Pressure Injury PreventionNCT06369844
Pressure Injury Education Intervention for Pediatric Intensive Care Nurses: A Randomized Controlled Trial
A study testing Pressure injury education in people with Pressure Injury Prevention, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this observational study is to find out the impact of pressure injury education on the knowledge level of pediatric intensive care nurses and the likelihood of pediatric pressure injury occurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury Prevention
- What is being tested?
- Pressure injury education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 22 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Working in pediatric intensive care for more than 6 months
- Having provided pressure injury care at least once
- Voluntarily agreeing to participate in the study
- Working in intensive care where pressure injuries are commonly seen.
Who cannot join
- Having wound care certification
- Not attending all of the training sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of 'Stop Pressure Injury' Education for Pediatric Patients on Nurses' Knowledge Level and the Probability of Pediatric Pressure Injury Occurrence
The purpose of this observational study is to find out the impact of pressure injury education on the knowledge level of pediatric intensive care nurses and the likelihood of pediatric pressure injury occurrence. The main questions it aims to answer are:
- Does pressure injury education increase nurses knowledge level on pediatric pressure injuries?
- Does the rate of pediatric pressure injuries decrease after the education?
Read more
The researcher will compare nurses working in two separate pediatric intensive care units where similar patients are treated to see if planned education on pressure injuries affects nurses knowledge level and the rate of pediatric pressure injuries.
- Volunteer nurses participating in the study will answer pressure injury survey questions prepared by the researcher.
- Nurses in the intervention group will attend planned education sessions provided by the researcher.
- Two weeks after the completion of the education sessions, all nurses in the intervention and control groups who wish to continue participating in the study will answer the pressure injury survey questions prepared by the researcher again.
Read the detailed description
Children with critical illness in intensive care units are a high-risk group for pressure injuries due to immobility and intensive medical device use (Setchell et al., 2023). The study will be conducted with nurses working in third-level pediatric intensive care units within a city hospital in Ankara. There are five pediatric intensive care units in the hospital: a 16-bed Pediatric Surgical Intensive Care Unit, a 16-bed Pediatric Cardiovascular Surgery Intensive Care Unit, a 12-bed Pediatric Intensive Care Unit, and another 12-bed Pediatric Intensive Care Unit. The number of nurses working in these intensive care units is 25, 20, 28, and 29, respectively. These 102 nurses constitute the population of the study. Firstly, the sample size was determined. G-power 3.1.9.4 analysis program was used to determine the sample size. Considering a similar study on the topic, the sample size was calculated (Karimian et al., 2020). The effect size was calculated as 1.23 in the reference study. According to this effect size, considering a 5% error rate (α) and 95% power (1-β), it was determined that there should be a total of 38 participants in the study, with 19 in the intervention group and 19 in the control group. However, assuming possible losses in the sample, the sample size was increased by 30%, resulting in 25 participants in the intervention group and 25 in the control group (n1: 25 - n2: 25). Then, considering the sample size, the pediatric intensive care units where nurses would participate in the sampling were determined. Three-month pressure injury rates of these intensive care units were obtained from the hospital's quality unit to determine these units. According to these rates, these intensive care units were ranked. The first two ranks were taken by the Pediatric Intensive Care Units. To prevent the intervention and control groups from influencing each other, one of the intensive care units was designated as the intervention group and the other as the control group. During the assignment, these intensive care units were given names A and B by a person unrelated to the study. The intervention and control groups were determined by a lottery method. There are enough nurses in the relevant intensive care units to meet the determined sample size of the study. After determining the sample size of the study, the training dates were planned. The principal investigator of the study is also the pediatric wound care nurse at the hospital. As of the planned training date, service supervisors and the researcher made two calls for pre-test participation in both the intervention and control groups. Each of the intensive care units involved in the study has 12 beds and provides care to two patients per nurse. There are 8 nurses working in shifts of 08-08 hours per day. Pre-test data collection is planned for 3 days without disrupting the operation of the intensive care units. After the pre-test data collection, a pressure injury training consisting of 3 sessions lasting 40 minutes each will be provided to the intervention group for 1 week without disrupting patient care. Although the intensive care units are on separate floors in the hospital, the nurses are separate, but the patient profiles are similar. Two weeks after the completion of the training, post-test data will be collected in a similar manner. The training will cover pressure injury definition and classification, risk factors and assessment scales for pressure injuries in children, and pressure injury prevention and care. The collected data will be analyzed and interpreted using statistical methods. Pressure injury rates in the intensive care units will be compared again after the training. The questionnaire used to measure the nurses' knowledge levels and the training were created by the principal investigator. The created training and questionnaire were sent to 10 expert doctors who are specialists in their respective fields for expert opinion. The results of the expert opinions were statistically analyzed. The Cronbach's Alpha Internal Consistency Coefficient for the questionnaire used for pre-test and post-test was calculated as a total of 0.977, which is considered highly reliable.The training content has also been found to be at a very appropriate level.
- Conditions
- Pressure Injury Prevention
- Being tested
- Pressure injury education
- Keywords
- pressure injuries, pediatric, nurses knowledge
- 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 educationOther
Pressure injury education will be provided to participants in the intervention group in three separate sessions covering the topics of Pressure Injury Definition and Classification, Risk Assessment, Prevention, and Care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The group that received pediatric pressure injury education Receives: Other: Pressure injury education |
| Control group | No intervention | The group that did not receive pediatric pressure injury education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stop Pressure Injuries" Education Evaluation Survey
The survey consists of subheadings: Pressure Injury Definition and Classification, Risk Assessment, Prevention, and Care. The survey comprises a total of 50 true/false statements. Participants will mark the statements as true or false. They will receive 1 point for correct answers and 0 points for incorrect answers. The total score of the survey is 50.
Measured: he questionnaires prepared by the researcher will be answered by both groups immediately before the training for pre-test results and two weeks after the training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Apr 2024
- Primary completion1 May 2024
- Study completion22 May 2024
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 Pressure Injury PreventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design will be two-group and pretest-posttest design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Neşe ÖZYURT, Ankara Yildirim Beyazıt University
- Investigators
- Neşe Özyurt, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369844
- Sponsor's protocol ID
- 1.2023-440
- Status last verified
- Jul 2024
- First submitted
- 9 Apr 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NAME, SURNAME , EMAIL ADDRESS
Publications
undefined
Triantafyllou C, Chorianopoulou E, Kourkouni E, Zaoutis TE, Kourlaba G. Prevalence, incidence, length of stay and cost of healthcare-acquired pressure ulcers in pediatric populations: A systematic review and meta-analysis. Int J Nurs Stud. 2021 Mar;115:103843. doi: 10.1016/j.ijnurstu.2020.103843. Epub 2020 Dec 16.
PubMed 33373805Lyren A, Brilli R, Bird M, Lashutka N, Muething S. Ohio Children's Hospitals' Solutions for Patient Safety: A Framework for Pediatric Patient Safety Improvement. J Healthc Qual. 2016 Jul-Aug;38(4):213-22. doi: 10.1111/jhq.12058.
PubMed 26042749Li Z, Lin F, Thalib L, Chaboyer W. Global prevalence and incidence of pressure injuries in hospitalised adult patients: A systematic review and meta-analysis. Int J Nurs Stud. 2020 May;105:103546. doi: 10.1016/j.ijnurstu.2020.103546. Epub 2020 Jan 31.
PubMed 321131421. European Pressure Ulcer Asvisory Panel, National Pressure Injury Panel, Pan Pacific Injury Alliance . (2019). Prevention and Treatment of Pressure Ulcers/İnjuries: Clinical Practice Guideline. The İnternational Guideline.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of 'Stop Pressure Injury' Education for Pediatric Patients on Nurses' Knowledge Level and the Probability of Pediatric Pressure Injury Occurrence
- ClinicalTrials.gov ID
- NCT06369844
- Acronym / sponsor ID
- 1.2023-440
- Conditions
- Pressure Injury Prevention
- Keywords
- pressure injuries, pediatric, nurses knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 17 Apr 2024 (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 purpose of this observational study is to find out the impact of pressure injury education on the knowledge level of pediatric intensive care nurses and the likelihood of pediatric pressure injury occurrence. The main questions it aims to answer are:
- Does pressure injury education increase nurses knowledge level on pediatric pressure injuries?
- Does the rate of pediatric pressure injuries decrease after the education?
The researcher will compare nurses working in two separate pediatric intensive care units where similar patients are treated to see if planned education on pressure injuries affects nurses knowledge level and the rate of pediatric pressure injuries.
- Volunteer nurses participating in the study will answer pressure injury survey questions prepared by the researcher.
- Nurses in the intervention group will attend planned education sessions provided by the researcher.
- Two weeks after the completion of the education sessions, all nurses in the intervention and control groups who wish to continue participating in the study will answer the pressure injury survey questions prepared by the researcher again.
Detailed description
Children with critical illness in intensive care units are a high-risk group for pressure injuries due to immobility and intensive medical device use (Setchell et al., 2023). The study will be conducted with nurses working in third-level pediatric intensive care units within a city hospital in Ankara. There are five pediatric intensive care units in the hospital: a 16-bed Pediatric Surgical Intensive Care Unit, a 16-bed Pediatric Cardiovascular Surgery Intensive Care Unit, a 12-bed Pediatric Intensive Care Unit, and another 12-bed Pediatric Intensive Care Unit. The number of nurses working in these intensive care units is 25, 20, 28, and 29, respectively. These 102 nurses constitute the population of the study. Firstly, the sample size was determined. G-power 3.1.9.4 analysis program was used to determine the sample size. Considering a similar study on the topic, the sample size was calculated (Karimian et al., 2020). The effect size was calculated as 1.23 in the reference study. According to this effect size, considering a 5% error rate (α) and 95% power (1-β), it was determined that there should be a total of 38 participants in the study, with 19 in the intervention group and 19 in the control group. However, assuming possible losses in the sample, the sample size was increased by 30%, resulting in 25 participants in the intervention group and 25 in the control group (n1: 25 - n2: 25). Then, considering the sample size, the pediatric intensive care units where nurses would participate in the sampling were determined. Three-month pressure injury rates of these intensive care units were obtained from the hospital's quality unit to determine these units. According to these rates, these intensive care units were ranked. The first two ranks were taken by the Pediatric Intensive Care Units. To prevent the intervention and control groups from influencing each other, one of the intensive care units was designated as the intervention group and the other as the control group. During the assignment, these intensive care units were given names A and B by a person unrelated to the study. The intervention and control groups were determined by a lottery method. There are enough nurses in the relevant intensive care units to meet the determined sample size of the study. After determining the sample size of the study, the training dates were planned. The principal investigator of the study is also the pediatric wound care nurse at the hospital. As of the planned training date, service supervisors and the researcher made two calls for pre-test participation in both the intervention and control groups. Each of the intensive care units involved in the study has 12 beds and provides care to two patients per nurse. There are 8 nurses working in shifts of 08-08 hours per day. Pre-test data collection is planned for 3 days without disrupting the operation of the intensive care units. After the pre-test data collection, a pressure injury training consisting of 3 sessions lasting 40 minutes each will be provided to the intervention group for 1 week without disrupting patient care. Although the intensive care units are on separate floors in the hospital, the nurses are separate, but the patient profiles are similar. Two weeks after the completion of the training, post-test data will be collected in a similar manner. The training will cover pressure injury definition and classification, risk factors and assessment scales for pressure injuries in children, and pressure injury prevention and care. The collected data will be analyzed and interpreted using statistical methods. Pressure injury rates in the intensive care units will be compared again after the training. The questionnaire used to measure the nurses' knowledge levels and the training were created by the principal investigator. The created training and questionnaire were sent to 10 expert doctors who are specialists in their respective fields for expert opinion. The results of the expert opinions were statistically analyzed. The Cronbach's Alpha Internal Consistency Coefficient for the questionnaire used for pre-test and post-test was calculated as a total of 0.977, which is considered highly reliable.The training content has also been found to be at a very appropriate level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study design will be two-group and pretest-posttest design.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pressure injury educationThe group that received pediatric pressure injury education |
| Control group | No intervention | –The group that did not receive pediatric pressure injury education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Working in pediatric intensive care for more than 6 months
- Having provided pressure injury care at least once
- Voluntarily agreeing to participate in the study
- Working in intensive care where pressure injuries are commonly seen.
Key exclusion criteria (2 listed)
- Having wound care certification
- Not attending all of the training sessions
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 educationPressure injury education will be provided to participants in the intervention group in three separate sessions covering the topics of Pressure Injury Definition and Classification, Risk Assessment, Prevention, and Care. | Other | Intervention group |
Primary outcome
Stop Pressure Injuries" Education Evaluation Survey
Time frame: he questionnaires prepared by the researcher will be answered by both groups immediately before the training for pre-test results and two weeks after the training.
The survey consists of subheadings: Pressure Injury Definition and Classification, Risk Assessment, Prevention, and Care. The survey comprises a total of 50 true/false statements. Participants will mark the statements as true or false. They will receive 1 point for correct answers and 0 points for incorrect answers. The total score of the survey is 50.
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 5 Jul 2024.
- Backgroundundefined
- Background: PubMed 33373805Triantafyllou C, Chorianopoulou E, Kourkouni E, Zaoutis TE, Kourlaba G. Prevalence, incidence, length of stay and cost of healthcare-acquired pressure ulcers in pediatric populations: A systematic review and meta-analysis. Int J Nurs Stud. 2021 Mar;115:103843. doi: 10.1016/j.ijnurstu.2020.103843. Epub 2020 Dec 16.
- Background: PubMed 26042749Lyren A, Brilli R, Bird M, Lashutka N, Muething S. Ohio Children's Hospitals' Solutions for Patient Safety: A Framework for Pediatric Patient Safety Improvement. J Healthc Qual. 2016 Jul-Aug;38(4):213-22. doi: 10.1111/jhq.12058.
- Background: PubMed 32113142Li Z, Lin F, Thalib L, Chaboyer W. Global prevalence and incidence of pressure injuries in hospitalised adult patients: A systematic review and meta-analysis. Int J Nurs Stud. 2020 May;105:103546. doi: 10.1016/j.ijnurstu.2020.103546. Epub 2020 Jan 31.
- Background1. European Pressure Ulcer Asvisory Panel, National Pressure Injury Panel, Pan Pacific Injury Alliance . (2019). Prevention and Treatment of Pressure Ulcers/İnjuries: Clinical Practice Guideline. The İnternational Guideline.
- Individual participant dataSharing planned: Yes. NAME, SURNAME , EMAIL ADDRESS
Related trials for Pressure Injury Prevention
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Enrolling by invitationObservational study
Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
Pressure Injury Prevention
Not yet recruiting
Sacrum Pressure Injury Prevention Study Using ALLEVYN◊ Complete Care in Adults at Risk of Developing Hospital-acquired Pressure Injuries in Critical Care Units
Pressure Ulcers (Hospital-acquired Pressure Injuries)
Not yet recruiting
Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy
Open Abdomen, Incisional Hernia
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.
Neşe Özyurt principal investigator
Principal Investigator
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 education in people with Pressure Injury Prevention, 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 4 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 5 Jul 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?
Stop Pressure Injuries" Education Evaluation Survey (time frame: he questionnaires prepared by the researcher will be answered by both groups immediately before the training for pre-test results and two weeks after the training.). 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 NCT06369844, 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 5 Jul 2024.