- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05541198
Prevention to Pressure Injury With Care Bundle
Evaluation of Pressure Injury Prevention Care Bundle Application in Intensive Care Unit Patients Diagnosed With Internal Diseases
Aim: The study was conducted in order to evaluate of pressure injury prevention care bundle application in intensive care unit patients diagnosed with internal diseases.
Background: Although a pressure injury is a problem that requires treatment for a long time and takes time to heal, it is possible to prevent it with appropriate interventions. Evidence for the prevention of pressure injuries suggests using evidence-based guidelines or care bundles.
Design: Quasi-experimental and control group study. Methods: The study was conducted on 98 patients, 49 in the control group and 49 in the intervention group, diagnosed with internal diseases and hospitalized in the intensive care unit of a training and research hospital between July-December 2021. In the collection of the study data, patient information form, pressure injury prevention care bundle tool, and Braden Risk Scale were used. While routine clinical care continued to be provided to the patients in the control group, pressure injury prevention care bundle was applied to the patients in the intervention group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As preventing the development of pressure injury is a parameter that shows the quality of care, the most significant responsibility in preventing pressure injury belongs to nurses. Pressure injury develops as a result of inadequate nursing care and not routinely applying evidence-based planned care in preventing pressure injury. In this sense, nurses can prevent the development of pressure injury by evaluating the patient holistically and applying evidence-based preventive pressure injury care.
Although a pressure injury is a problem that requires treatment for a long time and takes time to heal, it is possible to prevent it with appropriate interventions.In this context, European Pressure Injury Advisory Panel (EPIAP) and National Pressure Injury Advisory Panel (NPIAP) determined several preventive stages in order to prevent pressure injuries, such as risk assessment, skin assessment and care, repositioning, using pressure reducing surfaces, protection from incontinence, nutrition and fluid support, and training .
Evidence for the prevention of pressure injuries suggests using evidence-based guidelines or care bundles. Care bundle is an organized and medical regulations-based set of applications that promotes compliance with guidelines and increases the quality of care by facilitating the provision of evidence-based care.
In the present study, it was aimed to prevent the development of pressure injuries by applying the prepared pressure injury prevention bundle care to the patients hospitalized in the intensive care unit patients diagnosed with internal diseases and thus to determine the effectiveness of the care bundle.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Uskudar, Turkey
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Istanbul, Istanbul, Uskudar, Turkey, Turkey, 34668
- Gülnaz Altaş
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years old and above,
- Who did not have any pressure injuries on any part of their body,
- Who were expected to stay in the clinic for at least 24 hours,
- Who were diagnosed with an internal disease
Exclusion Criteria:
- Who were younger than 18 years,
- Who had a pressure injury on any part of their body,
- Who were expected to stay in the clinic for less than 24 hours
- Who had intensive care indications other than an internal disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Routine clinical care continued to be provided to the patients in the control group. Routine maintenance applications include the following parameters;
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Experimental: Intervention Group
A pressure injury care bundle was developed in line with the relevant literature. After the development of the bundle, a 30-minute training program was applied to the nurses on general information about pressure injuries, the pressure injury care bundle, and how to use the bundle. The training program was carried out in four separate sessions arranged according to the working schedules of 40 nurses providing services in ICU. Care Bundle include this parameters;
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Information Form
Time Frame: 60 minutes
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The form prepared by the researcher includes questions inquiring about the sociodemographic and background information of the patients, clinical characteristics and laboratory results.
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60 minutes
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Pressure Injury Prevention Care Bundle
Time Frame: 3-4 weeks
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Care bundle includes risk assessment, skin assessment, skin care, repositioning, regulating nutrition and fluid intake.
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3-4 weeks
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Braden Risk Assessment Tool
Time Frame: 1 hour
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With this tool, six parameters of the patient's stimulant perception, activity, mobility, the effect caused on the skin by humidity, friction, and shearing tension are measured.
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1 hour
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GALTAS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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