Pressure UlcerNCT06509399
Care Package for Preventing Pressure Ulcers in ICU Patients
A study testing care package in people with Pressure Ulcer and Nursing Caries, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effectiveness of the care package (CP) developed to prevent pressure injury (PI) in patients in intensive care and to evaluate the effect of the training given to nurses on their knowledge levels and attitudes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Nursing Caries
- What is being tested?
- care package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 18 years of age or older,
- No development of pressure ulcers in any part of the body,
- Patients expected to stay in the clinic for at least 72 hours or more
- patients with a braden score below 15 points
- Obtaining written consent from the first-degree relatives of patients whose written consent is obtained, patients who are unconscious and unable to give consent
Who cannot join
- - 18 years of age or younger,
- BY in any part of the body,
- BBYRDS score more than 15
- Failure to give written consent by himself/herself or his/her 1st degree relative
- Exitus, discharge, change of department and the patient's wish to leave the study before completing the number of days determined during the data collection phase
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Abant Izzet Baysal University Faculty of Health Science
Bolu, Merkez, 14100
Bolu Abant İzzet Baysal Üniversitesi/Sağlık Bilimleri Fakültesi
Bolu, 14100
About this study
Official title: Evaluation of the Effectiveness of a Pressure Ulcers Prevention Care Package in the Intensive Care Unit
The aim of this study is to evaluate the effectiveness of the care package (CP) developed to prevent pressure injury (PI) in patients in intensive care and to evaluate the effect of the training given to nurses on their knowledge levels and attitudes.
Read the detailed description
This experimental study was carried out in the anesthesia and reanimation intensive care unit of Düzce Atatürk State Hospital. The part with patients was completed with a total of 72 patients, 36 in the control group and 36 in the application group. The occurrence rate of PI was compared between the control group and the application group. In the section about nurses, no sample was selected and all 50 nurses working in intensive care were included in the study. Nurses' knowledge and attitudes about PI before and after the training were compared. Data were analyzed using a statistical program.
- Conditions
- Pressure Ulcer, Nursing Caries
- Being tested
- care package
- Keywords
- Pressure ulcer, Care package, Intensive care unit, Evidence-based practice, Nursing
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care packageOther
Before the patients in the application group started to be observed, the nurses working in the clinic were trained about the risk assessment, skin assessment, incontinence management, nutrition assessment, positioning, support surfaces and injuries caused by the devices in the BP content to be used in the prevention of IU. After the trainings given to the nurses were completed, care was given to the patients in the practice group in accordance with BP. In addition, patient information was collected from patient information files, nurse observation forms and hospital automation system. In the evaluation step, full compliance with the 7 compliance steps specified in the BP was sought. If any one of these parameters was incomplete, the others were considered as incomplete.
The patients in the control group were followed up for 30 days until the determined number of patients was reached and their data were collected.
| Study group | Role | What they receive |
|---|---|---|
| PRESSURE ULCERS PREVENTION CARE PACKAGE IN INTENSİVE CARE UNIT | Experimental | This experimental study was carried out in the anesthesia and reanimation intensive care unit of Düzce Atatürk State Hospital. The part with patients was completed with a total of 72 patients, 36 in the control group and 36 in the application group. The occurrence rate of PI was compared between the control group and the application group. Receives: Other: care package |
| NURSES' LEVEL OF KNOWLEDGE ABOUT THE CARE PACKAGE | No intervention | In the section about nurses, no sample was selected and all 50 nurses working in intensive care were included in the study. Nurses' knowledge and attitudes about PI before and after the training were compared. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Ulcer Formation
Ulcer formation was monitored. Patients were followed up for at least 10 days in this respect.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Knowledge levels of nurses
Knowledge levels of nurses were tested before and after the training with the pressure sore assessment form prepared by the researchers.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start15 May 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- experimental study randomised controlled
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ganime Esra Soysal, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509399
- Sponsor's protocol ID
- SBF-HMS-GES-04
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 19 Jul 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 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Pressure Ulcers Prevention Care Package in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06509399
- Acronym / sponsor ID
- SBF-HMS-GES-04
- Conditions
- Pressure Ulcer, Nursing Caries
- Keywords
- Pressure ulcer, Care package, Intensive care unit, Evidence-based practice, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 19 Jul 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 aim of this study is to evaluate the effectiveness of the care package (CP) developed to prevent pressure injury (PI) in patients in intensive care and to evaluate the effect of the training given to nurses on their knowledge levels and attitudes.
Detailed description
This experimental study was carried out in the anesthesia and reanimation intensive care unit of Düzce Atatürk State Hospital. The part with patients was completed with a total of 72 patients, 36 in the control group and 36 in the application group. The occurrence rate of PI was compared between the control group and the application group. In the section about nurses, no sample was selected and all 50 nurses working in intensive care were included in the study. Nurses' knowledge and attitudes about PI before and after the training were compared. Data were analyzed using a statistical program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- experimental study randomised controlled
| Arm | Type | Receives |
|---|---|---|
| PRESSURE ULCERS PREVENTION CARE PACKAGE IN INTENSİVE CARE UNIT | Experimental | Other: care packageThis experimental study was carried out in the anesthesia and reanimation intensive care unit of Düzce Atatürk State Hospital. The part with patients was completed with a total of 72 patients, 36 in the control group and 36 in the application group. The occurrence rate of PI was compared between the control group and the application group. |
| NURSES' LEVEL OF KNOWLEDGE ABOUT THE CARE PACKAGE | No intervention | –In the section about nurses, no sample was selected and all 50 nurses working in intensive care were included in the study. Nurses' knowledge and attitudes about PI before and after the training were compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - 18 years of age or older,
- No development of pressure ulcers in any part of the body,
- Patients expected to stay in the clinic for at least 72 hours or more
- patients with a braden score below 15 points
- Obtaining written consent from the first-degree relatives of patients whose written consent is obtained, patients who are unconscious and unable to give consent
Key exclusion criteria (5 listed)
- - 18 years of age or younger,
- BY in any part of the body,
- BBYRDS score more than 15
- Failure to give written consent by himself/herself or his/her 1st degree relative
- Exitus, discharge, change of department and the patient's wish to leave the study before completing the number of days determined during the data collection phase
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 |
|---|---|---|
| care packageBefore the patients in the application group started to be observed, the nurses working in the clinic were trained about the risk assessment, skin assessment, incontinence management, nutrition assessment, positioning, support surfaces and injuries caused by the devices in the BP content to be used in the prevention of IU. After the trainings given to the nurses were completed, care was given to the patients in the practice group in accordance with BP. In addition, patient information was collected from patient information files, nurse observation forms and hospital automation system. In the evaluation step, full compliance with the 7 compliance steps specified in the BP was sought. If any one of these parameters was incomplete, the others were considered as incomplete. The patients in the control group were followed up for 30 days until the determined number of patients was reached and their data were collected. | Other | PRESSURE ULCERS PREVENTION CARE PACKAGE IN INTENSİVE CARE UNIT |
Primary outcome
Pressure Ulcer Formation
Time frame: through study completion, an average of 1 year
Ulcer formation was monitored. Patients were followed up for at least 10 days in this respect.
1 secondary outcome
Knowledge levels of nurses
Time frame: through study completion, an average of 1 year
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 19 Jul 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care package in people with Pressure Ulcer and Nursing Caries, run by Abant Izzet Baysal 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 5 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: finished, as of the sponsor's last update on 19 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 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?
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?
Pressure Ulcer Formation (time frame: through study completion, an average of 1 year). 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 19 Jul 2024.