Pressure InjuryNCT05762341
Pressure Injury Training With a Blended Approach Learning Approach on Care Behaviors of Intensive Care Nurses
A study testing PRESSURE INJURY PREVENTION TRAINING in people with Pressure Injury, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
By saving life or delaying death, the length of stay of the patient in the intensive care unit is prolonged, and this leads to the emergence of other problems in addition to the disease in the patient. Pressure injuries are one of these problems. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury
- What is being tested?
- PRESSURE INJURY PREVENTION TRAINING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 15 Mar 2023
- 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
- Adult intensive care nurses working in the Third Level intensive care unit,
- have not received pressure injury training in the last year,
- voluntarily agree to participate in the study will be included.
Who cannot join
- Nurses who received pressure injury training in the last year
- work in the pediatric intensive care unit and neonatal intensive care unit
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul university Cerrahpaşa hospital
Istanbul
About this study
Official title: Istanbul University Cerrahpaşa Graduate Education Institute, PhD Student
By saving life or delaying death, the length of stay of the patient in the intensive care unit is prolonged, and this leads to the emergence of other problems in addition to the disease in the patient. Pressure injuries are one of these problems. Although many internationally accepted pressure injury prevention guidelines are available, it is frequently reported that there is no significant reduction in pressure injury prevalence. It has been emphasized in the literature that nurses do not have enough knowledge about the prevention of pressure injury. "Blended Learning", in which technologies such as web-based, e-learning and m-learning are used together with face-to-face education, is an effective approach in realizing learning outcomes. This approach facilitates the achievement of the educational program's objectives by integrating the positive aspects of web-assisted learning and face-to-face learning. In the light of these explanations, it is aimed to examine the effect of pressure injury prevention training given with the blended learning approach on the care behaviors of intensive care nurses.
Read the detailed description
The research was planned in a mixed design with a qualitative dimension in terms of determining the experimental and training needs, using the focus group interview method in the evaluation of the program, with the aim of examining the effect of pressure injury prevention training given with the blended learning approach on the care behaviors of intensive care nurses.The universe of the study consists of a total of 100 nurses working in the 3rd Level intensive care units of Istanbul University-Cerrahpaşa Cerrahpaşa Faculty of Medicine. The sample size of the study was calculated by using power analysis. Since the differences between the experimental and control groups before and after the experiment were examined comparatively in the research, ANOVA will be made for mixed measurements. Accordingly, the sample size was calculated by keeping the effect size (Cohen's f) 0.25, that is, at a medium level, based on the expected averages and standard deviations of the groups. G*Power 3.1.9.4 software (Faul, Erdfelder, Lang \& Buchner, 2007) was used for the calculation. In order to make a decision with 95% confidence for Type I, the expected power of α error was 0.05 and for Type II error 1-β expected power was 0.80. When the number of groups was entered as 2 (experiment, control), the number of measurements was 2 (pretest, posttest), the expected correlation between repeated measurements was 0.5, and the ε correction was 1, the expected total sample size for this study was calculated as 34 people. Accordingly, there will be a total of 44 people in the research, 17 people in the experimental and control groups, taking into account the possibility of data loss. In order to prevent interaction between the groups in the formation of the experimental and control groups, it will be randomly assigned by paying attention to the fact that the experimental group is from one unit and the control group is from the other unit. Homogenization will be achieved between the groups in terms of having an intensive care nursing certificate, age, years of experience, years of working in intensive care, and Knowledge Evaluation Scale score in Preventing Pressure Ulcers. It will be collected by the researcher and the nurse in charge of the unit by using the Nurse Information Form, the Information Evaluation Scale in Pressure Ulcer Prevention, the Pressure Injury Prevention Efficiency Evaluation Form, the Training Program Evaluation Form, the Semi-Structured Interview Form before the Training Program, and the Semi-Structured Interview Form after the Training Program.
- Conditions
- Pressure Injury
- Being tested
- PRESSURE INJURY PREVENTION TRAINING
- Keywords
- "pressure injury", "intensive care nurse" , "prevention"
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRESSURE INJURY PREVENTION TRAININGOther
PREVENTION OF PRESSURE INJURY TO FACE TO FACE TRAINING
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENT GROUP | Experimental | BOTH GROUPS WILL RECEIVE PRESSURE INJURY PREVENTION TRAINING. ONLY EXPERIMENTAL GROUP WILL USE THE MOBILE LEARNING TOOL Receives: Other: PRESSURE INJURY PREVENTION TRAINING |
| CONTROL GROUP | Experimental | BOTH GROUPS WILL RECEIVE PRESSURE INJURY PREVENTION TRAINING. ONLY EXPERIMENTAL GROUP WILL USE THE MOBILE LEARNING TOOL Receives: Other: PRESSURE INJURY PREVENTION TRAINING |
What is being measured
The primary outcome is the main question the study is designed to answer.
INCREASE IN PRESSURE INJURY PREVENTION BEHAVIOR SCORES
INCREASED BEHAVIOR SCORES TO BE TAKEN FROM THE PRESSURE INJURY PREVENTION QUALIFICATION FORM
Measured: 3 MONTHS LATER
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Mar 2023
- Primary completion14 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Number of groups 2 (experiment, control), number of measurements 2 (pretest, posttest),
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Kiraner, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762341
- Sponsor's protocol ID
- IUC Gradu Educ Inst
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Istanbul University Cerrahpaşa Graduate Education Institute, PhD Student
- ClinicalTrials.gov ID
- NCT05762341
- Acronym / sponsor ID
- IUC Gradu Educ Inst
- Conditions
- Pressure Injury
- Keywords
- "pressure injury", "intensive care nurse" , "prevention"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 9 Mar 2023 (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.
By saving life or delaying death, the length of stay of the patient in the intensive care unit is prolonged, and this leads to the emergence of other problems in addition to the disease in the patient. Pressure injuries are one of these problems. Although many internationally accepted pressure injury prevention guidelines are available, it is frequently reported that there is no significant reduction in pressure injury prevalence. It has been emphasized in the literature that nurses do not have enough knowledge about the prevention of pressure injury. "Blended Learning", in which technologies such as web-based, e-learning and m-learning are used together with face-to-face education, is an effective approach in realizing learning outcomes. This approach facilitates the achievement of the educational program's objectives by integrating the positive aspects of web-assisted learning and face-to-face learning. In the light of these explanations, it is aimed to examine the effect of pressure injury prevention training given with the blended learning approach on the care behaviors of intensive care nurses.
Detailed description
The research was planned in a mixed design with a qualitative dimension in terms of determining the experimental and training needs, using the focus group interview method in the evaluation of the program, with the aim of examining the effect of pressure injury prevention training given with the blended learning approach on the care behaviors of intensive care nurses.The universe of the study consists of a total of 100 nurses working in the 3rd Level intensive care units of Istanbul University-Cerrahpaşa Cerrahpaşa Faculty of Medicine. The sample size of the study was calculated by using power analysis. Since the differences between the experimental and control groups before and after the experiment were examined comparatively in the research, ANOVA will be made for mixed measurements. Accordingly, the sample size was calculated by keeping the effect size (Cohen's f) 0.25, that is, at a medium level, based on the expected averages and standard deviations of the groups. G*Power 3.1.9.4 software (Faul, Erdfelder, Lang \& Buchner, 2007) was used for the calculation. In order to make a decision with 95% confidence for Type I, the expected power of α error was 0.05 and for Type II error 1-β expected power was 0.80. When the number of groups was entered as 2 (experiment, control), the number of measurements was 2 (pretest, posttest), the expected correlation between repeated measurements was 0.5, and the ε correction was 1, the expected total sample size for this study was calculated as 34 people. Accordingly, there will be a total of 44 people in the research, 17 people in the experimental and control groups, taking into account the possibility of data loss. In order to prevent interaction between the groups in the formation of the experimental and control groups, it will be randomly assigned by paying attention to the fact that the experimental group is from one unit and the control group is from the other unit. Homogenization will be achieved between the groups in terms of having an intensive care nursing certificate, age, years of experience, years of working in intensive care, and Knowledge Evaluation Scale score in Preventing Pressure Ulcers. It will be collected by the researcher and the nurse in charge of the unit by using the Nurse Information Form, the Information Evaluation Scale in Pressure Ulcer Prevention, the Pressure Injury Prevention Efficiency Evaluation Form, the Training Program Evaluation Form, the Semi-Structured Interview Form before the Training Program, and the Semi-Structured Interview Form after the Training Program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Number of groups 2 (experiment, control), number of measurements 2 (pretest, posttest),
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENT GROUP | Experimental | Other: PRESSURE INJURY PREVENTION TRAININGBOTH GROUPS WILL RECEIVE PRESSURE INJURY PREVENTION TRAINING. ONLY EXPERIMENTAL GROUP WILL USE THE MOBILE LEARNING TOOL |
| CONTROL GROUP | Experimental | Other: PRESSURE INJURY PREVENTION TRAININGBOTH GROUPS WILL RECEIVE PRESSURE INJURY PREVENTION TRAINING. ONLY EXPERIMENTAL GROUP WILL USE THE MOBILE LEARNING TOOL |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult intensive care nurses working in the Third Level intensive care unit,
- have not received pressure injury training in the last year,
- voluntarily agree to participate in the study will be included.
Key exclusion criteria (2 listed)
- Nurses who received pressure injury training in the last year
- work in the pediatric intensive care unit and neonatal intensive care unit
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 |
|---|---|---|
| PRESSURE INJURY PREVENTION TRAININGPREVENTION OF PRESSURE INJURY TO FACE TO FACE TRAINING | Other | CONTROL GROUP, EXPERIMENT GROUP |
Primary outcome
INCREASE IN PRESSURE INJURY PREVENTION BEHAVIOR SCORES
Time frame: 3 MONTHS LATER
INCREASED BEHAVIOR SCORES TO BE TAKEN FROM THE PRESSURE INJURY PREVENTION QUALIFICATION FORM
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 31 Mar 2023.
- 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 PRESSURE INJURY PREVENTION TRAINING in people with Pressure Injury, run by Istanbul University - Cerrahpasa 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 3 inclusion and 2 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 31 Mar 2023. 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?
INCREASE IN PRESSURE INJURY PREVENTION BEHAVIOR SCORES (time frame: 3 MONTHS LATER). 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 31 Mar 2023.