search
Back to results

Prevention to Pressure Injury With Care Bundle

Primary Purpose

Pressure Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pressure Injury Prevention Care Bundle
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Injury focused on measuring Bundle care, Pressure injury, Intensive care, Nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gülnaz Altaş

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

Routine clinical care continued to be provided to the patients in the control group. Routine maintenance applications include the following parameters; Risk assessment using Braden Risk Scale Positioning Elevate the heels.

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; Risk Assessment Skin Assessment Skin Care Positioning Regulation of Nutrition and Liquid Management

Outcomes

Primary Outcome Measures

Patient Information Form
The form prepared by the researcher includes questions inquiring about the sociodemographic and background information of the patients, clinical characteristics and laboratory results.
Pressure Injury Prevention Care Bundle
Care bundle includes risk assessment, skin assessment, skin care, repositioning, regulating nutrition and fluid intake.
Braden Risk Assessment Tool
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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2022
Last Updated
September 12, 2022
Sponsor
Saglik Bilimleri Universitesi
search

1. Study Identification

Unique Protocol Identification Number
NCT05541198
Brief Title
Prevention to Pressure Injury With Care Bundle
Official Title
Evaluation of Pressure Injury Prevention Care Bundle Application in Intensive Care Unit Patients Diagnosed With Internal Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
June 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury
Keywords
Bundle care, Pressure injury, Intensive care, Nursing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Routine clinical care continued to be provided to the patients in the control group. Routine maintenance applications include the following parameters; Risk assessment using Braden Risk Scale Positioning Elevate the heels.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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; Risk Assessment Skin Assessment Skin Care Positioning Regulation of Nutrition and Liquid Management
Intervention Type
Other
Intervention Name(s)
Pressure Injury Prevention Care Bundle
Intervention Description
Risk Assessment Skin Assessment Skin Care Positioning Regulation of Nutrition and Liquid Management
Primary Outcome Measure Information:
Title
Patient Information Form
Description
The form prepared by the researcher includes questions inquiring about the sociodemographic and background information of the patients, clinical characteristics and laboratory results.
Time Frame
60 minutes
Title
Pressure Injury Prevention Care Bundle
Description
Care bundle includes risk assessment, skin assessment, skin care, repositioning, regulating nutrition and fluid intake.
Time Frame
3-4 weeks
Title
Braden Risk Assessment Tool
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Gülnaz Altaş
City
Istanbul
State/Province
Istanbul, Uskudar, Turkey
ZIP/Postal Code
34668
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.epuap.org/pu-guidelines/
Description
guidelines
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5098472/
Description
article
URL
https://dergipark.org.tr/tr/pub/aktd/issue/28690/306004
Description
article
URL
http://www.yoihd.org.tr/sayfa.aspx?id=142.
Description
article
URL
https://dergipark.org.tr/en/pub/ausbid/issue/67542/1003094
Description
article
URL
https://dergipark.org.tr/en/pub/ataunihem/issue/2666/34584
Description
article
URL
https://pubmed.ncbi.nlm.nih.gov/24565372/
Description
article
URL
https://search.trdizin.gov.tr/yayin/detay/335810/
Description
article
URL
https://www.turkiyeklinikleri.com/article/tr-dekubit-ve-basi-ulserleri-85382.html
Description
article
URL
https://atif.sobiad.com/index.jsp?modul=makale-detay&Alan=saglik&Id=AWfsBFORHDbCZb_mQ-td
Description
article

Learn more about this trial

Prevention to Pressure Injury With Care Bundle

We'll reach out to this number within 24 hrs