Measured: 5 hours or 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start25 Apr 2022
- Primary completion26 May 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group, placebo-controlled study
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625672
- Sponsor's protocol ID
- 2022-38
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 23 Nov 2022
- 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 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFICIENCY OF HEMOVIGILANCE MODULE TRAININGS
- ClinicalTrials.gov ID
- NCT05625672
- Acronym / sponsor ID
- 2022-38
- Conditions
- Nurse's Role, Training Group, Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 23 Nov 2022 (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.
The aim of the present study is to determine the effectiveness of hemovigilance module training given to nurses.
Detailed description
125 nurses from the clinic and intensive care units, who received the most intensive blood transfusion from two different hospitals, were included in the study as the intervention and control groups. The control group was not trained. Only the pretest was administered one week after the posttest. After the pre-test was applied to the nurses in the intervention group, five modules of training, which lasted four hours, were given using interactive methods. Five modules of training were prepared by the researcher. These five modules are the 1st module of training; definition of hemovigilance, its aims, the development of hemovigilance in the world and in Turkey, and legal legislation, Module 2; Donor selection, Blood donation Process, Phlebotomy and Donor reactions, Module 3; blood, blood transfusion, its purpose, properties of blood and blood components, Blood transfusion process, Module 4; acute and delayed transfusion reactions and management, Module 5; It consists of the national hemovigilance system, the organization of the hemovigilance system at the hospital level, Traceability, Trace-back from the Patient to the Donor, and Look-back from the Donor to the Patient. the training was over, the final test was administered. One month later, this test was repeated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel-group, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: TrainingFive modules of training on hemovigilance were given in 5 hours. A pre-test was applied at the beginning of the training. The final test was done at the end of the training. One month later, the same test was applied again to measure the permanence of the training. |
| Control | No intervention | –No training was provided. Only the pretest was administered one week after the posttest. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- She/He voluntarily agrees to participate in the research, Working as a nurse in the clinic and intensive care unit where blood transfusions are the most, Working for at least 6 months,
Key exclusion criteria (1 listed)
- Nurses working in the emergency and operating rooms, in clinics where blood transfusion is not performed the most, Being a new nurse, On maternity leave and maternity leave, Having an external assignment, Nurses working in the polyclinic,
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 |
|---|---|---|
| TrainingHemovigilance module training | Other | Intervention |
Primary outcome
Hemovigilance Information Form
Time frame: 5 hours or 1 month
It consists of fifteen questions about hemovigilance and hemovigilance system and definitions.
Information Form on Blood Transfusion Complications
Time frame: 5 hours or 1 month
This section consists of nine questions including transfusion complications.
Information Form on Blood Transfusion Applications
Time frame: 5 hours or 1 month
This section consists of sixteen questions including donor selection, questions about blood components, blood group and safe blood transfusion.
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 23 Nov 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Nurse's Role and Training Group, Sensitivity, run by Ankara Yildirim Beyazıt 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 1 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 23 Nov 2022. 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?
Hemovigilance Information Form (time frame: 5 hours or 1 month). The study lists 3 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 23 Nov 2022.